Expanded Access Program for Maraviroc At Multiple Centers

Sponsor

ViiV Healthcare (Industry)

Overall Status

Completed

CT.gov ID

NCT00426660

Collaborator

(none)

1,047

Enrollment

361

Locations

Arm

Duration (Months)

2.9

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To provide access to maraviroc to patients who have limited or no therapeutic treatment options and to collect more safety data in a broader patient population.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: maraviroc	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

1047 participants

Allocation:

Non-Randomized

Primary Purpose:

Treatment

Official Title:

A Multicenter, Open Label, Expanded Access Trial Of Maraviroc

Study Start Date :

Feb 1, 2007

Actual Primary Completion Date :

Jun 1, 2010

Actual Study Completion Date :

Jun 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: maraviroc The nominal dose for maraviroc is 300 mg twice a day (BID). However, the dosage of maraviroc should be adjusted based on optimal background therapy (OBT) patient is taking. If OBT includes CYP3A4 inhibitor (with or without inducers) maraviroc dose should be 150 mg BID and if OBT includes CYP3A4 inducer (without inhibitors) maraviroc dose should be 600mg BID. If OBT does not include any CYP3A4 inducers or inhibitors maraviroc dose should be 300 mg BID.

Arm

Intervention/Treatment

Experimental: 1

Drug: maraviroc

The nominal dose for maraviroc is 300 mg twice a day (BID). However, the dosage of maraviroc should be adjusted based on optimal background therapy (OBT) patient is taking. If OBT includes CYP3A4 inhibitor (with or without inducers) maraviroc dose should be 150 mg BID and if OBT includes CYP3A4 inducer (without inhibitors) maraviroc dose should be 600mg BID. If OBT does not include any CYP3A4 inducers or inhibitors maraviroc dose should be 300 mg BID.

Outcome Measures

Primary Outcome Measures

Percentage of Participants With Grade 3 and Grade 4 Adverse Events (AE) [Baseline up to Week 144]
AEs as defined by the Division of AIDS (DAIDS) toxicity grading scale: Grade 3 = severe: interrupted usual daily activity and traditionally required systemic drug therapy or other treatment. Grade 4 = very severe: events that were unacceptable and intolerable or were irreversable or caused imminent danger of death. If same participant had more than 1 occurrence in the same preferred term event category, only the most severe (grade 4) occurrence was taken. Treatment-related = investigator assessment of a reasonable possibility that the investigational product caused or contributed to the AE.
Percentage of Participants With Grade 3 Laboratory Abnormalities Without Regards to Baseline Abnormalities [Baseline up to Week 144]
Laboratory abnormalities as defined by the Division of AIDS (DAIDS) toxicity grading scale: Grade 3, Severe =events that interrupted participants usual daily activity and traditionally required systemic drug therapy or other treatment.
Percentage of Participants With Grade 4 Laboratory Abnormalities Without Regards to Baseline Abnormalities [Baseline up to Week 144]
Laboratory abnormalities as defined by the Division of AIDS (DAIDS) toxicity grading scale: Grade 4, Very Severe = events which were unacceptable and intolerable or were irreversible or caused the participant to be in imminent danger of death.
Percentage of Participants With Acquired Immunodeficiency Syndrome (AIDS)-Defining Illnesses [Baseline up to Week 144]
Treatment-emergent AIDS-defining opportunistic illnesses based on investigator classification guided by a predefined list of clinical Category C adverse events per Center for Disease Control (CDC) HIV Classification System. Includes events occurring up to 30 days after last dose of study drug.
Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Baseline Viral Load [Baseline up to Week 144]
Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Baseline/Nadir CD4 Cell Counts [Baseline up to Week 144]
Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Time on Therapy [Baseline up to Week 144]
Percentage of Participants With All Causality Treatment-emergent Adverse (AEs) Events by Gender [Baseline up to Week 144]
Treatment-emergent AEs by gender that occurred up to 30 days after the last dose of study medication.
Percentage of Participants With Treatment-emergent Adverse Events (AEs) by Race [Baseline up to Week 144]
Treatment-emergent AEs by race that occurred up to 30 days after the last dose of study medication.
Percentage of Participants With Treatment-emergent Adverse Events (AEs) by Age [Baseline up to Week 144]
Treatment-emergent AEs by age that occurred up to 30 days after the last dose of study medication.
Percentage of Participants With Treatment-emergent Averse Events (AEs) by Baseline Hepatitis B and Hepatitis C Virus Serology Status [Baseline up to Week 144]
Treatment emergent AEs by hepatis B and hepatitis C serology status that occurred up to 30 days post last dose.

Secondary Outcome Measures

Percentage of Participants With ≥0.5 log10 Reduction From Baseline in Human Immunodeficiency Virus 1 Ribonucleic Acid (HIV 1 RNA) [Baseline up to Week 144]
Defined as HIV-1 RNA levels < 400 Copies/mL or at least 0.5 Log 10-decrease from baseline in HIV-1 RNA levels. Baseline value calculated as average of the screening and baseline values if both values were within 1 log10 difference.
Percentage of Participants With ≥1.0 log10 Reduction From Baseline in HIV 1 RNA [Baseline up to Week 144]
Defined as HIV-1 RNA levels < 400 copies/mL or at least 1.0 Log 10-decrease from baseline in HIV-1 RNA levels. Baseline value calculated as average of the screening and baseline values if both values were within 1 log10 difference.
Percentage of Participants With HIV-1 RNA Levels Below the Limit of Quantification: <400 Copies/mL [Baseline up to Week 144]
Limit of quantification defined as <400 copies/mL. Baseline value calculated as average of the screening and baseline values if both values were within 1 log 10 difference.
Percentage of Participants With HIV-1 RNA Levels Below the Limit of Quantification: <50 Copies/mL [Baseline up to Week 144]
Limit of quantification defined as <50 copies/mL. Baseline value calculated as average of the screening and baseline values if both values were within 1 log 10 difference.
Change From Baseline in CD4 Cell Count [Baseline up to Week 144]
Change from baseline in cluster of differentiation 4 helper T cells (CD4) cell count. If baseline value was not available, it was taken from immediate preceding non-missing value.
Change From Baseline in CD4 Cell Count Percent [Baseline up to Week 144]
Change from baseline in CD4 cell count percent . If baseline value was not available, it was taken from immediate preceding non-missing value.
Change From Baseline in CD8 Cell Count [Baseline up to Week 144]
Change from baseline in cluster of differentiation 8 suppressor T cells (CD8) cell count. If baseline value was not available, it was taken from immediate preceding non-missing value.
Change From Baseline in CD8 Cell Count Percent [Baseline up to Week 144]
Change from baseline in CD8 cell count percent . If baseline value was not available, it was taken from immediate preceding non-missing value.
Median Time to Virologic Failure [Day 1 up to Week 144]
Computed as time from the first dose of study medication to the loss of virologic response. Virologic failure defined as: failure to achieve a reduction from baseline (BL) in HIV 1 RNA ≥ 0.5 log10 copies /mL by the second viral load determination (unless viral load was below the lower limit level of quantification [LLOQ]); or a ≥ 0.5 log10 increase from nadir in HIV 1 RNA after achieving a HIV 1 RNA reduction from BL >0.5 log10 copies/mL; or a HIV 1 RNA level of >1000 copies/mL after having achieved a HIV 1 RNA level below LLOQ.
Percentage of Participants With Changes in HIV-1 RNA Level in Participants Meeting the Definition of Virologic Failure [Baseline up to Week 144]
Reasons for virologic failure: A) failure to achieve a reduction in HIV-1 RNA>=0.5 log10 copies/ml from baseline (BL) by second viral load determination (unless below level of quantification [LOQ]); B) >=0.5 log10 increase from nadir in HIV-1 RNA after achieving an HIV-1 RNA reduction from BL >0.5 log10 copies/ml ; C) HIV-1 RNA >1000 copies/ml after having achieved an HIV-1 RNA below LOQ.
Percentage of Participants With Change in Chemokine Co-receptor Tropism From Screening to Time of Virologic Failure [Screening up to Week 144]
Tropism status (CCR5 [R5], CXCR4 [X4], Dual Mixed [DM], or Non-reportable [NR]) at Screening (Scr) and time of virologic failure (V fail). Virologic failure defined as: failure to achieve a reduction from baseline (BL) in HIV 1 RNA ≥0.5 log10 copies/mL by second viral load determination (unless viral load was below lower limit level of quantification [LLOQ]); or a ≥ 0.5 log10 increase from nadir in HIV 1 RNA after achieving HIV 1 RNA reduction from BL >0.5 log10 copies/mL; or a HIV 1 RNA level of >1000 copies/mL after having achieved a HIV 1 RNA level below LLOQ.
Number of Participants With Reduced Maraviroc Susceptibility as Defined by Change From Baseline to Time of Virologic Failure in Inhibitory Concentration of 50% (IC 50) and Presence of Plateau [Baseline up to Week 144]
Resistance to maravroc in viruses from participants failing therapy with R5 virus was investigated using the in vitro phenotypic (drug susceptibility) assay. The number of participants who failed with R5 virus were assessed successfully for maraviroc susceptibility at Baseline and Last on--treatment (Week 144). Samples were analyzed for change from Baseline to time of virologic failure in IC 50 and presence of plateau. A maximal percent inhibition (MPI) <95% established as a plateau in inhibition at high concentrations of maraviroc was used to identify viruses which had reduced phenotypic susceptibility to maraviroc.
Number of Participants With Emergence of Resistance to Maraviroc as Defined by Genotypic Changes in the V3 Loop of Glycoprotein 120 (gp 120) [Baseline up to Week 144]
Virus from participants who experienced virologic failure was analyzed for resistance to maraviroc. Resistance testing was performed on archived samples of participants which were available pre--treatment at time of virologic failure. For participants who met definition of virologic failure during the trial, the sequencing of the V3 loop of HIV--1 viral envelope gp 120 was evaluated to identify any amino acid changes concomitant with decreased susceptibility to maraviroc.

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subjects must be failing to achieve adequate virologic suppression on their current regimen and have HIV-1 RNA greater than or equal to 1000 copies/ml, at screening
Have only R5 HIV-1 at Screening as verified by the Monogram Biosciences Trofile assay
Minimum age must be 16 years or minimum adult age as determined by local regulatory authorities or directed by local law.

Exclusion Criteria:

Failed prior treatment with any CCR5 antagonist, in any ongoing CCR5 trial or having previously prematurely discontinued Maraviroc in trials

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Alabama	Birmingham	Alabama	United States	35294-2050
2	Health Services Center	Hobson City	Alabama	United States	36201
3	El Rio, Special Immunology Associates	Tucson	Arizona	United States	85745
4	Health for Life Clinic PLLC	Little Rock	Arkansas	United States	72207
5	Thomas T Jefferson, MD	Little Rock	Arkansas	United States	72207
6	Vista Medical	Beverly Hills	California	United States	90210-4212
7	AHF Research Center	Beverly Hills	California	United States	90211
8	Orange County Center for Special Immunology	Fountain Valley	California	United States	92708
9	Kaiser Permanente	Hayward	California	United States	94545
10	Living Hope Clinical Trials	Long Beach	California	United States	90813
11	AltaMed Health Services Corporation	Los Angeles	California	United States	90022
12	Kaiser Permanente Medical Center	Los Angeles	California	United States	90027
13	Robert Bolan, MD	Los Angeles	California	United States	90028
14	Maternal-Child and Adolescent Clinic of Infectious Diseases and Virology	Los Angeles	California	United States	90033
15	Peter J. Ruane, M.D. Inc.	Los Angeles	California	United States	90036
16	Synergy Hematology-Oncology Associates	Los Angeles	California	United States	90036
17	Cedars-Sinai Medical Center	Los Angeles	California	United States	90048
18	Erlmed Corp ABA Lim-Keith Muiltispecialty Clinic Inc.	Los Angeles	California	United States	90048
19	Office of Anthony Mills, MD	Los Angeles	California	United States	90069
20	Office of Dr. Salah Bibi, MD	Modesto	California	United States	95350
21	Bonnie V Bock MD	Newport Beach	California	United States	92663
22	Alta Bates Summit Medical Center	Oakland	California	United States	94609
23	Desert Medical Group, Clinical Research Center	Palm Springs	California	United States	92262
24	Riverside Medical Clinic	Riverside	California	United States	92506
25	Fort Sutter Medical Complex	Sacramento	California	United States	95816
26	Sutter Institute for Medical Research	Sacramento	California	United States	95816
27	Sutter Medical Group	Sacramento	California	United States	95816
28	Quest Clinical Research	San Francisco	California	United States	94115-3029
29	Kaiser Permanente Medical Center	San Francisco	California	United States	94118
30	Kaiser Permanente Santa Clara	Santa Clara	California	United States	95051
31	Shared Medical Research Foundation	Tarzana	California	United States	91356
32	Tarzana Treatment Center	Tarzana	California	United States	91356
33	Bipin Bhagat MD Inc.	Victorville	California	United States	92395
34	Kaiser Permanente Colorado	Denver	Colorado	United States	80205
35	Kaiser Permanente of Colorado	Denver	Colorado	United States	80205
36	Denver Infectious Disease Consultants, PLLC	Denver	Colorado	United States	80220
37	Kaiser Permanente of Colorado	Lafayette	Colorado	United States	80026
38	Connecticut Health Care Group	Glastonbury	Connecticut	United States	06033
39	Infectious Disease Clinic	Norwich	Connecticut	United States	06360
40	Dupont Circle Physicians Group	Washington	District of Columbia	United States	20009
41	Internal Medicine Associates of Lee County	Bonita Springs	Florida	United States	34134
42	Infectious Disease Research Corp	Boynton Beach	Florida	United States	33426
43	Internal Medicine Associates of Lee County	Cape Coral	Florida	United States	33990
44	Daniel Warner M.D., P.A. Consultive Medicine	Daytona Beach	Florida	United States	32117
45	Northpoint Medical, PA	Fort Lauderdale	Florida	United States	33308
46	Comprehensive Care Center	Fort Lauderdale	Florida	United States	33311
47	Office of Gary J. Richmond, MD	Fort Lauderdale	Florida	United States	33316
48	Internal Medicine Associates of Lee County	Fort Myers	Florida	United States	33912
49	Therafirst Medical Centers	Ft. Lauderdale	Florida	United States	33308
50	Sunshine Medical Institute	Hollywood	Florida	United States	33021
51	Osler Medical Inc.	Melbourne	Florida	United States	32901
52	Office of Albert Canas, MD	Miami Beach	Florida	United States	33139
53	Steinhart Medical Associates	Miami	Florida	United States	33133
54	Care Resource	Miami	Florida	United States	33137
55	Donald Johnson, MD	North Miami Beach	Florida	United States	33162
56	Wohlfeiler, Piperato & Associates, LLC	North Miami Beach	Florida	United States	33169
57	Orlando Immunology Center	Orlando	Florida	United States	32803
58	Infectious Diseases of Central Florida	Orlando	Florida	United States	32806
59	Associates in Infectious Diseases	Port St. Lucie	Florida	United States	34952
60	Barry Rodwick, MD	Safety Harbor	Florida	United States	34695
61	Infectious Diseases Associates	Sarasota	Florida	United States	34239
62	University Hepatitis Center at Bach & Godofsky, MD,PA	Sarasota	Florida	United States	34243
63	All Children's Hospital	St. Petersburg	Florida	United States	33701
64	Eric Nicholson, M.D., P.A.	Tallahassee	Florida	United States	32308
65	University of South Florida	Tampa	Florida	United States	33606
66	University of Sout Florida	Tampa	Florida	United States	33612
67	Midtown Medical Center	Tampa	Florida	United States	33614
68	Donald Watren MD	West Palm Beach	Florida	United States	33401
69	Philip Brachman MD	Atlanta	Georgia	United States	30309
70	Family Health Care of Atlanta	Atlanta	Georgia	United States	30318-2513
71	Midtown West Medical	Atlanta	Georgia	United States	30318
72	Absolute CARE	Atlanta	Georgia	United States	30329
73	Kaiser Permanente	Atlanta	Georgia	United States	30339
74	Atlanta VA Medical Center	Decatur	Georgia	United States	30033
75	Infectious Disease Specialists of Atlanta	Decatur	Georgia	United States	30033
76	Kaiser Permanente	Jonesboro	Georgia	United States	30236
77	Infectious Diseases Associates, PC	Riverdale	Georgia	United States	30274
78	Chatham County Health Department	Savannah	Georgia	United States	31405
79	Infectious Disease Consultants	Tucker	Georgia	United States	30084-8128
80	Ruth M. Rothstein CORE Center	Chicago	Illinois	United States	60612
81	Roger Trinh	Chicago	Illinois	United States	60613
82	Northstar Medical Center	Chicago	Illinois	United States	60657
83	Cotton-O'Neil Clinic	Topeka	Kansas	United States	66606-1670
84	Kansas University Internal Medicine Midtown Clinic	Wichita	Kansas	United States	67214
85	Via Christi Research, Inc.	Wichita	Kansas	United States	67214
86	Chase Brexton Health Services Inc	Baltimore	Maryland	United States	21201
87	Metro Health Care	Greenbelt	Maryland	United States	20770-3525
88	Dr.'s Alpert, Trinh, and Posorske	Silver Spring	Maryland	United States	20910
89	Tufts - New England Medical Center	Boston	Massachusetts	United States	02111
90	Fenway Community Health	Boston	Massachusetts	United States	02115
91	Community Research Initiative of New England	Boston	Massachusetts	United States	02215-3318
92	Community Research Initiative of New England	Springfield	Massachusetts	United States	01107
93	The Office of Dr. Paul A. Benson, DO	Berkley	Michigan	United States	48072
94	Private Practice (Dr. Gregory Kuldanek)	Grand Rapids	Michigan	United States	49546
95	St. John hospital and Medical Center	Grosse Pointe Woods	Michigan	United States	48236
96	Private Practice	Keego Harbor	Michigan	United States	48320
97	MSU Adult Medicine, 10	Lansing	Michigan	United States	48910
98	Hennepin County Medical Center	Minneapolis	Minnesota	United States	55415
99	Nemechek Health Renewal	Kansas City	Missouri	United States	64111
100	Private Practice (Dr. Mark Scheperle)	St. Louis	Missouri	United States	63117
101	Partnership Health Center	Missoula	Montana	United States	59802
102	CPMC Research Pharmacy	Englewood	New Jersey	United States	07631
103	Leonia Medical Associates	Englewood	New Jersey	United States	07631
104	Center for Infectious Diseaes	Hackensack	New Jersey	United States	07601
105	Hackensack University Medical Center	Hackensack	New Jersey	United States	07601
106	UMDNJ	Newark	New Jersey	United States	07103
107	University Hospital	Newark	New Jersey	United States	07103
108	Newark Community Health Center	Newark	New Jersey	United States	07114
109	South Jersey Infectious Disease	Somers Point	New Jersey	United States	08244
110	Premier Medical Research Group	Toms River	New Jersey	United States	08755
111	Garden State Infectious Disease Associates, PA	Voorhees	New Jersey	United States	08043
112	Upstate Infectious Disease Associates	Albany	New York	United States	12208
113	Allmed Medical and Rehabilitaion of NY	Bronx	New York	United States	10454
114	Bronx Lebanon Hospital Center	Bronx	New York	United States	10457
115	Woodhull Medical Center	Brooklyn	New York	United States	11206
116	New York Methodist Hospital	Brooklyn	New York	United States	11215
117	NYM Medical Pavilion	Brooklyn	New York	United States	11215
118	Chiu-Bin Hsiao, MD	Buffalo	New York	United States	14215
119	The Office of Dr. Zale P. Bernstein, MD.	Buffalo	New York	United States	14215
120	NYHQ	Flushing	New York	United States	11367
121	Schneider Children's Hospital	Great Neck	New York	United States	11042
122	North Shore University Hospital, Department of Infectious Disease	Manhasset	New York	United States	11030
123	Astor Medical Group, LLP	New York	New York	United States	10003
124	Beth Israel Medical Center	New York	New York	United States	10003
125	Paul Bellman, MD	New York	New York	United States	10003
126	Sidney Hillman Family Health Center	New York	New York	United States	10003
127	Ricky Hsu	New York	New York	United States	10011
128	Bellevue Hospital	New York	New York	United States	10016
129	NYU School of Medicine	New York	New York	United States	10016
130	Perion Smith	New York	New York	United States	10018
131	James I Jones Jr, MD	New York	New York	United States	10019-1819
132	Sharon Lewin MD and Michael Rendel MD	New York	New York	United States	10024
133	Lenox Ave Clinic	New York	New York	United States	10026
134	Harlem Medical Associates	New York	New York	United States	10029
135	Mount Sinai Medical Center	New York	New York	United States	10029
136	Mount Sinai School of Medicine	New York	New York	United States	10029
137	New York-Presbyterian Hospital	New York	New York	United States	10032
138	Dr. Steven Fine	Rochester	New York	United States	14605
139	Jordon Glaser, MD	Stanton Island	New York	United States	10304
140	SUNY Upstate Medical University	Syracuse	New York	United States	13210
141	ID Associates	Gastonia	North Carolina	United States	28054
142	Rosedale Infectious Diseases	Huntersville	North Carolina	United States	28078
143	Metro Health Systems	Cleveland	Ohio	United States	44109
144	South Dayton Acute Care Consultants Inc.	Dayton	Ohio	United States	45429
145	University of Toledo - Health Science Campus	Toledo	Ohio	United States	43614-5812
146	University of Oklahoma - Schusterman Clinic	Tulsa	Oklahoma	United States	74135
147	The Research & Education Group	Portland	Oregon	United States	97210
148	Kaiser Permanente-Northwest Region, Immune Deficiency Clinic	Portland	Oregon	United States	97227
149	Lehigh Valley Hospital	Allentown	Pennsylvania	United States	18102
150	Philadelphia FIGHT	Philadelphia	Pennsylvania	United States	19107
151	RPS Infectious Diseases	West Reading	Pennsylvania	United States	19611
152	The Miriam Hospital	Providence	Rhode Island	United States	02906
153	Investigational Drug Services	Charleston	South Carolina	United States	29401
154	Medical University of South Carolina	Charleston	South Carolina	United States	29403
155	Medical University of South Carolina	Charleston	South Carolina	United States	29425
156	Infectious Disease Associates of Memphis	Memphis	Tennessee	United States	38119
157	The Office of Dr. Nicholaos C. Bellos, MD	Dallas	Texas	United States	75204
158	The Office of Dr. Patrick W. Daly, MD.	Dallas	Texas	United States	75219
159	The Office of Dr. Susan M. Diamond, MD.	Dallas	Texas	United States	75231
160	La Fe CARE Center Clinic	El Paso	Texas	United States	79925
161	Kelly, Allan Rowman MD	Fort Worth	Texas	United States	76104-3048
162	Tarrant County Infectious Disease Associates	Ft. Worth	Texas	United States	76104
163	Fernando Garcia, MD	Harlingen	Texas	United States	78550
164	Harris County Hospital District	Houston	Texas	United States	77009
165	Thomas Street Clinic	Houston	Texas	United States	77009
166	Diversified Medical Practices, PA	Houston	Texas	United States	77027
167	Baylor College of Medicine	Houston	Texas	United States	77030
168	The University of Texas Health Sciences Center at Houston	Houston	Texas	United States	77030
169	Brewton, Gary W MD	Houston	Texas	United States	77098-2807
170	Research Access Network	Houston	Texas	United States	77098
171	The Office of Dr. Gordon E. Crofoot, MD.	Houston	Texas	United States	77098
172	DCOL Center for Clinical Research	Longview	Texas	United States	75605
173	Diagnostic Clinic of Longview, PA	Longview	Texas	United States	75605
174	Dr. James Bromley	San Antonio	Texas	United States	78212
175	Responsive ID Solutions	San Antonio	Texas	United States	78258
176	Clinical Alliance for Research & Education - Infectious Diseases	Annandale	Virginia	United States	22003
177	Infectious Diseases	Arlington	Virginia	United States	22205-3633
178	Infectious Diseases Associates of Central Virginia	Danville	Virginia	United States	24541
179	Infectious Disease Consultants	Fairfax	Virginia	United States	22030
180	Hampton Roads Medical Specialists	Hampton	Virginia	United States	23666
181	Barbara Cassie	Lynchburg	Virginia	United States	24501
182	Crossover Ministry	Richmond	Virginia	United States	23224
183	William F. Ehni, MD	Edmonds	Washington	United States	98026
184	Emerald City Medical Arts	Seattle	Washington	United States	98109
185	Group Health Cooperative	Seattle	Washington	United States	98112
186	The Office of Dr. Daniel R. Coulston, MD	Spokane	Washington	United States	99204
187	The Vancouver Clinic, Inc., P.S.	Vancouver	Washington	United States	98664
188	CAMC Memorial Hospital	Charleston	West Virginia	United States	25304
189	Clinical Trials Center	Charleston	West Virginia	United States	25304
190	University Physicians Internal Medicine	Huntington	West Virginia	United States	25701
191	Fundacion Huesped, Departamento de Investigacion Clinica	Buenos Aires		Argentina	C1202ABB
192	FUNCEI	Buenos Aires		Argentina	C1425AWK
193	Holdsworth House Medical Practice	Darlinghurst	New South Wales	Australia	2010
194	St. Vincent's Hospital	Darlinghurst	New South Wales	Australia	2010
195	Albion Street Centre	Surry Hills	New South Wales	Australia	2010
196	Westmead Hospital	Wentworthville	New South Wales	Australia	2145
197	AIDS Medical Centre	Brisbane	Queensland	Australia	4000
198	Infectious Diseases Unit	Herston	Queensland	Australia	4029
199	Infectious Diseases Unit	Adelaide	South Australia	Australia	5000
200	Melbourne Sexual Health Centre	Carlton	Victoria	Australia	3053
201	Clinical Research Unit, Infectious Diseases	Melbourne	Victoria	Australia	3004
202	Northside Clinic	North Fitzroy	Victoria	Australia	3068
203	Prahran Market Clinic	South Yarra	Victoria	Australia	3141
204	Allgemeines Krankenhaus Wien	A-1090		Austria
205	Landeskrankenhaus Graz West / Abteilung fuer Innere Medizin 1	Graz		Austria	A-8020
206	Sozialmedizinisches Zentrum Baumgartner Hoehe / 2. Interne Lungenabteilung	Wien		Austria	A-1140
207	Instituut voor Tropische Geneeskunde, Inwendige Geneeskunde	Antwerpen		Belgium	2000
208	Centre Hospitalier Universitaire Saint-Pierre, Maladies Infectieuses	Bruxelles		Belgium	1000
209	Hôpital Erasme, Médecine Interne	Bruxelles		Belgium	1070
210	Cliniques Universitaires Saint-Luc, Maladies Infectieuses	Bruxelles		Belgium	1200
211	Centre Hospitalier Universitaire de Charleroi, Médecine Interne	Charleroi		Belgium	6000
212	Universitair Ziekenhuis Gent, Inwendige Geneeskunde	Gent		Belgium	9000
213	Academisch Ziekenhuis VUB	Jette		Belgium	B-1090
214	Universitair Ziekenhuis Gasthuisberg, Inwendige Geneeskunde	Leuven		Belgium	3000
215	CHU Sart-Tilman, Medecine Interne	Liège		Belgium	4000
216	Queen Elizabeth II Health Sciences Center	Halifax	Nova Scotia	Canada	B3H 1V7
217	Hamilton Health Sciences - McMaster University Medical Centre	Hamilton	Ontario	Canada	L8N 3Z5
218	Sunnybrook Health Sciences Centre	Toronto	Ontario	Canada	M4N 3M5
219	Canadian Immunodeficiency Research Collaborative	Toronto	Ontario	Canada	M5B 1L6
220	Clinique médicale l'Actuel	Montreal	Quebec	Canada	H2L 4P9
221	Clinique Medicale du Quartier Latin	Montreal	Quebec	Canada	H2L 5B1
222	CHUM Hôtel-Dieu	Montreal	Quebec	Canada	H2W 1T8
223	Projet L.O.R.I.	Montreal	Quebec	Canada	H3H 1V1
224	Hospital Clínica Universidad Católica	Santiago	RM	Chile	8330023
225	Hospital Clínico San Borja Arriarán	Santiago	RM	Chile	8360160
226	Fundación para el Desarrollo de la Lucha contra el SIDA	Barrio Aranjuez	San Jose	Costa Rica
227	Instituto Dominicano de Estudios Virologicos	Santo Domingo		Dominican Republic
228	Hopital Sainte Marguerite	Marseille	Cedex 09	France	13274
229	Hopital Saint Antoine	Paris	Cedex 12	France	75571
230	Centre Hospitalier Universitaire de Caen	Caen	Cedex	France	14033
231	Hôpital Saint Jacques	Besancon		France	25030
232	Hopital Avicenne	Bobigny Cedex		France	93009
233	Hôpital Saint-andré	Bordeaux Cedex		France	33075
234	Hopital Pellegrin - Service des Maladies Infectieuses et Medecine Interne	Bordeaux		France	33076
235	Hopital Gabriel Montpied	Clermont Ferrand		France	63000
236	CHU Michallon	Grenoble Cedex 09		France	38043
237	Hopital La Source	La Source		France	45100
238	Hopital de Bicêtre	Le Kremlin Bicêtre		France	94270
239	Hopital de l'Hotel-Dieu, Service d'Hepato-Gastroenterologie	Lyon Cedex 02		France	69288
240	Hôpital de la Croix Rousse	Lyon Cedex 04		France	690317
241	Hopital Gui de Chauliac	Montpellier		France	34295
242	CHU de Nantes - Hopital Hotel Dieu	Nantes		France	44093
243	Hopital de l Archet 1	Nice Cedex 3, 06		France	06202
244	Hopital Saint-Louis	Paris Cedex 10		France	75475
245	Centre Hospitalier Cochin Saint Vincent de Paul	Paris CEDEX 14		France	75679
246	Hôpital Necker-Service des Maladies Infectieuses et Tropicales	Paris cedex 15		France	75743
247	Hôpital de la Pitié Salpétrière	Paris		France	75013
248	Hopital Europeen George Pompidou	Paris		France	75015
249	Hopital Bichat-Claude Bernard, Service des Maladies Infectieuses	Paris		France	75018
250	Hopital Tenon, Service des Maladies Infectieuses	Paris		France	75020
251	Chu Pontchaillou, Service des maladies infectieuses	Rennes		France	35033
252	Hôpital de Purpan	Toulouse		France	31059
253	CHU de Tourcoing	Tourcoing		France	59208
254	Hopital Paul Brousse	Villejuif		France	94800
255	Praxisgemeinschaft Bieniek & Cordes	Berlin		Germany	10243
256	Universitaetsklinikum Carl Gustav Carus, Klinik und Poliklinik fuer Dermatologie	Dresden		Germany	01307
257	Universitaetsklinikum Essen, HIV-Ambulanz, Hautklinik	Essen		Germany	45122
258	Gemeinschaftspraxis Dres. Rump und Usadel	Freiburg		Germany	79098
259	Medizinische Hochschule Hannover, Klinische Immunologie, Zentrum Innere Medizin	Hannover		Germany	30625
260	Universitaetsklinikum Koeln, Klinik I fuer Innere Medizin,	Koeln		Germany	50937
261	Evagelismos Hospital	Athens	Attiki	Greece	10676
262	Greek Red Cross Hospital	Athens	Attiki	Greece	115 26
263	General Hospital of Athens G. Gennimatas	Athens		Greece	115 27
264	Andreas Sygros Hospital	Athens		Greece	161 21
265	University Hospital of Patras	Patras		Greece	265 00
266	Regional General Hospital Tzaneio	Piraeus		Greece	185 36
267	AHEPA Hospital	Thessaloniki		Greece	54636
268	Department of Medicine Queen Elizabeth Hospital	Kowloon		Hong Kong
269	Department of Medicine, St. John's Medical College Hospital	Bangalore	Karnataka	India	560 034
270	Department of HIV Medicine (I D Clinic), Jaslok Hospital & Research Centre	Mumbai	Maharashtra	India	400 026
271	YR Gaitonde Centre for AIDS Research and Education (YRG CARE)	Chennai	Tamil Nadu	India	600 113
272	Catherine McAuley Centre	Dublin		Ireland	7
273	St. James's Hospital	Dublin		Ireland	8
274	Universita' degli Studi di Bari, Clinica Malattie Infettive, Policlinico	Bari		Italy	70124
275	Unita' Operativa Malattie Infettive	Bologna		Italy	40138
276	Istituto di Malattie Infettive e Tropicali	Brescia		Italy	25123
277	Unita' Operativa di Malattie Infettive	Catania		Italy	95126
278	Presidio Ospedaliero SS Annunziata	Chieti Scalo		Italy	66100
279	Arcispedale S. Anna Azienda Ospedaliera Universitaria di Ferrara	Ferrara		Italy	44100
280	SOD Malattie Infettive, La Piastra dei Servizi	Firenze		Italy	50100
281	Unita' Operativa Clinica Malattie Infettive, Dipartimento di Medicina Interna e Malattie Infettive	Genova		Italy	16132
282	Fondazione Centro San Raffaele del Monte Tabor	Milano		Italy	20127
283	Dipartimento di Scienze Cliniche, Divisione Clinicizzata Malattie Infettive	Milano		Italy	20157
284	Clinica Malattie Infettive e Tropicali, Universita' degli Studi di Modena Reggio Emilia	Modena		Italy	41100
285	Unita Operativa di Malattie Infettive e Tropicali	Padova		Italy	35128
286	Fondazione IRCCS Policlinico S. Matteo	Pavia		Italy	27100
287	Reparto di Malattie Infettive, Azienda Sanitaria Locale	Pescara		Italy	65124
288	Policlinico Tor Vergata, Divisione Malattie Infettive	Roma		Italy	00133
289	IRCCS Lazzaro Spallanzani Istituto Nazionale per la Malattie Infettive	Roma		Italy	00149
290	IRCCS Lazzaro Spallanzani Istituto Nazionale per le Malattie Infettive	Roma		Italy	00149
291	IRCCS Lazzaro Spallanzani, Istituto Nazionale per le Malattie Infettive	Roma		Italy	00149
292	Dipartimento di Malattie Infettive e Tropicali, Universita' di Roma La Sapienza	Roma		Italy	00161
293	Universita'Cattolica del Sacro Cuore Policlinico Gemelli	Roma		Italy	00168
294	Azienda Ospedaliera San Giovanni Addolorata	Roma		Italy	00184
295	Clinica Universitaria di Malattie Infettive, Ospedale Amedeo di Savoia	Torino		Italy	10149
296	Uni. Politecnica delle Marche, Ist. Malattie Infettive e Medicina P.	Torrette di Ancona		Italy	60121
297	Unita' Operativa di Malattie Infettive	Venezia		Italy	30122
298	Physician Clinic	Kota Bharu	Kelantan	Malaysia	15586
299	Hospital Sungai Buloh	Sungai Buloh	Selangor	Malaysia	47000
300	Hospital Regional Lic. Adolfo Lopez Mateos	Mexico	DF	Mexico	01030
301	Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"	Guadalajara	Jalisco	Mexico	44280
302	Instituto Nacional de Ciencias Medicas Y Nutricion Dr Salvador Zubiran	Tlalpan	Mexico Df	Mexico	CP 14000
303	Academisch Ziekenhuis Utrecht	Utrecht		Netherlands	NL 3584 CX
304	Centro Hospitalar de Cascais	Cascais		Portugal	2750-349
305	Centro Hospitalar de Lisboa - Zona Central - Hospital Santo António Capuchos	Lisboa		Portugal	1169-050
306	Hospital Sta. Maria	Lisbon		Portugal	1649-035
307	Hospital São João	Porto		Portugal	4200-319
308	Centro Ararat Inc	Ponce		Puerto Rico	00717-1563
309	HOPE Clinical Research	San Juan		Puerto Rico	00909
310	Institutul de Boli Infectioase "Prof. Matei Bals"	Bucuresti	Sector 2	Romania	021105
311	Spitalul de Boli Infectioase si Tropicale Victor Babes	Bucharest		Romania	030303
312	Spitalul Clinic de Boli Infectioase Constanta	Constanta		Romania	900709
313	Spitalul Clinic de Boli Infectioase Sf. Parascheva	Iasi		Romania	700116
314	Hospital General Universitario de Elche	Elche	Alicante	Spain	03202
315	H. Universitari Germans Trias I Pujol	Badalona	Barcelona	Spain	08916
316	Hospital General de Granollers	Granollers	Barcelona	Spain	08400
317	Hospital Universitari de Bellvitge	Hospitalet de Llobregat	Barcelona	Spain	08907
318	Hospital de Basurto	Basurto	Bilbao	Spain	48078
319	Hospital Universitario Marques de Valdecilla	Santander	Cantabria	Spain	39008
320	Hospital de Cabueñes	Cabueñes	Gijon	Spain	33394
321	Hospital Clinico Universitario de Santiago de Compostela	Santiago de Compostela	La Coruña	Spain	15706
322	Complejo Hospitalario Xeral-Cies	Vigo	Pontevedra	Spain	36204
323	Hospital Donostia-Donostia Ospitalea	Donostia	San Sebastian	Spain	20014
324	Hospital Universitario de Canarias	La Laguna	Santa Cruz de Tenerife	Spain	38320
325	Hospital de Tortosa Verge de La Cinta	Tortosa	Tarragona	Spain	43500
326	Hospital de Cruces	Barakaldo	Vizcaya	Spain	48903
327	Hospital General Universitario de Alicante	Alicante		Spain	03010
328	Hospital Del Mar	Barcelona		Spain	08003
329	Fund. de Gest. Sanitaria de L' Hospital de La Sta. Creu I Sant Pau	Barcelona		Spain	08025
330	Hospital Universitari Vall D'Hebron	Barcelona		Spain	08035
331	Hospital Clinic I Provincial de Barcelona	Barcelona		Spain	08036
332	Hospital Puerta Del Mar	Cadiz		Spain	11009
333	Hospital Universitario Reina Sofia	Cordoba		Spain	14012
334	Hospital Universitario San Cecilio	Granada		Spain	18012
335	Hospital Universitario Virgen de Las Nieves	Granada		Spain	18014
336	Hospital Universitario de La Princesa	Madrid		Spain	28006
337	Hospital General Gregorio Marañon	Madrid		Spain	28007
338	Hospital Carlos Iii	Madrid		Spain	28029
339	Hospital Ramon Y Cajal	Madrid		Spain	28034
340	Fundacion Jimenez Diaz	Madrid		Spain	28040
341	Hospital 12 de Octubre	Madrid		Spain	28041
342	Hospital Universitario La Paz	Madrid		Spain	28046
343	Complejo Hospitalario Carlos Haya	Malaga		Spain	29010
344	Hospital Virgen de La Victoria	Malaga		Spain	29010
345	Hospital Costa Del Sol	Malaga		Spain	29600
346	Hospital Virgen Del Rocio	Sevilla		Spain	41013
347	Complejo Hospitalario Nuestra Señora de Valme	Sevilla		Spain	41014
348	Hospital Universitario Virgen de La Macarena	Sevilla		Spain	41071
349	Hospital Universitario La Fe	Valencia		Spain	46009
350	Hospital Clinico Universitario	Valencia		Spain	46010
351	Consorcio Hospital General Universitario de Valencia	Valencia		Spain	46014
352	Hospital Arnau de Vilanova	Valencia		Spain	46015
353	Universitätsspital Zürich	Zürich		Switzerland	8091
354	Department of Infectious Disease, E-Da Hospital	Kaohsiung County		Taiwan	824
355	Brighton and Sussex University Hospitals NHS Trust, The Elton John Centre	Brighton	Sussex	United Kingdom	BN2 1ES
356	North Manchester General Hospital	Crumpsall, Manchester		United Kingdom	M8 6RB
357	Regional Infectious Diseases Unit	Edinburgh		United Kingdom	EH4 2XU
358	Ian Charleson Centre	London		United Kingdom	NW3 2QG
359	Department of Sexual Health	London		United Kingdom	SE5 9RS
360	St Stephens Research Ltd	London		United Kingdom	SW10 9NH
361	Imperial College	London		United Kingdom	W2 1NY

Sponsors and Collaborators

ViiV Healthcare

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

To obtain contact information for a study center near you, click here.

Publications

None provided.

Responsible Party:

ViiV Healthcare

ClinicalTrials.gov Identifier:

NCT00426660

Other Study ID Numbers:

A4001050
2006-004306-50
EAP
NCT02783001

First Posted:

Jan 25, 2007

Last Update Posted:

Jun 29, 2016

Last Verified:

May 1, 2016

Keywords provided by ViiV Healthcare

HIV Infections

Additional relevant MeSH terms:

HIV Infections

Maraviroc

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail	Of 2584 participants screened, 1047 participants were enrolled in the study.

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
Period Title: Overall Study
STARTED	1047
Treated	1032
Safety Analysis Set	1032
COMPLETED	916
NOT COMPLETED	131

Baseline Characteristics

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
Overall Participants	1032
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45.6 (8.6)
Sex: Female, Male (Count of Participants)
Female	205 19.9%
Male	827 80.1%
Baseline Viral Load: Absolute Value (copies/mL) [Mean (Standard Deviation) ]
Overall: Absolute (N=979)	117846.1 (321426.5)
< 100,000: Absolute (N=729)	22395.9 (25974.4)
>= 100,000: Absolute (N=250)	396179.0 (547142.6)
Baseline Viral Load: Absolute Value (copies/mL) [Median (Full Range) ]
Overall: Absolute (N=979)	25109.5
< 100,000: Absolute (N=729)	11028.5
>= 100,000: Absolute (N=250)	234750.0
Baseline Viral Load: Log Scale (log10 copies/mL) [Mean (Standard Deviation) ]
Overall: Log Scale (N=979)	4.259 (1.0182)
< 100,000: Log Scale (N=729)	3.859 (0.8517)
>= 100,000: Log Scale (N=250)	5.423 (0.3496)
Baseline Viral Load: : Log Scale (log10 copies/mL) [Median (Full Range) ]
Overall: Log Scale (N=979)	4.400
< 100,000: Log Scale (N=729)	4.043
>= 100,000: Log Scale (N=250)	5.371

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Grade 3 and Grade 4 Adverse Events (AE)
Description	AEs as defined by the Division of AIDS (DAIDS) toxicity grading scale: Grade 3 = severe: interrupted usual daily activity and traditionally required systemic drug therapy or other treatment. Grade 4 = very severe: events that were unacceptable and intolerable or were irreversable or caused imminent danger of death. If same participant had more than 1 occurrence in the same preferred term event category, only the most severe (grade 4) occurrence was taken. Treatment-related = investigator assessment of a reasonable possibility that the investigational product caused or contributed to the AE.
Time Frame	Baseline up to Week 144

Outcome Measure Data

Analysis Population Description
Safety analysis set: all participants who were randomized and received at least one dose of study medication.

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
Measure Participants	1032
Grade 3 AE: all causality	13.2 1.3%
Grade 3 AE: treatment related	2.4 0.2%
Grade 4 AE: all causality	6.3 0.6%
Grade 4 AE: treatment related	1.6 0.2%

2. Primary Outcome

Title	Percentage of Participants With Grade 3 Laboratory Abnormalities Without Regards to Baseline Abnormalities
Description	Laboratory abnormalities as defined by the Division of AIDS (DAIDS) toxicity grading scale: Grade 3, Severe =events that interrupted participants usual daily activity and traditionally required systemic drug therapy or other treatment.
Time Frame	Baseline up to Week 144

Outcome Measure Data

Analysis Population Description
Safety analysis set. N = number of participants evaluable for laboratory abnormalities (with at least one observation of a laboratory test while on study treatment or during lag time); n = number of participants with at least one observation of given laboratory test while on study treatment or during lag time.

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
Measure Participants	1014
Alanine aminotransferase (ALT) (n=1013)	2.17 0.2%
Aspartate aminotransferase (AST) (n=1013)	2.07 0.2%
Absolute Neutrophil Count (n=1004)	0.70 0.1%
Alkaline Phosphatase (n=1014)	0.39 0%
Creatinine (n=1014)	0.49 0%
Gamma-glutamyl transpeptidase (GGT) (n=1014)	4.73 0.5%
Hemoglobin (n=1005)	0.20 0%
Hyperbilirubinemia (n=1013)	1.28 0.1%
Hyperuricemia (n=1014)	0.69 0.1%
Hypophosphatemia (n=1014)	0.20 0%
Lipase (n=409)	4.40 0.4%
Platelets (n=997)	1.50 0.1%
Potassium (hyperkalemia) (n=1014)	0.10 0%
Serum Amylase (n=1014)	4.83 0.5%
Sodium (hypernatremia) (n=1014)	0.10 0%
Triglycerides (n=1014)	4.73 0.5%

3. Primary Outcome

Title	Percentage of Participants With Grade 4 Laboratory Abnormalities Without Regards to Baseline Abnormalities
Description	Laboratory abnormalities as defined by the Division of AIDS (DAIDS) toxicity grading scale: Grade 4, Very Severe = events which were unacceptable and intolerable or were irreversible or caused the participant to be in imminent danger of death.
Time Frame	Baseline up to Week 144

Outcome Measure Data

Analysis Population Description
Safety analysis set. N = number of participants evaluable for laboratory abnormalities (with at least one observation of a laboratory test while on study treatment or during lag time); n = number of participants with at least one observation of given laboratory test while on study treatment or during lag time.

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
Measure Participants	1014
ALT (n=1013)	0.79 0.1%
AST (n=1013)	0.39 0%
Absolute Neutrophil Count (n=1004)	0.20 0%
Alkaline Phosphatase (n=1014)	0.00 0%
Creatinine (n=1014)	0.10 0%
GGT (n=1014)	1.48 0.1%
Hemoglobin (n=1005)	0.10 0%
Hyperbilirubinemia (n=1013)	0.30 0%
Hyperuricemia (n=1014)	0.10 0%
Hypophosphatemia (n=1014)	0.00 0%
Lipase (n=409)	1.22 0.1%
Platelets (n=997)	0.30 0%
Potassium (hyperkalemia) (n=1014)	0.20 0%
Serum Amylase (n=1014)	0.30 0%
Sodium (hypernatremia) (n=1014)	0.20 0%
Triglycerides (n=1014)	1.97 0.2%

4. Primary Outcome

Title	Percentage of Participants With Acquired Immunodeficiency Syndrome (AIDS)-Defining Illnesses
Description	Treatment-emergent AIDS-defining opportunistic illnesses based on investigator classification guided by a predefined list of clinical Category C adverse events per Center for Disease Control (CDC) HIV Classification System. Includes events occurring up to 30 days after last dose of study drug.
Time Frame	Baseline up to Week 144

Outcome Measure Data

Analysis Population Description
Safety analysis set.

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
Measure Participants	1032
AIDS encephalopathy	0.1 0%
Bone tuberculosis	0.1 0%
Cytomegalovirus infection	0.2 0%
Extrapulmonary tuberculosis	0.1 0%
Meningitis cryptococcal	0.1 0%
Meningitis tuberculous	0.1 0%
Mycobacterium avium complex infection	0.1 0%
Mycobacterium kansasii infection	0.1 0%
Oesophageal candidiasis	0.6 0.1%
Pancreatitis bacterial	0.1 0%
Pneumocystis jiroveci pneumonia	0.1 0%
Progressive multifocal leukoencephalopathy	0.1 0%
Pulmonary tuberculosis	0.5 0%
Toxoplasmosis	0.1 0%
B-cell lymphoma	0.1 0%
Hodgkin's disease	0.1 0%
Kaposi's sarcoma	0.2 0%
Encephalopathy	0.1 0%

5. Primary Outcome

Title	Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Baseline Viral Load
Description
Time Frame	Baseline up to Week 144

Outcome Measure Data

Analysis Population Description
Safety analysis set. Data not analyzed; the number of possible AIDS-related infections and malignancies and limited data collection during the study in terms of baseline viral load were such that a summary of AIDS-related infections by this parameter was not clinically meaningful.

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
Measure Participants	0

6. Primary Outcome

Title	Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Baseline/Nadir CD4 Cell Counts
Description
Time Frame	Baseline up to Week 144

Outcome Measure Data

Analysis Population Description
Safety analysis set. Data not analyzed; the number of possible AIDS-related infections and malignancies and limited data collection during the study in terms of baseline/nadir CD4 cell counts were such that a summary of AIDS-related infections by this parameter was not clinically meaningful.

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
Measure Participants	0

7. Primary Outcome

Title	Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Time on Therapy
Description
Time Frame	Baseline up to Week 144

Outcome Measure Data

Analysis Population Description
Safety analysis set. Data not analyzed; the number of possible AIDS-related infections and malignancies and limited data collection during the study by time on therapy were such that a summary of AIDS-related infections by this parameter was not clinically meaningful.

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
Measure Participants	0

8. Primary Outcome

Title	Percentage of Participants With All Causality Treatment-emergent Adverse (AEs) Events by Gender
Description	Treatment-emergent AEs by gender that occurred up to 30 days after the last dose of study medication.
Time Frame	Baseline up to Week 144

Outcome Measure Data

Analysis Population Description
Safety analysis set; n = number of participants evaluable for adverse events.

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
Measure Participants	1032
Male (n=827)	69.6 6.7%
Female (n=205)	73.7 7.1%

9. Primary Outcome

Title	Percentage of Participants With Treatment-emergent Adverse Events (AEs) by Race
Description	Treatment-emergent AEs by race that occurred up to 30 days after the last dose of study medication.
Time Frame	Baseline up to Week 144

Outcome Measure Data

Analysis Population Description
Safety analysis set; n = number of participants evaluable for adverse events.

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
Measure Participants	1032
White (n=817)	68.5 6.6%
Black (n=106)	67.9 6.6%
Asian (n=54)	88.9 8.6%
Other Unspecified (n=55)	85.5 8.3%

10. Primary Outcome

Title	Percentage of Participants With Treatment-emergent Adverse Events (AEs) by Age
Description	Treatment-emergent AEs by age that occurred up to 30 days after the last dose of study medication.
Time Frame	Baseline up to Week 144

Outcome Measure Data

Analysis Population Description
Safety analysis set; n = number of participants evaluable for adverse events.

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
Measure Participants	1032
<18 years (n=1)	100.0 9.7%
18 to 44 years (n=515)	71.7 6.9%
45 to 64 years (n=493)	68.6 6.6%
>=65 years (n=23)	82.6 8%

11. Primary Outcome

Title	Percentage of Participants With Treatment-emergent Averse Events (AEs) by Baseline Hepatitis B and Hepatitis C Virus Serology Status
Description	Treatment emergent AEs by hepatis B and hepatitis C serology status that occurred up to 30 days post last dose.
Time Frame	Baseline up to Week 144

Outcome Measure Data

Analysis Population Description
Safety analysis set; n = number of participants evaluable for adverse events. Abbreviations: HBV = hepatitis B virus, HBC = hepatitis C virus.

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
Measure Participants	1032
HBV: negative (n=897)	71.3 6.9%
HBV: positive (n=60)	65.0 6.3%
HBV: missing: (n=75)	64.0 6.2%
HCV: negative (n=794)	72.7 7%
HCV: positive (n=158)	62.7 6.1%
HCV: missing (n=80)	63.8 6.2%

12. Secondary Outcome

Title	Percentage of Participants With ≥0.5 log10 Reduction From Baseline in Human Immunodeficiency Virus 1 Ribonucleic Acid (HIV 1 RNA)
Description	Defined as HIV-1 RNA levels < 400 Copies/mL or at least 0.5 Log 10-decrease from baseline in HIV-1 RNA levels. Baseline value calculated as average of the screening and baseline values if both values were within 1 log10 difference.
Time Frame	Baseline up to Week 144

Outcome Measure Data

Analysis Population Description
Safety analysis set; n = number of participants contributing to summary statistic at given timepoint.

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
Measure Participants	1032
Day 2-7 (n=26)	46.2 4.5%
Week 2 (n=226)	93.8 9.1%
Week 4 (n=773)	93 9%
Week 8 (n=761)	93.2 9%
Week 12 (n=756)	94 9.1%
Week 16 (n=155)	87.7 8.5%
Week 20 (n=131)	93.1 9%
Week 24 (n=557)	91.9 8.9%
Week 32 (n=202)	93.1 9%
Week 40 (n=227)	91.2 8.8%
Week 48 (n=228)	89 8.6%
Week 60 (n=160)	90 8.7%
Week 72 (n=125)	88 8.5%
Week 84 (n=79)	84.8 8.2%
Week 96 (n=48)	91.7 8.9%
Week 108 (n=18)	100 9.7%
Week 120 (n=9)	100 9.7%
Week 132 (n=4)	100 9.7%
Week 144 (n=1)	100 9.7%

13. Secondary Outcome

Title	Percentage of Participants With ≥1.0 log10 Reduction From Baseline in HIV 1 RNA
Description	Defined as HIV-1 RNA levels < 400 copies/mL or at least 1.0 Log 10-decrease from baseline in HIV-1 RNA levels. Baseline value calculated as average of the screening and baseline values if both values were within 1 log10 difference.
Time Frame	Baseline up to Week 144

Outcome Measure Data

Analysis Population Description
Safety analysis set; n = number of participants contributing to summary statistic at given timepoint.

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
Measure Participants	1032
Day 2-7 (n=26)	30.8 3%
Week 2 (n=226)	90.3 8.8%
Week 4 (n=773)	90.2 8.7%
Week 8 (n=761)	91.2 8.8%
Week 12 (n=756)	91.3 8.8%
Week 16 (n=155)	82.6 8%
Week 20 (n=131)	89.3 8.7%
Week 24 (n=557)	89 8.6%
Week 32 (n=202)	90.1 8.7%
Week 40 (n=227)	87.7 8.5%
Week 48 (n=228)	86.4 8.4%
Week 60 (n=160)	85.6 8.3%
Week 72 (n=125)	83.2 8.1%
Week 84 (n=79)	79.7 7.7%
Week 96 (n=48)	85.4 8.3%
Week 108 (n=18)	100 9.7%
Week 120 (n=9)	100 9.7%
Week 132 (n=4)	100 9.7%
Week 144 (n=1)	100 9.7%

14. Secondary Outcome

Title	Percentage of Participants With HIV-1 RNA Levels Below the Limit of Quantification: <400 Copies/mL
Description	Limit of quantification defined as <400 copies/mL. Baseline value calculated as average of the screening and baseline values if both values were within 1 log 10 difference.
Time Frame	Baseline up to Week 144

Outcome Measure Data

Analysis Population Description
Safety analysis set; n = number of participants contributing to summary statistic at given timepoint.

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
Measure Participants	1032
Baseline (n=979)	6.7 0.6%
Day 2-7 (n=26)	3.8 0.4%
Week 2 (n=226)	58.8 5.7%
Week 4 (n=773)	72.7 7%
Week 8 (n=761)	78.8 7.6%
Week 12 (n=756)	82.5 8%
Week 16 (n=155)	75.5 7.3%
Week 20 (n=131)	83.2 8.1%
Week 24 (n=557)	84.4 8.2%
Week 32 (n=202)	83.7 8.1%
Week 40 (n=227)	81.1 7.9%
Week 48 (n=228)	80.7 7.8%
Week 60 (n=160)	78.1 7.6%
Week 72 (n=125)	72.8 7.1%
Week 84 (n=79)	74.7 7.2%
Week 96 (n=48)	75.0 7.3%
Week 108 (n=18)	88.9 8.6%
Week 120 (n=9)	77.8 7.5%
Week 132 (n=4)	100 9.7%
Week 144 (n=1)	100 9.7%

15. Secondary Outcome

Title	Percentage of Participants With HIV-1 RNA Levels Below the Limit of Quantification: <50 Copies/mL
Description	Limit of quantification defined as <50 copies/mL. Baseline value calculated as average of the screening and baseline values if both values were within 1 log 10 difference.
Time Frame	Baseline up to Week 144

Outcome Measure Data

Analysis Population Description
Safety analysis set; n = number of participants contributing to summary statistic at given timepoint.

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
Measure Participants	1032
Baseline (n=979)	1.7 0.2%
Day 2-7 (n=26)	0.0 0%
Week 2 (n=226)	19.9 1.9%
Week 4 (n=773)	30.1 2.9%
Week 8 (n=761)	43.1 4.2%
Week 12 (n=756)	45.8 4.4%
Week 16 (n=155)	37.4 3.6%
Week 20 (n=131)	42.7 4.1%
Week 24 (n=557)	55.8 5.4%
Week 32 (n=202)	57.4 5.6%
Week 40 (n=227)	54.6 5.3%
Week 48 (n=228)	54.8 5.3%
Week 60 (n=160)	51.9 5%
Week 72 (n=125)	49.6 4.8%
Week 84 (n=79)	55.7 5.4%
Week 96 (n=48)	54.2 5.3%
Week 108 (n=18)	77.8 7.5%
Week 120 (n=9)	44.4 4.3%
Week 132 (n=4)	75.0 7.3%
Week 144 (n=1)	100 9.7%

16. Secondary Outcome

Title	Change From Baseline in CD4 Cell Count
Description	Change from baseline in cluster of differentiation 4 helper T cells (CD4) cell count. If baseline value was not available, it was taken from immediate preceding non-missing value.
Time Frame	Baseline up to Week 144

Outcome Measure Data

Analysis Population Description
Safety analysis set; n = number of participants contributing to summary statistic at given timepoint.

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
Measure Participants	1032
Day 2-7 (n=6)	28.5 (76.18)
Week 2 (n=213)	49.7 (93.15)
Week 4 (n=762)	68.9 (124.31)
Week 8 (n=739)	94.5 (122.94)
Week 12 (n=738)	95.7 (124.42)
Week 16 (n=149)	85.9 (124.37)
Week 20 (n=130)	106.6 (112.26)
Week 24 (n=552)	127.8 (139.42)
Week 32 (n=197)	124.1 (150.44)
Week 40 (n=232)	129.2 (144.31)
Week 48 (n=222)	140.5 (154.46)
Week 60 (n=161)	134.0 (151.52)
Week 72 (n=124)	147.0 (160.92)
Week 84 (n=72)	141.1 (147.55)
Week 96 (n=50)	160.3 (160.78)
Week 108 (n=19)	242.9 (167.06)
Week 120 (n=8)	117.9 (203.49)
Week 132 (n=4)	179.0 (109.94)
Week 144 (n=1)	93.0 (NA)

17. Secondary Outcome

Title	Change From Baseline in CD4 Cell Count Percent
Description	Change from baseline in CD4 cell count percent . If baseline value was not available, it was taken from immediate preceding non-missing value.
Time Frame	Baseline up to Week 144

Outcome Measure Data

Analysis Population Description
Safety analysis set; n = number of participants contributing to summary statistic at given timepoint.

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
Measure Participants	1032
Days 2-7 (n=6)	-1.3 (1.56)
Week 2 (n=206)	1.8 (3.79)
Week 4 (n=733)	1.6 (4.84)
Week 8 (n=722)	1.4 (6.12)
Week 12 (n=708)	1.6 (5.45)
Week 16 (n=141)	1.9 (4.63)
Week 20 (n=125)	2.2 (6.17)
Week 24 (n=531)	2.8 (4.55)
Week 32 (n=191)	3.2 (5.38)
Week 40 (n=218)	3.7 (4.97)
Week 48 (n=210)	3.5 (5.87)
Week 60 (n=148)	4.5 (6.10)
Week 72 (n=116)	5.0 (6.33)
Week 84 (n=64)	5.7 (6.73)
Week 96 (n=41)	3.9 (6.36)
Week 108 (n=19)	6.3 (6.86)
Week 120 (n=7)	5.7 (9.07)
Week 132 (n=4)	8.5 (8.35)
Week 144 (n=1)	1.0 (0.0)

18. Secondary Outcome

Title	Change From Baseline in CD8 Cell Count
Description	Change from baseline in cluster of differentiation 8 suppressor T cells (CD8) cell count. If baseline value was not available, it was taken from immediate preceding non-missing value.
Time Frame	Baseline up to Week 144

Outcome Measure Data

Analysis Population Description
Safety analysis set; n = number of participants contributing to summary statistic at given timepoint.

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
Measure Participants	1032
Day 2-7 (n=6)	268.5 (262.50)
Week 2 (n=201)	78.2 (343.85)
Week 4 (n=701)	205.6 (509.70)
Week 8 (n=692)	345.6 (599.98)
Week 12 (n=696)	309.4 (578.91)
Week 16 (n=129)	259.6 (430.78)
Week 20 (n=119)	325.2 (621.46)
Week 24 (n=523)	251.3 (498.85)
Week 32 (n=185)	185.2 (484.74)
Week 40 (n=222)	160.9 (471.99)
Week 48 (n=214)	153.2 (464.73)
Week 60 (n=157)	76.9 (467.64)
Week 72 (n=120)	68.7 (502.73)
Week 84 (n=70)	-11.6 (548.85)
Week 96 (n=45)	56.6 (403.10)
Week 108 (n=19)	147.5 (600.55)
Week 120 (n=8)	-135.1 (517.02)
Week 132 (n=4)	-363.3 (882.30)
Week 144 (n=1)	642.0 (0.0)

19. Secondary Outcome

Title	Change From Baseline in CD8 Cell Count Percent
Description	Change from baseline in CD8 cell count percent . If baseline value was not available, it was taken from immediate preceding non-missing value.
Time Frame	Baseline up to Week 144

Outcome Measure Data

Analysis Population Description
Safety analysis set; n = number of participants contributing to summary statistic at given timepoint.

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
Measure Participants	1032
Day 2-7 (n=6)	3.0 (3.42)
Week 2 (n=197)	-1.5 (7.68)
Week 4 (n=689)	-0.3 (8.08)
Week 8 (n=683)	0.4 (9.62)
Week 12 (n=675)	-0.9 (9.95)
Week 16 (n=125)	0.7 (8.66)
Week 20 (n=115)	-0.7 (10.08)
Week 24 (n=510)	-3.2 (8.92)
Week 32 (n=184)	-4.0 (9.09)
Week 40 (n=215)	-4.5 (8.90)
Week 48 (n=202)	-5.1 (10.63)
Week 60 (n=146)	-5.0 (11.90)
Week 72 (n=113)	-6.2 (9.87)
Week 84 (n=64)	-8.2 (15.52)
Week 96 (n=40)	-9.5 (10.18)
Week 108 (n=19)	-14.5 (9.99)
Week 120 (n=6)	-14.5 (13.41)
Week 132 (n=4)	-16.8 (12.89)
Week 144 (n=1)	-2.0 (0.0)

20. Secondary Outcome

Title	Median Time to Virologic Failure
Description	Computed as time from the first dose of study medication to the loss of virologic response. Virologic failure defined as: failure to achieve a reduction from baseline (BL) in HIV 1 RNA ≥ 0.5 log10 copies /mL by the second viral load determination (unless viral load was below the lower limit level of quantification [LLOQ]); or a ≥ 0.5 log10 increase from nadir in HIV 1 RNA after achieving a HIV 1 RNA reduction from BL >0.5 log10 copies/mL; or a HIV 1 RNA level of >1000 copies/mL after having achieved a HIV 1 RNA level below LLOQ.
Time Frame	Day 1 up to Week 144

Outcome Measure Data

Analysis Population Description
Safety analysis set. N = number of participants with virologic failure. For the calculation of the time to virologic failure, any visits with no data were excluded. Participants who were not virologic failures were censored at the last available observation.

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
Measure Participants	192
Median (Inter-Quartile Range) [days]	86.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Maraviroc
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	75th percentile (median)
	Estimated Value	169.0
	Confidence Interval	(2-Sided) 95% 135.0 to 178.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Maraviroc
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	50th percentile (median)
	Estimated Value	86.5
	Confidence Interval	(2-Sided) 95% 82.0 to 92.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Maraviroc
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	25th percentile (median)
	Estimated Value	58.0
	Confidence Interval	(2-Sided) 95% 57.0 to 62.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

21. Secondary Outcome

Title	Percentage of Participants With Changes in HIV-1 RNA Level in Participants Meeting the Definition of Virologic Failure
Description	Reasons for virologic failure: A) failure to achieve a reduction in HIV-1 RNA>=0.5 log10 copies/ml from baseline (BL) by second viral load determination (unless below level of quantification [LOQ]); B) >=0.5 log10 increase from nadir in HIV-1 RNA after achieving an HIV-1 RNA reduction from BL >0.5 log10 copies/ml ; C) HIV-1 RNA >1000 copies/ml after having achieved an HIV-1 RNA below LOQ.
Time Frame	Baseline up to Week 144

Outcome Measure Data

Analysis Population Description
Safety analysis set; N = number of participants with virologic failure.

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
Measure Participants	192
Reduction in HIV-1 RNA<0.5 log10 copies/ml	43.75 4.2%
>=0.5 log10 increase from nadir in HIV-1 RNA	31.77 3.1%
HIV-1 RNA >1000 copies/ml	18.75 1.8%
Reduction <0.5 log10 + HIV-1 RNA >1000 copies/ml	3.13 0.3%
>=0.5 log10 increase from nadir + HIV-1 RNA >1000	2.60 0.3%

22. Secondary Outcome

Title	Percentage of Participants With Change in Chemokine Co-receptor Tropism From Screening to Time of Virologic Failure
Description	Tropism status (CCR5 [R5], CXCR4 [X4], Dual Mixed [DM], or Non-reportable [NR]) at Screening (Scr) and time of virologic failure (V fail). Virologic failure defined as: failure to achieve a reduction from baseline (BL) in HIV 1 RNA ≥0.5 log10 copies/mL by second viral load determination (unless viral load was below lower limit level of quantification [LLOQ]); or a ≥ 0.5 log10 increase from nadir in HIV 1 RNA after achieving HIV 1 RNA reduction from BL >0.5 log10 copies/mL; or a HIV 1 RNA level of >1000 copies/mL after having achieved a HIV 1 RNA level below LLOQ.
Time Frame	Screening up to Week 144

Outcome Measure Data

Analysis Population Description
Safety analysis set; N = participants with virologic failure (VF). Abbreviations: Scr = screening, R5 = CCR5 tropic HIV-1, X4=CXCR4 tropic HIV-1, DM = dual mixed, NR = non-reportable, Missing = participants with VF who did not have tropism result within specified screening period (Scr missing: -42 days to Day 0) or at the time of VF.

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
Measure Participants	192
Scr: Missing; V fail: R5	5.73 0.6%
Scr: Missing; V fail: X4	0.52 0.1%
Scr: Missing; V fail: DM	1.04 0.1%
Scr: Missing; V fail: NR	7.29 0.7%
Scr: Missing; V fail: Missing	1.56 0.2%
Scr: NR; V fail: R5	0.52 0.1%
Scr: R5; V fail: R5	31.25 3%
Scr: R5; V fail: X4	4.17 0.4%
Scr: R5; V fail: DM	18.75 1.8%
Scr: R5; V fail: NR	22.92 2.2%
Scr: R5; V fail: Missing	6.25 0.6%

23. Secondary Outcome

Title	Number of Participants With Reduced Maraviroc Susceptibility as Defined by Change From Baseline to Time of Virologic Failure in Inhibitory Concentration of 50% (IC 50) and Presence of Plateau
Description	Resistance to maravroc in viruses from participants failing therapy with R5 virus was investigated using the in vitro phenotypic (drug susceptibility) assay. The number of participants who failed with R5 virus were assessed successfully for maraviroc susceptibility at Baseline and Last on--treatment (Week 144). Samples were analyzed for change from Baseline to time of virologic failure in IC 50 and presence of plateau. A maximal percent inhibition (MPI) <95% established as a plateau in inhibition at high concentrations of maraviroc was used to identify viruses which had reduced phenotypic susceptibility to maraviroc.
Time Frame	Baseline up to Week 144

Outcome Measure Data

Analysis Population Description
Safety analysis set. Here, "number of participants analyzed" signifies those participants who were assessed for maraviroc susceptibility.

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
Measure Participants	26
Number [participants]	14 1.4%

24. Secondary Outcome

Title	Number of Participants With Emergence of Resistance to Maraviroc as Defined by Genotypic Changes in the V3 Loop of Glycoprotein 120 (gp 120)
Description	Virus from participants who experienced virologic failure was analyzed for resistance to maraviroc. Resistance testing was performed on archived samples of participants which were available pre--treatment at time of virologic failure. For participants who met definition of virologic failure during the trial, the sequencing of the V3 loop of HIV--1 viral envelope gp 120 was evaluated to identify any amino acid changes concomitant with decreased susceptibility to maraviroc.
Time Frame	Baseline up to Week 144

Outcome Measure Data

Analysis Population Description
Safety analysis set. Here, "number of participants analyzed" signifies those participants who were assessed for genotypic changes in the V3 Loop of glycoprotein 120 (gp 120).

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
Measure Participants	13
Number [participants]	NA NaN

Adverse Events

	Maraviroc
Time Frame
Adverse Event Reporting Description	The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
All Cause Mortality
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Maraviroc
	Affected / at Risk (%)	# Events
Total	139/1032 (13.5%)
Blood and lymphatic system disorders
Anaemia	5/1032 (0.5%)
Lymphadenopathy	1/1032 (0.1%)
Neutropenia	1/1032 (0.1%)
Thrombocytopenia	3/1032 (0.3%)
Cardiac disorders
Acute coronary syndrome	1/1032 (0.1%)
Angina unstable	1/1032 (0.1%)
Atrial fibrillation	1/1032 (0.1%)
Cardiac arrest	1/1032 (0.1%)
Congestive cardiomyopathy	1/1032 (0.1%)
Left ventricular failure	1/1032 (0.1%)
Myocardial infarction	3/1032 (0.3%)
Palpitations	1/1032 (0.1%)
Ventricular tachycardia	1/1032 (0.1%)
Ear and labyrinth disorders
Vertigo	2/1032 (0.2%)
Eye disorders
Vision blurred	1/1032 (0.1%)
Visual impairment	2/1032 (0.2%)
Vitreous floaters	1/1032 (0.1%)
Gastrointestinal disorders
Abdominal pain	3/1032 (0.3%)
Anal fissure	1/1032 (0.1%)
Anogenital dysplasia	1/1032 (0.1%)
Constipation	2/1032 (0.2%)
Diarrhoea	7/1032 (0.7%)
Food poisoning	1/1032 (0.1%)
Gastritis	1/1032 (0.1%)
Gastrointestinal haemorrhage	1/1032 (0.1%)
Inguinal hernia	1/1032 (0.1%)
Lower gastrointestinal haemorrhage	1/1032 (0.1%)
Mallory-Weiss syndrome	1/1032 (0.1%)
Nausea	3/1032 (0.3%)
Oesophagitis	1/1032 (0.1%)
Pancreatitis	1/1032 (0.1%)
Peptic ulcer	1/1032 (0.1%)
Rectal polyp	1/1032 (0.1%)
Umbilical hernia	1/1032 (0.1%)
Vomiting	2/1032 (0.2%)
General disorders
Chest pain	7/1032 (0.7%)
Chills	1/1032 (0.1%)
Drug interaction	1/1032 (0.1%)
Gait disturbance	1/1032 (0.1%)
General physical health deterioration	3/1032 (0.3%)
Hyperthermia	1/1032 (0.1%)
Pyrexia	10/1032 (1%)
Hepatobiliary disorders
Bile duct stone	1/1032 (0.1%)
Cytolytic hepatitis	4/1032 (0.4%)
Hepatic failure	1/1032 (0.1%)
Hepatitis cholestatic	1/1032 (0.1%)
Hepatotoxicity	1/1032 (0.1%)
Hypertransaminasaemia	2/1032 (0.2%)
Immune system disorders
Immune reconstitution syndrome	1/1032 (0.1%)
Infections and infestations
AIDS encephalopathy	1/1032 (0.1%)
Bacteraemia	2/1032 (0.2%)
Bone tuberculosis	1/1032 (0.1%)
Bronchitis fungal	1/1032 (0.1%)
Cellulitis	1/1032 (0.1%)
Clostridium difficile colitis	1/1032 (0.1%)
Dengue fever	1/1032 (0.1%)
Dermo-hypodermitis	1/1032 (0.1%)
Dysentery	1/1032 (0.1%)
Ear infection	1/1032 (0.1%)
Erysipelas	2/1032 (0.2%)
Extradural abscess	1/1032 (0.1%)
Gastroenteritis	1/1032 (0.1%)
HIV infection	1/1032 (0.1%)
Hepatitis B	2/1032 (0.2%)
Herpes zoster	3/1032 (0.3%)
Influenza	1/1032 (0.1%)
Intervertebral discitis	1/1032 (0.1%)
Leptospirosis	1/1032 (0.1%)
Lower respiratory tract infection bacterial	1/1032 (0.1%)
Mastoiditis	1/1032 (0.1%)
Meningitis cryptococcal	1/1032 (0.1%)
Meningitis tuberculous	1/1032 (0.1%)
Mycobacterium avium complex infection	1/1032 (0.1%)
Mycobacterium kansasii infection	1/1032 (0.1%)
Pancreatitis bacterial	1/1032 (0.1%)
Pneumococcal sepsis	1/1032 (0.1%)
Pneumocystis jiroveci pneumonia	1/1032 (0.1%)
Pneumonia	11/1032 (1.1%)
Pneumonia bacterial	2/1032 (0.2%)
Pneumonia legionella	2/1032 (0.2%)
Pseudomonas infection	1/1032 (0.1%)
Pulmonary tuberculosis	3/1032 (0.3%)
Respiratory tract infection	1/1032 (0.1%)
Respiratory tract infection bacterial	1/1032 (0.1%)
Sepsis	2/1032 (0.2%)
Septic shock	1/1032 (0.1%)
Sinusitis	2/1032 (0.2%)
Staphylococcal bacteraemia	1/1032 (0.1%)
Upper respiratory tract infection	1/1032 (0.1%)
Urinary tract infection	4/1032 (0.4%)
Injury, poisoning and procedural complications
Ankle fracture	1/1032 (0.1%)
Drug toxicity	3/1032 (0.3%)
Femur fracture	1/1032 (0.1%)
Joint injury	1/1032 (0.1%)
Overdose	1/1032 (0.1%)
Post lumbar puncture syndrome	1/1032 (0.1%)
Radius fracture	1/1032 (0.1%)
Rib fracture	1/1032 (0.1%)
Investigations
Blood alkaline phosphatase increased	2/1032 (0.2%)
Blood creatine phosphokinase increased	2/1032 (0.2%)
Blood glucose increased	1/1032 (0.1%)
Clostridium test positive	1/1032 (0.1%)
Hepatic enzyme increased	1/1032 (0.1%)
Weight decreased	2/1032 (0.2%)
Metabolism and nutrition disorders
Dehydration	2/1032 (0.2%)
Diabetic foot	1/1032 (0.1%)
Hypoglycaemia	1/1032 (0.1%)
Hypokalaemia	3/1032 (0.3%)
Hyponatraemia	1/1032 (0.1%)
Lactic acidosis	1/1032 (0.1%)
Musculoskeletal and connective tissue disorders
Arthralgia	2/1032 (0.2%)
Bone pain	1/1032 (0.1%)
Myalgia	1/1032 (0.1%)
Polyarthritis	1/1032 (0.1%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal cancer	3/1032 (0.3%)
B-cell lymphoma	1/1032 (0.1%)
Basal cell carcinoma	1/1032 (0.1%)
Carcinoma in situ of penis	2/1032 (0.2%)
Gastric cancer	1/1032 (0.1%)
Hodgkin's disease	1/1032 (0.1%)
Prostate cancer	1/1032 (0.1%)
Rectal cancer	2/1032 (0.2%)
Nervous system disorders
Brain oedema	1/1032 (0.1%)
Convulsion	3/1032 (0.3%)
Disturbance in attention	1/1032 (0.1%)
Dizziness	1/1032 (0.1%)
Encephalopathy	1/1032 (0.1%)
Headache	1/1032 (0.1%)
Paraesthesia	1/1032 (0.1%)
Presyncope	1/1032 (0.1%)
Syncope	1/1032 (0.1%)
Transient ischaemic attack	1/1032 (0.1%)
Psychiatric disorders
Anxiety disorder	1/1032 (0.1%)
Completed suicide	1/1032 (0.1%)
Depression	2/1032 (0.2%)
Hallucination, auditory	1/1032 (0.1%)
Homicidal ideation	1/1032 (0.1%)
Major depression	1/1032 (0.1%)
Suicidal ideation	1/1032 (0.1%)
Suicide attempt	2/1032 (0.2%)
Renal and urinary disorders
Renal failure	3/1032 (0.3%)
Renal failure acute	4/1032 (0.4%)
Urinary bladder polyp	1/1032 (0.1%)
Urinary retention	1/1032 (0.1%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure	1/1032 (0.1%)
Chronic obstructive pulmonary disease	1/1032 (0.1%)
Cough	2/1032 (0.2%)
Dyspnoea	5/1032 (0.5%)
Hypoxia	2/1032 (0.2%)
Lung disorder	1/1032 (0.1%)
Pulmonary oedema	1/1032 (0.1%)
Skin and subcutaneous tissue disorders
Dermatitis allergic	1/1032 (0.1%)
Lichenoid keratosis	1/1032 (0.1%)
Psoriasis	1/1032 (0.1%)
Rash	2/1032 (0.2%)
Stevens-Johnson syndrome	1/1032 (0.1%)
Surgical and medical procedures
Coronary artery bypass	1/1032 (0.1%)
Vascular disorders
Hypertension	2/1032 (0.2%)
Hypertensive crisis	2/1032 (0.2%)
Orthostatic hypotension	2/1032 (0.2%)
Other (Not Including Serious) Adverse Events
	Maraviroc
	Affected / at Risk (%)	# Events
Total	700/1032 (67.8%)
Blood and lymphatic system disorders
Agranulocytosis	1/1032 (0.1%)
Anaemia	18/1032 (1.7%)
Bone marrow failure	1/1032 (0.1%)
Eosinophilia	2/1032 (0.2%)
Iron deficiency anaemia	1/1032 (0.1%)
Leukocytosis	2/1032 (0.2%)
Leukopenia	2/1032 (0.2%)
Lymphadenopathy	18/1032 (1.7%)
Microcytic anaemia	2/1032 (0.2%)
Microcytosis	1/1032 (0.1%)
Neutropenia	2/1032 (0.2%)
Polycythaemia	1/1032 (0.1%)
Splenomegaly	3/1032 (0.3%)
Thrombocytopenia	2/1032 (0.2%)
Cardiac disorders
Angina pectoris	3/1032 (0.3%)
Cardiac failure congestive	2/1032 (0.2%)
Cyanosis	1/1032 (0.1%)
Extrasystoles	1/1032 (0.1%)
Hyperdynamic left ventricle	1/1032 (0.1%)
Left atrial dilatation	1/1032 (0.1%)
Palpitations	3/1032 (0.3%)
Pericardial effusion	1/1032 (0.1%)
Sinus bradycardia	1/1032 (0.1%)
Tachycardia	5/1032 (0.5%)
Congenital, familial and genetic disorders
Accessory spleen	1/1032 (0.1%)
Dysmorphism	1/1032 (0.1%)
Preauricular cyst	1/1032 (0.1%)
Ear and labyrinth disorders
Cerumen impaction	1/1032 (0.1%)
Ear pain	7/1032 (0.7%)
Tinnitus	4/1032 (0.4%)
Tympanic membrane hyperaemia	1/1032 (0.1%)
Vertigo	12/1032 (1.2%)
Endocrine disorders
Goitre	2/1032 (0.2%)
Hypogonadism	1/1032 (0.1%)
Hypothyroidism	1/1032 (0.1%)
Inappropriate antidiuretic hormone secretion	1/1032 (0.1%)
Eye disorders
Blepharitis	3/1032 (0.3%)
Blindness unilateral	1/1032 (0.1%)
Cataract	1/1032 (0.1%)
Conjunctival haemorrhage	1/1032 (0.1%)
Conjunctivitis	10/1032 (1%)
Conjunctivitis allergic	2/1032 (0.2%)
Dry eye	1/1032 (0.1%)
Exophthalmos	1/1032 (0.1%)
Eye irritation	2/1032 (0.2%)
Eye swelling	1/1032 (0.1%)
Foreign body sensation in eyes	1/1032 (0.1%)
Glaucoma	1/1032 (0.1%)
Metamorphopsia	1/1032 (0.1%)
Ocular icterus	1/1032 (0.1%)
Punctate keratitis	1/1032 (0.1%)
Pupils unequal	1/1032 (0.1%)
Uveitis	1/1032 (0.1%)
Vision blurred	7/1032 (0.7%)
Visual acuity reduced	3/1032 (0.3%)
Visual impairment	5/1032 (0.5%)
Vitreous detachment	1/1032 (0.1%)
Vitreous floaters	1/1032 (0.1%)
Gastrointestinal disorders
Abdominal discomfort	2/1032 (0.2%)
Abdominal distension	12/1032 (1.2%)
Abdominal pain	20/1032 (1.9%)
Abdominal pain lower	1/1032 (0.1%)
Abdominal pain upper	14/1032 (1.4%)
Abdominal tenderness	1/1032 (0.1%)
Anal fistula	1/1032 (0.1%)
Anal polyp	1/1032 (0.1%)
Anal ulcer	1/1032 (0.1%)
Anogenital dysplasia	1/1032 (0.1%)
Anorectal discomfort	1/1032 (0.1%)
Anorectal disorder	4/1032 (0.4%)
Aphthous stomatitis	5/1032 (0.5%)
Cheilitis	5/1032 (0.5%)
Colitis	2/1032 (0.2%)
Colitis ulcerative	1/1032 (0.1%)
Colonic polyp	1/1032 (0.1%)
Constipation	35/1032 (3.4%)
Defaecation urgency	1/1032 (0.1%)
Dental caries	3/1032 (0.3%)
Diarrhoea	94/1032 (9.1%)
Diarrhoea haemorrhagic	1/1032 (0.1%)
Dry mouth	6/1032 (0.6%)
Dyspepsia	13/1032 (1.3%)
Dysphagia	6/1032 (0.6%)
Eructation	1/1032 (0.1%)
Faecal incontinence	1/1032 (0.1%)
Flatulence	14/1032 (1.4%)
Food poisoning	1/1032 (0.1%)
Gastric disorder	1/1032 (0.1%)
Gastritis	10/1032 (1%)
Gastrointestinal disorder	5/1032 (0.5%)
Gastrointestinal pain	1/1032 (0.1%)
Gastrooesophageal reflux disease	9/1032 (0.9%)
Gingivitis	5/1032 (0.5%)
Glossitis	2/1032 (0.2%)
Haematochezia	1/1032 (0.1%)
Haemorrhoidal haemorrhage	2/1032 (0.2%)
Haemorrhoids	13/1032 (1.3%)
Hyperchlorhydria	1/1032 (0.1%)
Hypoaesthesia oral	1/1032 (0.1%)
Inguinal hernia	1/1032 (0.1%)
Intestinal obstruction	1/1032 (0.1%)
Irritable bowel syndrome	1/1032 (0.1%)
Mouth ulceration	2/1032 (0.2%)
Nausea	60/1032 (5.8%)
Odynophagia	3/1032 (0.3%)
Oesophagitis	3/1032 (0.3%)
Oral discomfort	1/1032 (0.1%)
Oral disorder	1/1032 (0.1%)
Oral lichen planus	1/1032 (0.1%)
Painful defaecation	2/1032 (0.2%)
Paraesthesia oral	1/1032 (0.1%)
Parotid gland enlargement	2/1032 (0.2%)
Periodontitis	1/1032 (0.1%)
Proctalgia	1/1032 (0.1%)
Rectal haemorrhage	6/1032 (0.6%)
Salivary gland cyst	1/1032 (0.1%)
Tongue discolouration	1/1032 (0.1%)
Tongue disorder	1/1032 (0.1%)
Tongue ulceration	1/1032 (0.1%)
Toothache	2/1032 (0.2%)
Umbilical hernia	2/1032 (0.2%)
Uvulitis	1/1032 (0.1%)
Vomiting	34/1032 (3.3%)
General disorders
Adverse drug reaction	1/1032 (0.1%)
Asthenia	21/1032 (2%)
Chest discomfort	1/1032 (0.1%)
Chest pain	9/1032 (0.9%)
Chills	5/1032 (0.5%)
Crepitations	1/1032 (0.1%)
Facial pain	1/1032 (0.1%)
Fat tissue increased	1/1032 (0.1%)
Fatigue	24/1032 (2.3%)
Feeling hot	1/1032 (0.1%)
Feeling jittery	1/1032 (0.1%)
Influenza like illness	14/1032 (1.4%)
Injection site nodule	1/1032 (0.1%)
Injection site reaction	8/1032 (0.8%)
Injection site swelling	1/1032 (0.1%)
Irritability	1/1032 (0.1%)
Local swelling	2/1032 (0.2%)
Malaise	4/1032 (0.4%)
Mucosal inflammation	1/1032 (0.1%)
Necrosis	1/1032 (0.1%)
Nodule	3/1032 (0.3%)
Oedema	3/1032 (0.3%)
Oedema peripheral	12/1032 (1.2%)
Pain	15/1032 (1.5%)
Pyrexia	50/1032 (4.8%)
Thirst	1/1032 (0.1%)
Ulcer	3/1032 (0.3%)
Hepatobiliary disorders
Cholelithiasis	1/1032 (0.1%)
Cholestasis	1/1032 (0.1%)
Cytolytic hepatitis	7/1032 (0.7%)
Hepatic steatosis	2/1032 (0.2%)
Hepatitis acute	1/1032 (0.1%)
Hepatomegaly	8/1032 (0.8%)
Hyperbilirubinaemia	1/1032 (0.1%)
Hypertransaminasaemia	1/1032 (0.1%)
Jaundice	4/1032 (0.4%)
Liver disorder	2/1032 (0.2%)
Immune system disorders
Allergy to arthropod bite	1/1032 (0.1%)
Drug hypersensitivity	3/1032 (0.3%)
Food allergy	1/1032 (0.1%)
Hypersensitivity	2/1032 (0.2%)
Immune reconstitution syndrome	3/1032 (0.3%)
Seasonal allergy	1/1032 (0.1%)
Infections and infestations
Abscess	1/1032 (0.1%)
Abscess limb	1/1032 (0.1%)
Acarodermatitis	2/1032 (0.2%)
Acute sinusitis	2/1032 (0.2%)
Amoebic dysentery	1/1032 (0.1%)
Anal abscess	2/1032 (0.2%)
Anal fungal infection	1/1032 (0.1%)
Anogenital warts	6/1032 (0.6%)
Body tinea	2/1032 (0.2%)
Bronchiolitis	1/1032 (0.1%)
Bronchitis	67/1032 (6.5%)
Bronchitis bacterial	1/1032 (0.1%)
Campylobacter intestinal infection	1/1032 (0.1%)
Candidiasis	5/1032 (0.5%)
Cellulitis	8/1032 (0.8%)
Chronic sinusitis	3/1032 (0.3%)
Conjunctivitis viral	1/1032 (0.1%)
Cystitis	5/1032 (0.5%)
Cytomegalovirus infection	2/1032 (0.2%)
Dermo-hypodermitis	1/1032 (0.1%)
Diverticulitis	1/1032 (0.1%)
Ear infection	5/1032 (0.5%)
Extrapulmonary tuberculosis	1/1032 (0.1%)
Eye infection	1/1032 (0.1%)
Folliculitis	6/1032 (0.6%)
Fungal infection	3/1032 (0.3%)
Fungal skin infection	5/1032 (0.5%)
Furuncle	3/1032 (0.3%)
Gastroenteritis	17/1032 (1.6%)
Gastroenteritis viral	2/1032 (0.2%)
Gastrointestinal infection	4/1032 (0.4%)
Gastrointestinal viral infection	1/1032 (0.1%)
Genital abscess	1/1032 (0.1%)
Genital herpes	12/1032 (1.2%)
Genital infection fungal	3/1032 (0.3%)
Genitourinary chlamydia infection	1/1032 (0.1%)
Gingival infection	1/1032 (0.1%)
Gonorrhoea	1/1032 (0.1%)
Haematoma infection	1/1032 (0.1%)
Haemophilus infection	1/1032 (0.1%)
Helicobacter gastritis	2/1032 (0.2%)
Hepatitis A	1/1032 (0.1%)
Hepatitis B	3/1032 (0.3%)
Hepatitis C	6/1032 (0.6%)
Herpes simplex	14/1032 (1.4%)
Herpes virus infection	10/1032 (1%)
Herpes zoster	18/1032 (1.7%)
Hordeolum	1/1032 (0.1%)
Impetigo	2/1032 (0.2%)
Infected bites	1/1032 (0.1%)
Infection	3/1032 (0.3%)
Infestation	1/1032 (0.1%)
Influenza	29/1032 (2.8%)
Laryngitis	1/1032 (0.1%)
Localised infection	1/1032 (0.1%)
Lower respiratory tract infection	5/1032 (0.5%)
Lymphangitis	1/1032 (0.1%)
Mastitis	1/1032 (0.1%)
Mastoiditis	1/1032 (0.1%)
Meningitis aseptic	1/1032 (0.1%)
Molluscum contagiosum	2/1032 (0.2%)
Mycotic corneal ulcer	1/1032 (0.1%)
Nasopharyngitis	41/1032 (4%)
Oesophageal candidiasis	6/1032 (0.6%)
Onychomycosis	6/1032 (0.6%)
Oral candidiasis	28/1032 (2.7%)
Oral fungal infection	3/1032 (0.3%)
Oral hairy leukoplakia	3/1032 (0.3%)
Oral herpes	13/1032 (1.3%)
Oral infection	1/1032 (0.1%)
Orchitis	2/1032 (0.2%)
Otitis externa	3/1032 (0.3%)
Otitis media	7/1032 (0.7%)
Otitis media acute	1/1032 (0.1%)
Papilloma viral infection	4/1032 (0.4%)
Paronychia	2/1032 (0.2%)
Pharyngitis	22/1032 (2.1%)
Pneumococcal infection	1/1032 (0.1%)
Pneumonia	6/1032 (0.6%)
Progressive multifocal leukoencephalopathy	1/1032 (0.1%)
Prostatitis Escherichia coli	1/1032 (0.1%)
Pulmonary tuberculosis	2/1032 (0.2%)
Purulent discharge	1/1032 (0.1%)
Pyelonephritis	2/1032 (0.2%)
Rash pustular	1/1032 (0.1%)
Respiratory tract infection	5/1032 (0.5%)
Respiratory tract infection viral	2/1032 (0.2%)
Rhinitis	13/1032 (1.3%)
Scrotal infection	1/1032 (0.1%)
Secondary syphilis	1/1032 (0.1%)
Sepsis	1/1032 (0.1%)
Shigella infection	1/1032 (0.1%)
Sinusitis	28/1032 (2.7%)
Skin infection	3/1032 (0.3%)
Staphylococcal infection	3/1032 (0.3%)
Staphylococcal skin infection	1/1032 (0.1%)
Syphilis	7/1032 (0.7%)
Tinea cruris	3/1032 (0.3%)
Tinea infection	3/1032 (0.3%)
Tinea pedis	5/1032 (0.5%)
Tinea versicolour	2/1032 (0.2%)
Tooth abscess	3/1032 (0.3%)
Tooth infection	4/1032 (0.4%)
Toxoplasmosis	1/1032 (0.1%)
Tracheitis	1/1032 (0.1%)
Upper respiratory tract infection	41/1032 (4%)
Urethritis	2/1032 (0.2%)
Urethritis gonococcal	1/1032 (0.1%)
Urinary tract infection	17/1032 (1.6%)
Urinary tract infection bacterial	1/1032 (0.1%)
Urinary tract infection enterococcal	1/1032 (0.1%)
Urinary tract infection fungal	1/1032 (0.1%)
Viral infection	6/1032 (0.6%)
Viral pharyngitis	1/1032 (0.1%)
Viral sinusitis	1/1032 (0.1%)
Viral upper respiratory tract infection	2/1032 (0.2%)
Vulvovaginal candidiasis	4/1032 (0.4%)
Wound infection	1/1032 (0.1%)
Injury, poisoning and procedural complications
Animal bite	1/1032 (0.1%)
Ankle fracture	1/1032 (0.1%)
Arthropod bite	3/1032 (0.3%)
Bone fissure	1/1032 (0.1%)
Clavicle fracture	1/1032 (0.1%)
Contusion	3/1032 (0.3%)
Epicondylitis	2/1032 (0.2%)
Excoriation	1/1032 (0.1%)
Fall	3/1032 (0.3%)
Foot fracture	3/1032 (0.3%)
Foreign body in eye	1/1032 (0.1%)
Head injury	1/1032 (0.1%)
Joint injury	3/1032 (0.3%)
Joint sprain	4/1032 (0.4%)
Ligament rupture	1/1032 (0.1%)
Ligament sprain	1/1032 (0.1%)
Limb injury	2/1032 (0.2%)
Muscle strain	3/1032 (0.3%)
Overdose	2/1032 (0.2%)
Periorbital haematoma	1/1032 (0.1%)
Radius fracture	1/1032 (0.1%)
Skeletal injury	1/1032 (0.1%)
Skin laceration	2/1032 (0.2%)
Sunburn	1/1032 (0.1%)
Thermal burn	1/1032 (0.1%)
Upper limb fracture	2/1032 (0.2%)
Investigations
Alanine aminotransferase increased	13/1032 (1.3%)
Aspartate aminotransferase abnormal	1/1032 (0.1%)
Aspartate aminotransferase increased	9/1032 (0.9%)
Blood alkaline phosphatase	1/1032 (0.1%)
Blood amylase increased	11/1032 (1.1%)
Blood cholesterol increased	2/1032 (0.2%)
Blood creatine increased	1/1032 (0.1%)
Blood creatine phosphokinase increased	8/1032 (0.8%)
Blood creatinine increased	4/1032 (0.4%)
Blood glucose abnormal	1/1032 (0.1%)
Blood glucose increased	4/1032 (0.4%)
Blood iron decreased	1/1032 (0.1%)
Blood lactate dehydrogenase increased	1/1032 (0.1%)
Blood phosphorus decreased	1/1032 (0.1%)
Blood pressure increased	2/1032 (0.2%)
Blood sodium increased	1/1032 (0.1%)
Blood triglycerides increased	6/1032 (0.6%)
Blood uric acid increased	6/1032 (0.6%)
Blood urine present	1/1032 (0.1%)
Body temperature increased	1/1032 (0.1%)
Cardiac function test abnormal	1/1032 (0.1%)
Cardiac murmur	3/1032 (0.3%)
Carotid bruit	1/1032 (0.1%)
Eosinophil count increased	1/1032 (0.1%)
Gamma-glutamyltransferase increased	12/1032 (1.2%)
Glycosylated haemoglobin increased	1/1032 (0.1%)
Haemoglobin decreased	2/1032 (0.2%)
Helicobacter test positive	1/1032 (0.1%)
Hepatic enzyme increased	2/1032 (0.2%)
Hepatitis B DNA increased	1/1032 (0.1%)
Hepatitis B antibody positive	1/1032 (0.1%)
Hepatitis B positive	1/1032 (0.1%)
Hepatitis B surface antigen positive	3/1032 (0.3%)
Lipase increased	7/1032 (0.7%)
Liver function test abnormal	2/1032 (0.2%)
Low density lipoprotein increased	1/1032 (0.1%)
Lymph node palpable	2/1032 (0.2%)
Murphy's sign positive	1/1032 (0.1%)
Occult blood positive	1/1032 (0.1%)
Physical examination	2/1032 (0.2%)
Platelet count decreased	2/1032 (0.2%)
Prostatic specific antigen increased	1/1032 (0.1%)
Serum ferritin increased	1/1032 (0.1%)
Transaminases increased	6/1032 (0.6%)
Treponema test positive	1/1032 (0.1%)
Urine output decreased	1/1032 (0.1%)
Waist circumference increased	1/1032 (0.1%)
Weight decreased	12/1032 (1.2%)
Weight increased	11/1032 (1.1%)
Metabolism and nutrition disorders
Cell death	2/1032 (0.2%)
Decreased appetite	9/1032 (0.9%)
Dehydration	2/1032 (0.2%)
Diabetes mellitus	2/1032 (0.2%)
Dyslipidaemia	2/1032 (0.2%)
Folate deficiency	1/1032 (0.1%)
Gout	2/1032 (0.2%)
Hyperamylasaemia	1/1032 (0.1%)
Hypercalcaemia	1/1032 (0.1%)
Hypercholesterolaemia	4/1032 (0.4%)
Hyperglycaemia	3/1032 (0.3%)
Hyperkalaemia	1/1032 (0.1%)
Hyperlipidaemia	6/1032 (0.6%)
Hypertriglyceridaemia	25/1032 (2.4%)
Hyperuricaemia	2/1032 (0.2%)
Hypocalcaemia	2/1032 (0.2%)
Hypocholesterolaemia	1/1032 (0.1%)
Hypoglycaemia	2/1032 (0.2%)
Hypokalaemia	6/1032 (0.6%)
Hypovolaemia	1/1032 (0.1%)
Impaired fasting glucose	2/1032 (0.2%)
Increased appetite	2/1032 (0.2%)
Malnutrition	2/1032 (0.2%)
Metabolic syndrome	1/1032 (0.1%)
Selenium deficiency	1/1032 (0.1%)
Type 2 diabetes mellitus	2/1032 (0.2%)
Vitamin C deficiency	1/1032 (0.1%)
Vitamin D deficiency	2/1032 (0.2%)
Zinc deficiency	1/1032 (0.1%)
Musculoskeletal and connective tissue disorders
Arthralgia	34/1032 (3.3%)
Arthritis	3/1032 (0.3%)
Arthropathy	1/1032 (0.1%)
Back pain	45/1032 (4.4%)
Bone disorder	1/1032 (0.1%)
Bone pain	2/1032 (0.2%)
Bursa disorder	1/1032 (0.1%)
Bursitis	1/1032 (0.1%)
Coccydynia	1/1032 (0.1%)
Costochondritis	1/1032 (0.1%)
Enthesopathy	1/1032 (0.1%)
Flank pain	3/1032 (0.3%)
Gouty arthritis	1/1032 (0.1%)
Groin pain	1/1032 (0.1%)
Hypercreatinaemia	1/1032 (0.1%)
Intervertebral disc protrusion	3/1032 (0.3%)
Joint range of motion decreased	1/1032 (0.1%)
Joint stiffness	1/1032 (0.1%)
Joint swelling	1/1032 (0.1%)
Limb discomfort	1/1032 (0.1%)
Muscle atrophy	1/1032 (0.1%)
Muscle contracture	1/1032 (0.1%)
Muscle spasms	6/1032 (0.6%)
Musculoskeletal chest pain	3/1032 (0.3%)
Musculoskeletal pain	11/1032 (1.1%)
Musculoskeletal stiffness	1/1032 (0.1%)
Myalgia	20/1032 (1.9%)
Neck pain	6/1032 (0.6%)
Nodule on extremity	1/1032 (0.1%)
Osteitis	1/1032 (0.1%)
Osteoarthritis	2/1032 (0.2%)
Osteonecrosis	1/1032 (0.1%)
Osteopenia	1/1032 (0.1%)
Pain in extremity	20/1032 (1.9%)
Plantar fasciitis	1/1032 (0.1%)
Polyarthritis	1/1032 (0.1%)
Rotator cuff syndrome	2/1032 (0.2%)
Synovial cyst	1/1032 (0.1%)
Tendon pain	2/1032 (0.2%)
Tendonitis	4/1032 (0.4%)
Tenosynovitis	1/1032 (0.1%)
Torticollis	1/1032 (0.1%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma	1/1032 (0.1%)
Bowen's disease	1/1032 (0.1%)
Haemangioma	1/1032 (0.1%)
Kaposi's sarcoma	2/1032 (0.2%)
Lipoma	1/1032 (0.1%)
Oral papilloma	4/1032 (0.4%)
Penile wart	2/1032 (0.2%)
Prostatic adenoma	1/1032 (0.1%)
Rectal cancer	1/1032 (0.1%)
Seborrhoeic keratosis	2/1032 (0.2%)
Skin papilloma	9/1032 (0.9%)
Squamous cell carcinoma	1/1032 (0.1%)
Testicular neoplasm	1/1032 (0.1%)
Thyroid neoplasm	1/1032 (0.1%)
Tongue neoplasm malignant stage unspecified	1/1032 (0.1%)
Uterine leiomyoma	1/1032 (0.1%)
Nervous system disorders
Ageusia	1/1032 (0.1%)
Amnesia	4/1032 (0.4%)
Aphasia	1/1032 (0.1%)
Ataxia	1/1032 (0.1%)
Carpal tunnel syndrome	1/1032 (0.1%)
Central nervous system lesion	1/1032 (0.1%)
Cerebral atrophy	1/1032 (0.1%)
Decreased vibratory sense	1/1032 (0.1%)
Dizziness	26/1032 (2.5%)
Dysaesthesia	2/1032 (0.2%)
Dysarthria	1/1032 (0.1%)
Epilepsy	1/1032 (0.1%)
Facial palsy	2/1032 (0.2%)
Headache	66/1032 (6.4%)
Hyperaesthesia	1/1032 (0.1%)
Hypersomnia	1/1032 (0.1%)
Hypoaesthesia	1/1032 (0.1%)
Lethargy	1/1032 (0.1%)
Loss of consciousness	2/1032 (0.2%)
Memory impairment	3/1032 (0.3%)
Migraine	3/1032 (0.3%)
Muscle contractions involuntary	2/1032 (0.2%)
Nerve root compression	1/1032 (0.1%)
Neuralgia	2/1032 (0.2%)
Neuropathy peripheral	14/1032 (1.4%)
Paraesthesia	6/1032 (0.6%)
Presyncope	1/1032 (0.1%)
Radiculopathy	1/1032 (0.1%)
Sciatica	6/1032 (0.6%)
Sensory disturbance	1/1032 (0.1%)
Serotonin syndrome	1/1032 (0.1%)
Sleep phase rhythm disturbance	1/1032 (0.1%)
Somnolence	3/1032 (0.3%)
Syncope	1/1032 (0.1%)
Tension headache	1/1032 (0.1%)
Psychiatric disorders
Abnormal dreams	4/1032 (0.4%)
Aggression	1/1032 (0.1%)
Agitation	3/1032 (0.3%)
Anxiety	23/1032 (2.2%)
Bipolar I disorder	1/1032 (0.1%)
Bulimia nervosa	1/1032 (0.1%)
Confusional state	3/1032 (0.3%)
Depressed mood	2/1032 (0.2%)
Depression	20/1032 (1.9%)
Disorientation	1/1032 (0.1%)
Dysphoria	1/1032 (0.1%)
Euphoric mood	1/1032 (0.1%)
Hallucination	1/1032 (0.1%)
Hallucination, auditory	1/1032 (0.1%)
Initial insomnia	1/1032 (0.1%)
Insomnia	32/1032 (3.1%)
Libido decreased	3/1032 (0.3%)
Libido disorder	1/1032 (0.1%)
Mental disorder	1/1032 (0.1%)
Mood altered	1/1032 (0.1%)
Nervousness	2/1032 (0.2%)
Sleep disorder	4/1032 (0.4%)
Stereotypy	1/1032 (0.1%)
Stress	2/1032 (0.2%)
Thinking abnormal	1/1032 (0.1%)
Tic	1/1032 (0.1%)
Withdrawal syndrome	1/1032 (0.1%)
Renal and urinary disorders
Bladder disorder	1/1032 (0.1%)
Calculus bladder	1/1032 (0.1%)
Calculus ureteric	1/1032 (0.1%)
Chromaturia	1/1032 (0.1%)
Dysuria	9/1032 (0.9%)
Haematuria	4/1032 (0.4%)
Microalbuminuria	1/1032 (0.1%)
Micturition disorder	1/1032 (0.1%)
Micturition urgency	1/1032 (0.1%)
Nephritis	1/1032 (0.1%)
Nephroangiosclerosis	1/1032 (0.1%)
Nephrolithiasis	3/1032 (0.3%)
Nephropathy	1/1032 (0.1%)
Nocturia	2/1032 (0.2%)
Pollakiuria	5/1032 (0.5%)
Polyuria	3/1032 (0.3%)
Pyuria	1/1032 (0.1%)
Renal cyst	1/1032 (0.1%)
Renal failure	4/1032 (0.4%)
Renal failure acute	2/1032 (0.2%)
Renal impairment	1/1032 (0.1%)
Renal pain	1/1032 (0.1%)
Ureteral disorder	1/1032 (0.1%)
Urinary hesitation	3/1032 (0.3%)
Urinary incontinence	3/1032 (0.3%)
Urinary tract disorder	1/1032 (0.1%)
Reproductive system and breast disorders
Amenorrhoea	2/1032 (0.2%)
Balanitis	2/1032 (0.2%)
Bartholin's cyst	1/1032 (0.1%)
Benign prostatic hyperplasia	2/1032 (0.2%)
Breast cyst	1/1032 (0.1%)
Breast pain	2/1032 (0.2%)
Cervical polyp	1/1032 (0.1%)
Erectile dysfunction	10/1032 (1%)
Galactorrhoea	1/1032 (0.1%)
Genital lesion	1/1032 (0.1%)
Genital ulceration	1/1032 (0.1%)
Gynaecomastia	3/1032 (0.3%)
Metrorrhagia	1/1032 (0.1%)
Oedema genital	1/1032 (0.1%)
Ovarian cyst	1/1032 (0.1%)
Pelvic pain	2/1032 (0.2%)
Premenstrual syndrome	1/1032 (0.1%)
Prostatic pain	1/1032 (0.1%)
Prostatism	2/1032 (0.2%)
Prostatitis	7/1032 (0.7%)
Pruritus genital	1/1032 (0.1%)
Retrograde ejaculation	1/1032 (0.1%)
Scrotal ulcer	1/1032 (0.1%)
Testicular pain	1/1032 (0.1%)
Testicular swelling	2/1032 (0.2%)
Uterine cyst	1/1032 (0.1%)
Vaginal discharge	1/1032 (0.1%)
Vulvovaginal discomfort	1/1032 (0.1%)
Respiratory, thoracic and mediastinal disorders
Asthma	6/1032 (0.6%)
Asthmatic crisis	1/1032 (0.1%)
Bronchospasm	1/1032 (0.1%)
Chronic obstructive pulmonary disease	3/1032 (0.3%)
Cough	47/1032 (4.6%)
Cyanosis central	1/1032 (0.1%)
Dry throat	1/1032 (0.1%)
Dysphonia	3/1032 (0.3%)
Dyspnoea	10/1032 (1%)
Dyspnoea exertional	3/1032 (0.3%)
Emphysema	1/1032 (0.1%)
Epistaxis	2/1032 (0.2%)
Haemoptysis	1/1032 (0.1%)
Hiccups	2/1032 (0.2%)
Interstitial lung disease	2/1032 (0.2%)
Lung disorder	2/1032 (0.2%)
Nasal congestion	6/1032 (0.6%)
Oropharyngeal pain	7/1032 (0.7%)
Orthopnoea	1/1032 (0.1%)
Pharyngeal disorder	6/1032 (0.6%)
Pharyngeal ulceration	2/1032 (0.2%)
Pleurisy	1/1032 (0.1%)
Pneumonitis	1/1032 (0.1%)
Productive cough	7/1032 (0.7%)
Rales	1/1032 (0.1%)
Respiratory disorder	3/1032 (0.3%)
Respiratory failure	1/1032 (0.1%)
Respiratory tract congestion	1/1032 (0.1%)
Rhinitis allergic	6/1032 (0.6%)
Rhinitis seasonal	1/1032 (0.1%)
Rhinorrhoea	10/1032 (1%)
Sinus congestion	2/1032 (0.2%)
Sleep apnoea syndrome	1/1032 (0.1%)
Tonsillar disorder	2/1032 (0.2%)
Tonsillar hypertrophy	1/1032 (0.1%)
Tonsillar ulcer	1/1032 (0.1%)
Skin and subcutaneous tissue disorders
Acne	4/1032 (0.4%)
Actinic keratosis	1/1032 (0.1%)
Alopecia	6/1032 (0.6%)
Dandruff	3/1032 (0.3%)
Dermal cyst	1/1032 (0.1%)
Dermatitis	9/1032 (0.9%)
Dermatitis acneiform	1/1032 (0.1%)
Dermatitis contact	2/1032 (0.2%)
Dermatosis	2/1032 (0.2%)
Drug eruption	1/1032 (0.1%)
Dry skin	9/1032 (0.9%)
Eczema	4/1032 (0.4%)
Eosinophilic pustular folliculitis	1/1032 (0.1%)
Erythema	4/1032 (0.4%)
Erythema multiforme	1/1032 (0.1%)
Facial wasting	1/1032 (0.1%)
Hyperhidrosis	6/1032 (0.6%)
Ingrowing nail	1/1032 (0.1%)
Intertrigo	1/1032 (0.1%)
Lichen planus	1/1032 (0.1%)
Lipoatrophy	2/1032 (0.2%)
Lipodystrophy acquired	7/1032 (0.7%)
Lipohypertrophy	2/1032 (0.2%)
Night sweats	7/1032 (0.7%)
Onychoclasis	2/1032 (0.2%)
Penile ulceration	1/1032 (0.1%)
Polymorphic light eruption	1/1032 (0.1%)
Prurigo	8/1032 (0.8%)
Pruritus	22/1032 (2.1%)
Psoriasis	4/1032 (0.4%)
Purpura	1/1032 (0.1%)
Rash	44/1032 (4.3%)
Rash erythematous	1/1032 (0.1%)
Rash macular	2/1032 (0.2%)
Rash maculo-papular	3/1032 (0.3%)
Rash papular	6/1032 (0.6%)
Rash pruritic	2/1032 (0.2%)
Rash vesicular	1/1032 (0.1%)
Seborrhoeic dermatitis	6/1032 (0.6%)
Skin exfoliation	2/1032 (0.2%)
Skin fibrosis	1/1032 (0.1%)
Skin fragility	1/1032 (0.1%)
Skin haemorrhage	1/1032 (0.1%)
Skin induration	1/1032 (0.1%)
Skin irritation	1/1032 (0.1%)
Skin lesion	6/1032 (0.6%)
Skin nodule	6/1032 (0.6%)
Skin reaction	1/1032 (0.1%)
Skin ulcer	3/1032 (0.3%)
Subcutaneous nodule	4/1032 (0.4%)
Swelling face	1/1032 (0.1%)
Urticaria	3/1032 (0.3%)
Social circumstances
Alcohol use	1/1032 (0.1%)
Surgical and medical procedures
Circumcision	1/1032 (0.1%)
Dental implantation	1/1032 (0.1%)
Prophylaxis	1/1032 (0.1%)
Tooth extraction	1/1032 (0.1%)
Wart excision	1/1032 (0.1%)
Vascular disorders
Aortic stenosis	1/1032 (0.1%)
Flushing	1/1032 (0.1%)
Haematoma	1/1032 (0.1%)
Haemorrhage	1/1032 (0.1%)
Hot flush	2/1032 (0.2%)
Hypertension	22/1032 (2.1%)
Hypertensive crisis	1/1032 (0.1%)
Hypotension	1/1032 (0.1%)
Orthostatic hypotension	5/1032 (0.5%)
Pallor	1/1032 (0.1%)
Phlebitis	1/1032 (0.1%)
Thrombophlebitis	1/1032 (0.1%)
Venoocclusive disease	1/1032 (0.1%)
Venous insufficiency	3/1032 (0.3%)
Venous thrombosis	1/1032 (0.1%)

Limitations/Caveats

Viral loads were not available for subjects uniformly as this expanded access study followed local country guidelines and practices that could vary significantly between countries, and testing frequency may have been affected by insurance status.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Results Point of Contact

Name/Title	Pfizer ClinicalTrials.gov Call Center
Organization	Pfizer, Inc.
Phone	1-800-718-1021
Email	ClinicalTrials.gov_Inquiries@pfizer.com

Responsible Party:

ViiV Healthcare

ClinicalTrials.gov Identifier:

NCT00426660

Other Study ID Numbers:

A4001050
2006-004306-50
EAP
NCT02783001

First Posted:

Jan 25, 2007

Last Update Posted:

Jun 29, 2016

Last Verified:

May 1, 2016

Expanded Access Program for Maraviroc At Multiple Centers

Study Details

Study Description

Brief Summary

Study Design

Arms and Interventions

Outcome Measures

Primary Outcome Measures

Secondary Outcome Measures

Eligibility Criteria

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Locations

Sponsors and Collaborators

Investigators

Study Documents (Full-Text)

More Information

Additional Information:

Publications

Study Results

Participant Flow

Baseline Characteristics

Outcome Measures

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Statistical Analysis 1

Statistical Analysis 2

Statistical Analysis 3

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Adverse Events

All Cause Mortality

Serious Adverse Events

Other (Not Including Serious) Adverse Events

Limitations/Caveats

More Information

Certain Agreements

Results Point of Contact