Adding Maraviroc to Antiretroviral Therapy for Suboptimal CD4 T-Cell Recovery Despite Sustained Virologic Suppression

• Sponsor: AIDS Clinical Trials Group (Other)
• Overall Status: Completed
• CT.gov ID: NCT00709111
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
• Enrollment: 34
• Locations: 29
• Arm: 1
• Duration (Months): 14.9
• Patients Per Site: 1.2
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

Despite viral suppression, antiretroviral therapy (ART) does not restore CD4+ T-cell counts in some subjects. The purpose of this study is to assess whether adding maraviroc (MVC) to a suppressive ART will result in a significant CD4+ T-cell count increase over 24 weeks in subjects with suboptimal CD4+ T-cell recovery despite sustained virologic suppression.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Maraviroc	N/A

Detailed Description

The majority of HIV-infected subjects with virologic suppression on antiretroviral therapy (ART) have a marked increase in CD4+ T-cell counts over the first year on treatment. However, a portion of these individuals show a suboptimal immune response and remain at an elevated risk for disease progression. The use of the CCR5 inhibitor maraviroc (MVC) is associated with enhanced CD4+ T-cell recovery in subjects who initiate ART. AIDS Clinical Trials Group (ACTG) A5256 studied the effect of ART intensification with MVC on CD4+ T-cell counts in subjects with suboptimal CD4 recovery despite sustained virologic suppression. Eligible subjects added MVC to their ART regimen, and continued MVC for 24 weeks. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC.

Subjects were seen through week 48 for clinical and laboratory evaluations, including plasma HIV-1 RNA, CD4+ T-cell count, and safety laboratories. Subjects had 2 baseline visits prior to starting MVC. Study visits were scheduled at weeks 4, 8, 12, 16, 22, 24, 36, 46, and 48. CD4+ T-cell counts were measured at every study visit and HIV-1 RNA at weeks 12, 24, 36, and 48, regardless of treatment status. Measures of activation, T-cell maturation, and apoptosis were performed at all weeks except 4, 8, and 16. At the end of the study, the pre-entry, entry, week 12, 22, 24, and 36 samples for the HIV-1 RNA by single-copy assay (SCA) were run. The week 46 and 48 samples were not run.

Study Design

• Study Type: Interventional
• Actual Enrollment: 34 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Pilot Trial of Maraviroc for Treatment of Subjects on Antiretroviral Therapy With Suboptimal CD4 T-cell Count Recovery Despite Sustained Virologic Suppression
• Study Start Date: Jan 1, 2009
• Actual Primary Completion Date: Oct 1, 2009
• Actual Study Completion Date: Apr 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Maraviroc Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.	Drug: Maraviroc; The maraviroc doses were 150 mg orally twice daily, 300 mg orally twice daily, or 600 mg orally twice daily, depending on the pharmacokinetic interaction with a subject's pre-study ART and non-ART drug regimen according to the package insert.; Other Names: MVC Selzentry

Outcome Measures

Primary Outcome Measures

1. Change in CD4+ T-cell Count [From baseline to week 24]

   Change was calculated as the week 24 CD4+ T-cell count (average of the week 22 and week 24 values) minus the baseline CD4+ T-cell count (average of pre-entry and entry values).

Secondary Outcome Measures

1. Proportion of Participants Achieving a 50-cell Increase in CD4+ T-cell Count [From baseline to week 24]

   Baseline was defined as the average of pre-entry and entry values. Week 24 was defined as the average of the week 22 and week 24 values.

2. Within-subject CD4+ T-cell Count Slopes [From baseline through week 24]

   The estimated mean slope was summarized across the population by using generalized estimating equations. Baseline was defined as the average of pre-entry and entry values. Week 24 was defined as the average of the week 22 and week 24 values.

3. Change From Within-subject Pre-treatment CD4+ T-cell Count Slopes to Corresponding Within-subject CD4+ T-cell Count Slopes From Baseline Through Week 24 [From pre-treatment through week 24]

   The estimated mean change in slopes was summarized across the population by using generalized estimating equations. Pre-treatment CD4+ T-cell counts (from at least 48 weeks prior to study entry) were recorded at screening from patient source documentation. Baseline was defined as the average of pre-entry and entry values. Week 24 was defined as the average of the week 22 and week 24 values.

4. Change in CD4+ T-cell Count [From week 24 to week 36]

   Change was calculated as week 36 CD4+ T-cell count minus the week 24 CD4+ T-cell count (average of the week 22 and week 24 values).

5. Change in CD4+ T-cell Count [From week 24 to week 48]

   Change was calculated as week 48 CD4+ T-cell count (average of week 46 and week 48) minus the week 24 CD4+ T-cell count (average of the week 22 and week 24 values).

6. Change in CD4 Percentage [From baseline to week 24]

   Change was calculated as the week 24 CD4 percentage (average of the week 22 and week 24 values) minus the baseline CD4 percentage (average of pre-entry and entry values).

7. Within-subject CD4 Percentage Slopes [From baseline through week 24]

   The estimated mean slope was summarized across the population by using generalized estimating equations. Baseline was defined as the average of pre-entry and entry values. Week 24 was defined as the average of the week 22 and week 24 values.

8. Change From Within-subject Pre-treatment CD4 Percentage Slopes to Corresponding Within-subject CD4 Percentage Slopes From Baseline Through Week 24 [From pre-treatment through week 24]

   The estimated mean change in slopes was summarized across the population by using generalized estimating equations. Pre-treatment CD4 percentage (from at least 48 weeks prior to study entry) were recorded at screening from patient source documentation. Baseline was defined as the average of pre-entry and entry values. Week 24 was defined as the average of the week 22 and week 24 values.

9. Change in CD4 Percentage [From week 24 to week 36]

   Change was calculated as week 36 CD4 percentage minus the week 24 CD4 percentage (average of the week 22 and week 24 values).

10. Change in CD4 Percentage [From week 24 to week 48]

    Change was calculated as week 48 CD4 percentage (average of week 46 and week 48) minus the week 24 CD4 percentage (average of the week 22 and week 24 values).

11. Number of Subjects Who Experience a Grade 2, 3 or 4 Signs and Symptoms, Grade 3 or 4 Laboratory Abnormalities, or Death. [From baseline through week 24]

    Events with date of onset or specimen date prior to first dose of MVC or after the last dose of MVC were excluded. Signs and symptoms with a date of onset the same as the first dose of MVC were excluded if confirmed by the site to be before the first dose. Lab abnormalities with the date of specimen the same as the date of the first dose of MVC were excluded on the assumption that the specimen was drawn before the first dose. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables, where Grade 1=Mild, 2=Moderate, 3=Severe, 4=Potentially life-threatening.

12. Change in Percentage of CD4+ T-cells That Are: naïve (%CD45RA+CCR7+), Central Memory (%CD45RA-CCR7+), Effector Memory (%CD45RA-CCR7-), Effector (%CD45RA+CCR7-), %HLA-DR+CD38+, %CD38+, %Ki67+, %caspase3+, %Bcl-2-, and %CD57+ [From baseline to week 24]

    Change was calculated as the week 24 result (average of the week 22 and week 24 values) minus the baseline result (average of pre-entry and entry values).

13. Change in Percentage of CD8+ T-cells That Are: naïve (%CD45RA+CCR7+), Central Memory (%CD45RA-CCR7+), Effector Memory (%CD45RA-CCR7-), Effector (%CD45RA+CCR7-), %HLA-DR+CD38+, %CD38+, %Ki67+, %caspase3+, %Bcl-2-, and %CD57+ [From baseline to week 24]

    Change was calculated as the week 24 result (average of the week 22 and week 24 values) minus the baseline result (average of pre-entry and entry values).

14. Change in Percentage of CD4+ T-cells That Are: naïve (%CD45RA+CCR7+), Central Memory (%CD45RA-CCR7+), Effector Memory (%CD45RA-CCR7-), Effector (%CD45RA+CCR7-), %HLA-DR+CD38+, %CD38+, %Ki67+, %caspase3+, %Bcl-2-, and %CD57+ [From week 24 to week 36]

    Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values).

15. Change in Percentage of CD8+ T-cells That Are: naïve (%CD45RA+CCR7+), Central Memory (%CD45RA-CCR7+), Effector Memory (%CD45RA-CCR7-), Effector (%CD45RA+CCR7-), %HLA-DR+CD38+, %CD38+, %Ki67+, %caspase3+, %Bcl-2-, and %CD57+ [From week 24 to week 36]

    Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values).

16. Change in Percentage of CD4+ T-cells That Are: naïve (%CD45RA+CCR7+), Central Memory (%CD45RA-CCR7+), Effector Memory (%CD45RA-CCR7-), Effector (%CD45RA+CCR7-), %HLA-DR+CD38+, %CD38+, %Ki67+, %caspase3+, %Bcl-2-, and %CD57+ [From week 24 to week 48]

    Change was calculated as week 48 result (average of week 46 and week 48) minus the week 24 result (average of the week 22 and week 24 values).

17. Change in Percentage of CD8+ T-cells That Are: naïve (%CD45RA+CCR7+), Central Memory (%CD45RA-CCR7+), Effector Memory (%CD45RA-CCR7-), Effector (%CD45RA+CCR7-), %HLA-DR+CD38+, %CD38+, %Ki67+, %caspase3+, %Bcl-2-, and %CD57+ [From week 24 to week 48]

    Change was calculated as week 48 result (average of week 46 and week 48) minus the week 24 result (average of the week 22 and week 24 values).

18. Change in Soluble CD14 [From baseline to week 24]

    Change was calculated as the week 24 result (average of the week 22 and week 24 values) minus the baseline result (average of pre-entry and entry values). Soluble CD14 is a marker of gut microbial translocation.

19. Change in Soluble CD14 [From week 24 to week 36]

    Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values). Soluble CD14 is a marker of gut microbial translocation.

20. Change in Soluble CD14 [From week 24 to week 48]

    Change was calculated as week 48 result (average of week 46 and week 48) minus the week 24 result (average of the week 22 and week 24 values). Soluble CD14 is a marker of gut microbial translocation.

21. Change in High Sensitivity C-reactive Protein (Hs-CRP) [From baseline to week 24]

    Change was calculated as the week 24 result (average of the week 22 and week 24 values) minus the baseline result (average of pre-entry and entry values).

22. Change in Interleukin (IL)-6, Monocyte Chemoattractant Protein (MCP)-1, MCP-2, and Plasma CD40 Ligand (CD40L) [From baseline to week 24]

    Change was calculated as the week 24 result (average of the week 22 and week 24 values) minus the baseline result (average of pre-entry and entry values).

23. Change in Intercellular Cell Adhesion Molecule (ICAM)-1, Plasma P-selectin, Soluble TNFRII (sTNFRII), and Matrix Metalloproteinase (MMP)-9 [From baseline to week 24]

    Change was calculated as the week 24 result (average of the week 22 and week 24 values) minus the baseline result (average of pre-entry and entry values).

24. Change in D-dimer [From baseline to week 24]

    Change was calculated as the week 24 result (average of the week 22 and week 24 values) minus the baseline result (average of pre-entry and entry values).

25. Change in Hs-CRP [From week 24 to week 36]

    Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values).

26. Change in IL-6, MCP-1, MCP-2, and Plasma CD40L [From week 24 to week 36]

    Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values).

27. Change in ICAM-1, Plasma P-selectin, sTNFRII, and MMP-9 [From week 24 to week 36]

    Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values).

28. Change in D-dimer [From week 24 to week 36]

    Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values).

29. Change in Hs-CRP [From week 24 to week 48]

    Change was calculated as week 48 result (average of week 46 and week 48) minus the week 24 result (average of the week 22 and week 24 values).

30. Change in IL-6, MCP-1, MCP-2, and Plasma CD40L [From week 24 to week 48]

    Change was calculated as week 48 result (average of week 46 and week 48) minus the week 24 result (average of the week 22 and week 24 values).

31. Change in ICAM-1, Plasma P-selectin, sTNFRII, and MMP-9 [From week 24 to week 48]

    Change was calculated as week 48 result (average of week 46 and week 48) minus the week 24 result (average of the week 22 and week 24 values).

32. Change in D-dimer [From week 24 to week 48]

    Change was calculated as week 48 result (average of week 46 and week 48) minus the week 24 result (average of the week 22 and week 24 values).

33. Proportion of Participants With Detectable HIV-1 Viremia as Measured by Single Copy Assay (SCA) [At weeks -1 (pre-entry), 0 (entry), 12, 22, 24, and 36]

    A subject was considered detectable at a specific week if HIV-1 RNA by SCA >=1 copy/ml.

34. Drug Adherence Assessed as Number of Missed Doses Over a 4-day Recall [At weeks 4, 12, and 24]

    Self-reported MVC adherence data were based on a four-day (8 expected doses) recall. Based on the wording of the Self Report case report form (CRF), participants reporting that they were currently taking MVC that then failed to complete the record of the number of missed doses were assumed to have no missed doses to report. Missing adherence assessments at a time point of interest were ignored and only those participants completing an adherence assessment at least one time point of interest were included.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• HIV-1 infection

• On ART for at least 48 weeks prior to study entry with a regimen that includes three or more antiretroviral medications

• No change in ART regimen for at least 24 weeks prior to study entry

• Screening CD4+ T-cell count less than 250 obtained within 60 days prior to study entry

• Stable CD4+ T-cell count for at least 48 weeks prior to study entry (as assessed by an estimated CD4+ T-cell count slope between -20 and +20 cells/year)

• Screening HIV-1 RNA below the limit of detection using an FDA-approved assay obtained within 60 days prior to study entry

• All other plasma HIV-1 RNA measurements in the 48 weeks prior to study entry must be below the limit of detection

• Laboratory values obtained within 60 days prior to study entry:

• Absolute neutrophil count (ANC) >=750/µL

• Hemoglobin >=9.0 g/dL for female subjects and >=10.0 g/dL for male subjects

• Platelet count >=50,000/ µL

• Calculated creatinine clearance (CrCl) >=30 mL/min

• Aspartate aminotransferase (serum glutamic oxaloacetic transaminase), alanine aminotransferase (serum glutamic pyruvic transaminase), and alkaline phosphatase <=5 X Upper Limit of Normal (ULN)

• Direct bilirubin <=2.5 X ULN

• Females of reproductive potential will need a negative serum or urine pregnancy test within 48 hours prior to study entry

• Agree not to participate in the conception process, and if participating in sexual activity that could lead to pregnancy, the subject/partner must use at least two reliable forms of contraceptives while receiving study treatment and for 6 weeks after stopping study treatment.

Exclusion Criteria:

• Unstable clinical condition

• Currently breast-feeding or pregnant

• Use of immunomodulators or cancer chemotherapy or radiation treatment within 12 months prior to study entry

• An acute AIDS-defining illness within 60 days prior to study entry

• Known allergy/sensitivity or hypersensitivity to components of MVC, including allergy or hypersensitivity to soya lecithin, soya or peanuts

• Active drug or alcohol abuse that, in the opinion of the investigator, would interfere with adherence to study regimens

• Serious illness requiring systemic treatment and/or hospitalization within 60 days prior to study entry

• Receipt of a vaccine within 30 days prior to study entry

• Current or previous use of a CCR5 inhibitor

• Plan to change background ART regimen within 24 weeks after study entry

• Receipt of experimental or non-experimental medications for the purpose of raising CD4+ T-cell counts within 6 months prior to study entry

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alabama Therapeutics CRS (5801)	Birmingham	Alabama	United States	35294
2	UCLA CARE Center CRS (601)	Los Angeles	California	United States	90035
3	Stanford CRS (501)	Palo Alto	California	United States	94304
4	Ucsd, Avrc Crs (701)	San Diego	California	United States	92103
5	Ucsf Aids Crs (801)	San Francisco	California	United States	94110
6	Georgetown University CRS (GU CRS) (1008)	Washington	District of Columbia	United States	20007
7	Univ. of Miami AIDS CRS (901)	Miami	Florida	United States	33136
8	The Ponce de Leon Ctr. CRS (5802)	Atlanta	Georgia	United States	30308
9	Northwestern University CRS (2701)	Chicago	Illinois	United States	60611
10	IHV Baltimore Treatment CRS (4651)	Baltimore	Maryland	United States	21201
11	Johns Hopkins Adult AIDS CRS (201)	Baltimore	Maryland	United States	21205
12	Massachusetts General Hospital ACTG CRS (101)	Boston	Massachusetts	United States	02114
13	Brigham and Women's Hosp. ACTG CRS (107)	Boston	Massachusetts	United States	02115
14	Boston Medical Center ACTG CRS (104)	Boston	Massachusetts	United States	02118
15	Washington University CRS (2101)	Saint Louis	Missouri	United States	63110
16	Cornell CRS (7804)	New York	New York	United States	10011
17	NY Univ. HIV/AIDS CRS (401)	New York	New York	United States	10016
18	AIDS Care CRS (1108)	Rochester	New York	United States	14642
19	Univ. of Rochester ACTG CRS (1101)	Rochester	New York	United States	14642
20	Unc Aids Crs (3201)	Chapel Hill	North Carolina	United States	27516
21	Duke Univ. Med. Ctr. Adult CRS (1601)	Durham	North Carolina	United States	27710
22	Univ. of Cincinnati CRS (2401)	Cincinnati	Ohio	United States	45267
23	MetroHealth CRS (2503)	Cleveland	Ohio	United States	44109
24	The Ohio State Univ. AIDS CRS (2301)	Columbus	Ohio	United States	43210
25	Hosp. of the Univ. of Pennsylvania CRS (6201)	Philadelphia	Pennsylvania	United States	19104
26	Pittsburgh CRS (1001)	Pittsburgh	Pennsylvania	United States	15213
27	Vanderbilt Therapeutics CRS (3652)	Nashville	Tennessee	United States	37204
28	Peabody Health Ctr. CRS (31443)	Dallas	Texas	United States	75215
29	Houston AIDS Research Team CRS (31473)	Houston	Texas	United States	77030

Sponsors and Collaborators

• AIDS Clinical Trials Group
• National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

• Study Chair: Timothy J. Wilkin, MD, MPH, Cornell Clinical Research Site
• Study Chair: Roy Gulick, MD, MPH, Cornell HIV Clinical Trials Unit

Study Documents (Full-Text)

None provided.

More Information

Publications

• Fadel H, Temesgen Z. Maraviroc. Drugs Today (Barc). 2007 Nov;43(11):749-58. doi: 10.1358/dot.2007.43.11.1131763. Review.
• MacArthur RD, Novak RM. Reviews of anti-infective agents: maraviroc: the first of a new class of antiretroviral agents. Clin Infect Dis. 2008 Jul 15;47(2):236-41. doi: 10.1086/589289. Review.

• Responsible Party: AIDS Clinical Trials Group
• ClinicalTrials.gov Identifier: NCT00709111
• Other Study ID Numbers: ACTG A5256; 1U01AI068636
• First Posted: Jul 3, 2008
• Last Update Posted: Oct 12, 2018
• Last Verified: Sep 1, 2018

• Keywords provided by AIDS Clinical Trials Group: CCR5 antagonist; CD4 T-cell count; immune activation; treatment experienced
• Additional relevant MeSH terms: HIV Infections; Maraviroc

Study Results

Participant Flow

Recruitment Details	Recruited at 29 AIDS Clinical Trials Units in the United States between January 14, 2009 and May 4, 2009
Pre-assignment Detail	34 enrolled

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Period Title: Overall Study
STARTED	34
Week 22/24	33
COMPLETED	32
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Overall Participants	34
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	50
Sex: Female, Male (Count of Participants)
Female	2 5.9%
Male	32 94.1%
Race/Ethnicity, Customized (participants) [Number]
White Non-Hispanic	24 70.6%
Black Non-Hispanic	6 17.6%
Hispanic (Regardless of Race)	4 11.8%
Baseline CD4+ T-cell count (cells/mm^3) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [cells/mm^3]	153
Baseline CD4 percentage (% of total lymphocytes) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [% of total lymphocytes]	13
Baseline CD8+ T-cell count (cells/mm^3) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [cells/mm^3]	559
Time with suppressed HIV-1 RNA prior to study entry (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	3.0

Outcome Measures

1. Primary Outcome

Title	Change in CD4+ T-cell Count
Description	Change was calculated as the week 24 CD4+ T-cell count (average of the week 22 and week 24 values) minus the baseline CD4+ T-cell count (average of pre-entry and entry values).
Time Frame	From baseline to week 24

Outcome Measure Data

Analysis Population Description

As-treated: Only participants with either a week 22 CD4+ T-cell count or a week 24 CD4+ T-cell count obtained while receiving MVC without change in background regimen were included.

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Measure Participants	32
Median (90% Confidence Interval) [cells/mm^3]	12

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Maraviroc
	Comments	The change in CD4+ T-cell count from baseline to week 24 was compared against the null hypothesis of change <20 cells/mm^3. The study was powered to yield 80% power to show that there was >=20 cells/mm^3 increase in CD4+ T-cell count assuming an underlying change in CD4+ T-cell counts induced by MVC of 50 cells/mm^3, a standard deviation of 60 cells/mm^3 around the mean CD4+ T-cell count change, 10% lost-to-follow-up or premature MVC discontinuation rate, and one-sided type 1 error of 0.05.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.97
	Comments	The p-value is one-sided with a nominal level of 0.05.
	Method	Wilcoxon signed-rank, 1-sided
	Comments

2. Secondary Outcome

Title	Proportion of Participants Achieving a 50-cell Increase in CD4+ T-cell Count
Description	Baseline was defined as the average of pre-entry and entry values. Week 24 was defined as the average of the week 22 and week 24 values.
Time Frame	From baseline to week 24

Outcome Measure Data

Analysis Population Description

As-treated: Only participants with either a week 22 CD4+ T-cell count or a week 24 CD4+ T-cell count obtained while receiving MVC without change in background regimen were included.

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Measure Participants	32
Number (90% Confidence Interval) [proportion of participants]	0.06 0.2%

3. Secondary Outcome

Title	Within-subject CD4+ T-cell Count Slopes
Description	The estimated mean slope was summarized across the population by using generalized estimating equations. Baseline was defined as the average of pre-entry and entry values. Week 24 was defined as the average of the week 22 and week 24 values.
Time Frame	From baseline through week 24

Outcome Measure Data

Analysis Population Description

As-treated: Participants with CD4+ T-cell counts available at least through visit week 22 while receiving MVC without change in background regimen were included.

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Measure Participants	32
Mean (90% Confidence Interval) [cells/mm^3/year]	24.7

4. Secondary Outcome

Title	Change From Within-subject Pre-treatment CD4+ T-cell Count Slopes to Corresponding Within-subject CD4+ T-cell Count Slopes From Baseline Through Week 24
Description	The estimated mean change in slopes was summarized across the population by using generalized estimating equations. Pre-treatment CD4+ T-cell counts (from at least 48 weeks prior to study entry) were recorded at screening from patient source documentation. Baseline was defined as the average of pre-entry and entry values. Week 24 was defined as the average of the week 22 and week 24 values.
Time Frame	From pre-treatment through week 24

Outcome Measure Data

Analysis Population Description

As-treated: Participants with CD4+ T-cell counts available at least through visit week 22 while receiving MVC without change in background regimen were included.

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Measure Participants	32
Mean (90% Confidence Interval) [cells/mm^3/year]	25.2

5. Secondary Outcome

Title	Change in CD4+ T-cell Count
Description	Change was calculated as week 36 CD4+ T-cell count minus the week 24 CD4+ T-cell count (average of the week 22 and week 24 values).
Time Frame	From week 24 to week 36

Outcome Measure Data

Analysis Population Description

As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 CD4+ T-cell count obtained while receiving background regimen were included.

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Measure Participants	31
Median (90% Confidence Interval) [cells/mm^3]	-3

6. Secondary Outcome

Title	Change in CD4+ T-cell Count
Description	Change was calculated as week 48 CD4+ T-cell count (average of week 46 and week 48) minus the week 24 CD4+ T-cell count (average of the week 22 and week 24 values).
Time Frame	From week 24 to week 48

Outcome Measure Data

Analysis Population Description

As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 CD4+ T-cell count or a week 48 CD4+ T-cell count obtained while receiving background regimen were included.

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Measure Participants	31
Median (90% Confidence Interval) [cells/mm^3]	7

7. Secondary Outcome

Title	Change in CD4 Percentage
Description	Change was calculated as the week 24 CD4 percentage (average of the week 22 and week 24 values) minus the baseline CD4 percentage (average of pre-entry and entry values).
Time Frame	From baseline to week 24

Outcome Measure Data

Analysis Population Description

As-treated: Only participants with either a week 22 CD4 percentage or a week 24 CD4 percentage obtained while receiving MVC without change in background regimen were included.

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Measure Participants	32
Median (90% Confidence Interval) [% of total lymphocytes]	0.5

8. Secondary Outcome

Title	Within-subject CD4 Percentage Slopes
Description	The estimated mean slope was summarized across the population by using generalized estimating equations. Baseline was defined as the average of pre-entry and entry values. Week 24 was defined as the average of the week 22 and week 24 values.
Time Frame	From baseline through week 24

Outcome Measure Data

Analysis Population Description

As-treated: Participants with CD4 percentage available at least through visit week 22 while receiving MVC without change in background regimen were included. Four of these subjects did not have pre-treatment (from at least 48 weeks prior to study entry) CD4 percentage results available.

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Measure Participants	28
Mean (90% Confidence Interval) [% of total lymphocytes/year]	-0.3

9. Secondary Outcome

Title	Change From Within-subject Pre-treatment CD4 Percentage Slopes to Corresponding Within-subject CD4 Percentage Slopes From Baseline Through Week 24
Description	The estimated mean change in slopes was summarized across the population by using generalized estimating equations. Pre-treatment CD4 percentage (from at least 48 weeks prior to study entry) were recorded at screening from patient source documentation. Baseline was defined as the average of pre-entry and entry values. Week 24 was defined as the average of the week 22 and week 24 values.
Time Frame	From pre-treatment through week 24

Outcome Measure Data

Analysis Population Description

As-treated: Participants with CD4 percentage available at least through visit week 22 while receiving MVC without change in background regimen were included. Four of these subjects did not have pre-treatment (from at least 48 weeks prior to study entry) CD4 percentage results available.

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Measure Participants	28
Mean (90% Confidence Interval) [% of total lymphocytes/year]	-1.0

10. Secondary Outcome

Title	Change in CD4 Percentage
Description	Change was calculated as week 36 CD4 percentage minus the week 24 CD4 percentage (average of the week 22 and week 24 values).
Time Frame	From week 24 to week 36

Outcome Measure Data

Analysis Population Description

As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 CD4 percentage obtained while receiving background regimen were included.

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Measure Participants	31
Median (90% Confidence Interval) [% of total lymphocytes]	0.2

11. Secondary Outcome

Title	Change in CD4 Percentage
Description	Change was calculated as week 48 CD4 percentage (average of week 46 and week 48) minus the week 24 CD4 percentage (average of the week 22 and week 24 values).
Time Frame	From week 24 to week 48

Outcome Measure Data

Analysis Population Description

As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 CD4 percentage or a week 48 CD4 percentage obtained while receiving background regimen were included.

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Measure Participants	31
Median (90% Confidence Interval) [% of total lymphocytes]	0.5

12. Secondary Outcome

Title	Number of Subjects Who Experience a Grade 2, 3 or 4 Signs and Symptoms, Grade 3 or 4 Laboratory Abnormalities, or Death.
Description	Events with date of onset or specimen date prior to first dose of MVC or after the last dose of MVC were excluded. Signs and symptoms with a date of onset the same as the first dose of MVC were excluded if confirmed by the site to be before the first dose. Lab abnormalities with the date of specimen the same as the date of the first dose of MVC were excluded on the assumption that the specimen was drawn before the first dose. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables, where Grade 1=Mild, 2=Moderate, 3=Severe, 4=Potentially life-threatening.
Time Frame	From baseline through week 24

Outcome Measure Data

Analysis Population Description

As-treated: Participants who initiated treatment were included. Follow-up while receiving MVC without change in background regimen were included.

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Measure Participants	34
grade>=2 signs/symptoms or grade>=3 lab abnorm.	15 44.1%
deaths	0 0%

13. Secondary Outcome

Title	Change in Percentage of CD4+ T-cells That Are: naïve (%CD45RA+CCR7+), Central Memory (%CD45RA-CCR7+), Effector Memory (%CD45RA-CCR7-), Effector (%CD45RA+CCR7-), %HLA-DR+CD38+, %CD38+, %Ki67+, %caspase3+, %Bcl-2-, and %CD57+
Description	Change was calculated as the week 24 result (average of the week 22 and week 24 values) minus the baseline result (average of pre-entry and entry values).
Time Frame	From baseline to week 24

Outcome Measure Data

Analysis Population Description

As-treated: Only participants with either a week 22 result or a week 24 result obtained while receiving MVC without change in background regimen were included.

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Measure Participants	32
naïve (%CD45RA+CCR7+)	-1.3
central memory (%CD45RA-CCR7+)	-4.8
effector memory (%CD45RA-CCR7-)	5.8
effector (%CD45RA+CCR7-)	0.7
%HLA-DR+CD38+	-1.3
%CD38+	-14.8
%Ki67+	-1.0
%caspase3+	-1.1
%Bcl-2-	0.7
%CD57+	1.8

14. Secondary Outcome

Title	Change in Percentage of CD8+ T-cells That Are: naïve (%CD45RA+CCR7+), Central Memory (%CD45RA-CCR7+), Effector Memory (%CD45RA-CCR7-), Effector (%CD45RA+CCR7-), %HLA-DR+CD38+, %CD38+, %Ki67+, %caspase3+, %Bcl-2-, and %CD57+
Description	Change was calculated as the week 24 result (average of the week 22 and week 24 values) minus the baseline result (average of pre-entry and entry values).
Time Frame	From baseline to week 24

Outcome Measure Data

Analysis Population Description

As-treated: Only participants with either a week 22 result or a week 24 result obtained while receiving MVC without change in background regimen were included.

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Measure Participants	32
naïve (%CD45RA+CCR7+)	-3.3
central memory (%CD45RA-CCR7+)	-1.0
effector memory (%CD45RA-CCR7-)	2.5
effector (%CD45RA+CCR7-)	2.0
%HLA-DR+CD38+	-1.4
%CD38+	-14.2
%Ki67+	-0.1
%caspase3+	-0.7
%Bcl-2-	0.5
%CD57+	3.6

15. Secondary Outcome

Title	Change in Percentage of CD4+ T-cells That Are: naïve (%CD45RA+CCR7+), Central Memory (%CD45RA-CCR7+), Effector Memory (%CD45RA-CCR7-), Effector (%CD45RA+CCR7-), %HLA-DR+CD38+, %CD38+, %Ki67+, %caspase3+, %Bcl-2-, and %CD57+
Description	Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values).
Time Frame	From week 24 to week 36

Outcome Measure Data

Analysis Population Description

As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 result obtained while receiving background regimen were included.

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Measure Participants	31
naïve (%CD45RA+CCR7+)	3.5
central memory (%CD45RA-CCR7+)	-1.4
effector memory (%CD45RA-CCR7-)	-3.7
effector (%CD45RA+CCR7-)	0.1
%HLA-DR+CD38+	-0.2
%CD38+	2.8
%Ki67+	0.1
%caspase3+	0.3
%Bcl-2-	-0.6
%CD57+	-0.9

16. Secondary Outcome

Title	Change in Percentage of CD8+ T-cells That Are: naïve (%CD45RA+CCR7+), Central Memory (%CD45RA-CCR7+), Effector Memory (%CD45RA-CCR7-), Effector (%CD45RA+CCR7-), %HLA-DR+CD38+, %CD38+, %Ki67+, %caspase3+, %Bcl-2-, and %CD57+
Description	Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values).
Time Frame	From week 24 to week 36

Outcome Measure Data

Analysis Population Description

As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 result obtained while receiving background regimen were included.

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Measure Participants	31
naïve (%CD45RA+CCR7+)	2.4
central memory (%CD45RA-CCR7+)	-0.3
effector memory (%CD45RA-CCR7-)	-5.1
effector (%CD45RA+CCR7-)	2.4
%HLA-DR+CD38+	-0.8
%CD38+	-1.6
%Ki67+	0.1
%caspase3+	0.2
%Bcl-2-	-0.3
%CD57+	-2.8

17. Secondary Outcome

Title	Change in Percentage of CD4+ T-cells That Are: naïve (%CD45RA+CCR7+), Central Memory (%CD45RA-CCR7+), Effector Memory (%CD45RA-CCR7-), Effector (%CD45RA+CCR7-), %HLA-DR+CD38+, %CD38+, %Ki67+, %caspase3+, %Bcl-2-, and %CD57+
Description	Change was calculated as week 48 result (average of week 46 and week 48) minus the week 24 result (average of the week 22 and week 24 values).
Time Frame	From week 24 to week 48

Outcome Measure Data

Analysis Population Description

As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 result or a week 48 result obtained while receiving background regimen were included.

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Measure Participants	31
naïve (%CD45RA+CCR7+)	2.1
central memory (%CD45RA-CCR7+)	-3.1
effector memory (%CD45RA-CCR7-)	0.4
effector (%CD45RA+CCR7-)	1.2
%HLA-DR+CD38+	0.4
%CD38+	7.1
%Ki67+	0.1
%caspase3+	0.7
%Bcl-2-	-0.5
%CD57+	-0.4

18. Secondary Outcome

Title	Change in Percentage of CD8+ T-cells That Are: naïve (%CD45RA+CCR7+), Central Memory (%CD45RA-CCR7+), Effector Memory (%CD45RA-CCR7-), Effector (%CD45RA+CCR7-), %HLA-DR+CD38+, %CD38+, %Ki67+, %caspase3+, %Bcl-2-, and %CD57+
Description	Change was calculated as week 48 result (average of week 46 and week 48) minus the week 24 result (average of the week 22 and week 24 values).
Time Frame	From week 24 to week 48

Outcome Measure Data

Analysis Population Description

As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 result or a week 48 result obtained while receiving background regimen were included.

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Measure Participants	31
naïve (%CD45RA+CCR7+)	1.1
central memory (%CD45RA-CCR7+)	-0.5
effector memory (%CD45RA-CCR7-)	-0.1
effector (%CD45RA+CCR7-)	0.4
%HLA-DR+CD38+	0.1
%CD38+	4.2
%Ki67+	0.2
%caspase3+	0.5
%Bcl-2-	0
%CD57+	-1.4

19. Secondary Outcome

Title	Change in Soluble CD14
Description	Change was calculated as the week 24 result (average of the week 22 and week 24 values) minus the baseline result (average of pre-entry and entry values). Soluble CD14 is a marker of gut microbial translocation.
Time Frame	From baseline to week 24

Outcome Measure Data

Analysis Population Description

As-treated: Only participants with either a week 22 result or a week 24 result obtained while receiving MVC without change in background regimen were included.

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Measure Participants	32
Median (90% Confidence Interval) [mcg/ml]	-0.03

20. Secondary Outcome

Title	Change in Soluble CD14
Description	Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values). Soluble CD14 is a marker of gut microbial translocation.
Time Frame	From week 24 to week 36

Outcome Measure Data

Analysis Population Description

As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 result obtained while receiving background regimen were included.

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Measure Participants	31
Median (90% Confidence Interval) [mcg/ml]	-0.17

21. Secondary Outcome

Title	Change in Soluble CD14
Description	Change was calculated as week 48 result (average of week 46 and week 48) minus the week 24 result (average of the week 22 and week 24 values). Soluble CD14 is a marker of gut microbial translocation.
Time Frame	From week 24 to week 48

Outcome Measure Data

Analysis Population Description

As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 result or a week 48 result obtained while receiving background regimen were included.

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Measure Participants	31
Median (90% Confidence Interval) [mcg/ml]	-0.16

22. Secondary Outcome

Title	Change in High Sensitivity C-reactive Protein (Hs-CRP)
Description	Change was calculated as the week 24 result (average of the week 22 and week 24 values) minus the baseline result (average of pre-entry and entry values).
Time Frame	From baseline to week 24

Outcome Measure Data

Analysis Population Description

As-treated: Only participants with either a week 22 result or a week 24 result obtained while receiving MVC without change in background regimen were included.

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Measure Participants	32
Median (90% Confidence Interval) [mg/dl]	0.01

23. Secondary Outcome

Title	Change in Interleukin (IL)-6, Monocyte Chemoattractant Protein (MCP)-1, MCP-2, and Plasma CD40 Ligand (CD40L)
Description	Change was calculated as the week 24 result (average of the week 22 and week 24 values) minus the baseline result (average of pre-entry and entry values).
Time Frame	From baseline to week 24

Outcome Measure Data

Analysis Population Description

As-treated: Only participants with either a week 22 result or a week 24 result obtained while receiving MVC without change in background regimen were included.

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Measure Participants	32
IL-6	0.7
MCP-1	44.6
MCP-2	-1.4
CD40L	-1.8

24. Secondary Outcome

Title	Change in Intercellular Cell Adhesion Molecule (ICAM)-1, Plasma P-selectin, Soluble TNFRII (sTNFRII), and Matrix Metalloproteinase (MMP)-9
Description	Change was calculated as the week 24 result (average of the week 22 and week 24 values) minus the baseline result (average of pre-entry and entry values).
Time Frame	From baseline to week 24

Outcome Measure Data

Analysis Population Description

As-treated: Only participants with either a week 22 result or a week 24 result obtained while receiving MVC without change in background regimen were included.

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Measure Participants	32
ICAM-1	-25.7
P-selectin	-11.7
sTNFRII	0.18
MMP-9	-12.5

25. Secondary Outcome

Title	Change in D-dimer
Description	Change was calculated as the week 24 result (average of the week 22 and week 24 values) minus the baseline result (average of pre-entry and entry values).
Time Frame	From baseline to week 24

Outcome Measure Data

Analysis Population Description

As-treated: Only participants with either a week 22 result or a week 24 result obtained while receiving MVC without change in background regimen were included.

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Measure Participants	32
Median (90% Confidence Interval) [mcg/ml]	0.09

26. Secondary Outcome

Title	Change in Hs-CRP
Description	Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values).
Time Frame	From week 24 to week 36

Outcome Measure Data

Analysis Population Description

As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 result obtained while receiving background regimen were included.

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Measure Participants	31
Median (90% Confidence Interval) [mg/dl]	-0.01

27. Secondary Outcome

Title	Change in IL-6, MCP-1, MCP-2, and Plasma CD40L
Description	Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values).
Time Frame	From week 24 to week 36

Outcome Measure Data

Analysis Population Description

As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 result obtained while receiving background regimen were included.

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Measure Participants	31
IL-6	-0.9
MCP-1	-6.9
MCP-2	0.1
CD40L	0

28. Secondary Outcome

Title	Change in ICAM-1, Plasma P-selectin, sTNFRII, and MMP-9
Description	Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values).
Time Frame	From week 24 to week 36

Outcome Measure Data

Analysis Population Description

As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 result obtained while receiving background regimen were included.

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Measure Participants	31
ICAM-1	-20.9
P-selectin	-13.7
sTNFRII	-0.05
MMP-9	11.3

29. Secondary Outcome

Title	Change in D-dimer
Description	Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values).
Time Frame	From week 24 to week 36

Outcome Measure Data

Analysis Population Description

As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 result obtained while receiving background regimen were included.

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Measure Participants	31
Median (90% Confidence Interval) [mcg/ml]	0.01

30. Secondary Outcome

Title	Change in Hs-CRP
Description	Change was calculated as week 48 result (average of week 46 and week 48) minus the week 24 result (average of the week 22 and week 24 values).
Time Frame	From week 24 to week 48

Outcome Measure Data

Analysis Population Description

As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 result or a week 48 result obtained while receiving background regimen were included.

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Measure Participants	31
Median (90% Confidence Interval) [mg/dl]	0.01

31. Secondary Outcome

Title	Change in IL-6, MCP-1, MCP-2, and Plasma CD40L
Description	Change was calculated as week 48 result (average of week 46 and week 48) minus the week 24 result (average of the week 22 and week 24 values).
Time Frame	From week 24 to week 48

Outcome Measure Data

Analysis Population Description

As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 result or a week 48 result obtained while receiving background regimen were included.

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Measure Participants	31
IL-6	-0.5
MCP-1	7.7
MCP-2	0.2
CD40L	32.3

32. Secondary Outcome

Title	Change in ICAM-1, Plasma P-selectin, sTNFRII, and MMP-9
Description	Change was calculated as week 48 result (average of week 46 and week 48) minus the week 24 result (average of the week 22 and week 24 values).
Time Frame	From week 24 to week 48

Outcome Measure Data

Analysis Population Description

As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 result or a week 48 result obtained while receiving background regimen were included.

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Measure Participants	31
ICAM-1	-32.4
P-selectin	-17.3
sTNFRII	0.03
MMP-9	12.8

33. Secondary Outcome

Title	Change in D-dimer
Description	Change was calculated as week 48 result (average of week 46 and week 48) minus the week 24 result (average of the week 22 and week 24 values).
Time Frame	From week 24 to week 48

Outcome Measure Data

Analysis Population Description

As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 result or a week 48 result obtained while receiving background regimen were included.

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Measure Participants	31
Median (90% Confidence Interval) [mcg/ml]	-0.02

34. Secondary Outcome

Title	Proportion of Participants With Detectable HIV-1 Viremia as Measured by Single Copy Assay (SCA)
Description	A subject was considered detectable at a specific week if HIV-1 RNA by SCA >=1 copy/ml.
Time Frame	At weeks -1 (pre-entry), 0 (entry), 12, 22, 24, and 36

Outcome Measure Data

Analysis Population Description

As-treated: Participants who initiated treatment were included. Through week 24, follow-up while receiving MVC without change in background regimen were included. For week 36, only results obtained while receiving background regimen were included. One subject who had a large rise (blip) in viral load at week 24 was excluded.

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Measure Participants	31
Week -1 (N=31)	0.35 1%
Week 0 (N=31)	0.32 0.9%
Week 12 (N=30)	0.43 1.3%
Week 22 (N=31)	0.29 0.9%
Week 24 (N=29)	0.48 1.4%
Week 36 (N=30)	0.43 1.3%

35. Secondary Outcome

Title	Drug Adherence Assessed as Number of Missed Doses Over a 4-day Recall
Description	Self-reported MVC adherence data were based on a four-day (8 expected doses) recall. Based on the wording of the Self Report case report form (CRF), participants reporting that they were currently taking MVC that then failed to complete the record of the number of missed doses were assumed to have no missed doses to report. Missing adherence assessments at a time point of interest were ignored and only those participants completing an adherence assessment at least one time point of interest were included.
Time Frame	At weeks 4, 12, and 24

Outcome Measure Data

Analysis Population Description

As-treated: Participants who initiated treatment were included. Follow-up while receiving MVC without change in background regimen were included.

Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Measure Participants	33
Week 4 (N=30)	0
Week 12 (N=28)	0
Week 24 (N=27)	0

Adverse Events

Time Frame	From first dose of MVC until off-study
Adverse Event Reporting Description	Grade>=2 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events & other diseases. Grade>=3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
Arm/Group Title	Maraviroc
Arm/Group Description	Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
All Cause Mortality
	Maraviroc
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Maraviroc
	Affected / at Risk (%)	# Events
Total	4/34 (11.8%)
Cardiac disorders
Bradycardia	1/34 (2.9%)
Gastrointestinal disorders
Upper gastrointestinal haemorrhage	1/34 (2.9%)
Infections and infestations
Pneumonia	2/34 (5.9%)
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease	1/34 (2.9%)
Other (Not Including Serious) Adverse Events
	Maraviroc
	Affected / at Risk (%)	# Events
Total	22/34 (64.7%)
Gastrointestinal disorders
Abdominal distension	2/34 (5.9%)
Constipation	2/34 (5.9%)
Diarrhoea	2/34 (5.9%)
General disorders
Fatigue	4/34 (11.8%)
Infections and infestations
Pneumonia bacterial	3/34 (8.8%)
Upper respiratory tract infection	3/34 (8.8%)
Investigations
Alanine aminotransferase increased	2/34 (5.9%)
Aspartate aminotransferase increased	2/34 (5.9%)
Blood albumin abnormal	2/34 (5.9%)
Blood bilirubin increased	5/34 (14.7%)
Blood glucose abnormal	3/34 (8.8%)
Blood glucose increased	4/34 (11.8%)
Blood sodium decreased	3/34 (8.8%)
Neutrophil count decreased	3/34 (8.8%)
Platelet count decreased	3/34 (8.8%)
Musculoskeletal and connective tissue disorders
Pain in extremity	2/34 (5.9%)
Psychiatric disorders
Insomnia	2/34 (5.9%)
Respiratory, thoracic and mediastinal disorders
Cough	5/34 (14.7%)
Respiratory tract congestion	2/34 (5.9%)
Sinus congestion	3/34 (8.8%)
Skin and subcutaneous tissue disorders
Rash	2/34 (5.9%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

In accordance with the Clinical Trial Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights