Roll-Over Protocol To Provide Atv And/Or Truvada For Extended Access

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01003990
• Collaborator: (none)
• Enrollment: 710
• Locations: 89
• Arms: 3
• Duration (Months): 160
• Patients Per Site: 8
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The purpose of this study is to provide atazanavir or tenofovir-emtricitabine to HIV-infected subjects who have completed atazanavir or tenofovir-emtricitabine therapy on a previous BMS sponsored clinical trial and to collect long-term safety information on the treated population.

Condition or Disease	Intervention/Treatment	Phase
HIV	Drug: Atazanavir; Drug: Atazanavir/Ritonavir; Drug: Tenofovir/Emtricitabine; Drug: Lopinavir/ritonavir	Phase 3

Detailed Description

Provide study drug for patients rolling off BMS ATV clinical trials in countries where these medications are not commercially available.

Study Design

• Study Type: Interventional
• Actual Enrollment: 710 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Atazanavir (BMS-232632) for HIV Infected Individuals Completing Atazanavir Clinical Trials: An Extended Access Study
• Study Start Date: Oct 1, 2002
• Actual Primary Completion Date: Feb 1, 2016
• Actual Study Completion Date: Feb 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Atazanavir	Drug: Atazanavir; Tablets, Oral, 400 mg, once daily, indefinitely; Other Names: Reyataz BMS-232632
Experimental: Atazanavir/Ritonavir	Drug: Atazanavir/Ritonavir; Tablets, Oral, 300/100 mg, once daily, indefinitely; Other Names: Reyataz BMS-232632
Active Comparator: Lopinavir/Ritonavir Ritonavir-boosted Lopinavir (LPV/RTV 400/100 mg) administered twice a day (BID) with Tenofovir/ Emtricitabine (TDF/FTC).	Drug: Tenofovir/Emtricitabine; Tablets, Oral, 300/200 mg, once daily, indefinitely; Other Names: Truvada ; Drug: Lopinavir/ritonavir; Tablets, Oral, 400/100 mg, twice daily, indefinitely

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Serious Adverse Events (SAEs), Treatment Related SAEs, Treatment Related Adverse Events (AEs), AEs Leading to Discontinuation of Study Therapy, Grade 3 to Grade 4 AEs, Grade 3 to Grade 4 AEs, CDC Class C AIDS Events, or Death [Date of First Dose to 30 days post the last dose; approximately 405 weeks)]

   AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. AIDS Defining Diagnosis ( CDC Class C AIDS Events) are identified from HIV Related Diagnosis.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Subjects must provide written informed consent

• Currently receiving atazanavir (unboosted or boosted with 100 mg ritonavir QD)and/or tenofovir-emtricitabine at time of screening and viral load is

≤ 10,000 copies/mL while on therapy

• Subjects who are receiving investigational antiretroviral agents through Expanded Access Programs will be allowed to participate following discussion and approval by the BMS Medical Monitor

• ≥ 16 years of age (or minimum age as determined by local regulatory or as legal requirements dictate)

• Both females of child-bearing potential and males must utilize effective barrier contraception to reduce transmission of sexually transmitted diseases, including HIV. Other contraception in addition to barrier methods are permitted, however interactions between atazanavir and oral contraceptives have not been studied

Exclusion Criteria:

• WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the study

• WOCBP using a prohibited contraceptive method (no contraceptive methods prohibited in this study. However, caution is warranted with coadministration of oral contraceptives)

• Women who are pregnant or breastfeeding

• Women with a positive pregnancy test on enrollment or prior to study drug administration, with the exception of women rolling over from AI424182, who may still have a positive β-HCG test at the time of enrollment

• All subjects previously discontinued from an atazanavir study for any reason

• Active alcohol or substance abuse sufficient, in the Investigator's opinion, to prevent adequate compliance with study therapy or to increase the risk of developing pancreatitis or chemical hepatitis

• Any other clinical conditions or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for study, or unable to comply with the dosing requirements

• Any of the following laboratory values:

• 1. Serum creatinine ≥ 1.5 times the upper limit of normal,
• 1. Liver enzymes (AST, ALT) ≥ 5 times the upper limit of normal,

• Hypersensitivity to any component of the formulation of study drug

• Refer to Section 6.4.1 which details all prohibited therapies

• Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Phoenix Body Positive, Inc	Phoenix	Arizona	United States	85006
2	Rand Schrader Clinic	Los Angeles	California	United States	90033
3	St Francis Memorial Hospital	San Francisco	California	United States	94109
4	Sbma Research, Llc	Miami Beach	Florida	United States	33139
5	St Josephs Cmprhnsv Rsch Inst	Tampa	Florida	United States	33607
6	Infectious Disease Of Indiana, Psc	Indianapolis	Indiana	United States	46218
7	Univ Of Kansas Sch Of Med	Wichita	Kansas	United States	67214
8	Cri Of New England	Boston	Massachusetts	United States	02215
9	University Of Nebraska Medical Center	Omaha	Nebraska	United States	68198
10	Jemsek Clinic	Huntersville	North Carolina	United States	28078
11	Tarrant County Inf Dis Assoc	Fort Worth	Texas	United States	76104
12	The Schrader Clinic	Houston	Texas	United States	77098
13	Local Institution	Rosario	Santa Fe	Argentina	2000
14	Local Institution	Buenos Aires		Argentina	1155
15	Local Institution	Buenos Aires		Argentina	1181
16	Local Institution	Buenos Aires		Argentina	1202
17	Local Institution	Buenos Aires		Argentina	1650
18	Local Institution	Cordoba		Argentina	X5000BJH
19	Local Institution	Curitiba	Parana	Brazil	80060
20	Local Institution	Curitiba	Parana	Brazil	80240
21	Local Institution	Recife	Pernambuco	Brazil	52052
22	Local Institution	Rio De Janeiro - Rj	Rio De Janeiro	Brazil	22271
23	Local Institution	Campinas	Sao Paulo	Brazil	13083
24	Local Institution	Sao Paulo - Sp	Sao Paulo	Brazil	01246
25	Local Institution	Rio De Janeiro		Brazil	21040000
26	Local Institution	Sao Paulo		Brazil	01246
27	Local Institution	Hamilton	Ontario	Canada	L8S 4J9
28	Local Institution	Montreal	Quebec	Canada	H2L 5B1
29	Local Institution	Santiago De Chile	Metropolitana	Chile
30	Local Institution	Santiago	Metropolitana	Chile
31	Local Institution	Bogota	Cundinamarca	Colombia
32	Local Institution	San Jose	Barrio Aranjuez	Costa Rica	1792
33	Local Institution	Santo Domingo		Dominican Republic
34	Local Institution	Le Kremlin Bicetre		France	94275
35	Local Institution	Lyon Cedex 02		France	69288
36	Local Institution	Paris		France	75014
37	Local Institution	Paris		France	75020
38	Local Institution	Tourcoing		France	59208
39	Local Institution	Guatemala		Guatemala	01011
40	Local Institution	Guatemala		Guatemala	01016
41	Local Institution	Guatemala		Guatemala
42	Local Institution	Budapest		Hungary	1097
43	Local Institution	Jakarta		Indonesia	10430
44	Local Institution	Milano		Italy	20127
45	Local Institution	Milano		Italy	20157
46	Local Institution	Modena		Italy	41100
47	Local Institution	Roma		Italy	00185
48	Local Institution	Torino		Italy	10149
49	Local Institution	Kuala Lumpur		Malaysia	50586
50	Local Institution	Kuala Lumpur		Malaysia	59100
51	Local Institution	Mexico	Distrito Federal	Mexico	03100
52	Local Institution	Mexico	Distrito Federal	Mexico	14080
53	Local Institution	Panama		Panama	4746
54	Local Institution	Barranco	Lima	Peru	4
55	Local Institution	Lima		Peru	13
56	Local Institution	Lima		Peru	1
57	Local Institution	Lima		Peru	31
58	Local Institution	Lima		Peru	LIMA 14
59	Local Institution	Lisbon		Portugal	1649-035
60	Local Institution	Porto		Portugal	4200-319
61	Clinical Research Puerto Rico, Inc.	San Juan		Puerto Rico	00909
62	V.A. Medical Center	San Juan		Puerto Rico	00927
63	Local Institution	Moscow		Russian Federation	111123
64	Local Institution	St. Petersburg		Russian Federation	189635
65	Local Institution	St.petersburg		Russian Federation	193167
66	Local Institution	Singapore		Singapore	308433
67	Local Institution	Port Elizabeth	Eastern Cape	South Africa	6001
68	Local Institution	Bloemfontein	Free State	South Africa	9301
69	Local Institution	Johannesburg	Gauteng	South Africa	2013
70	Local Institution	Meadowdale	Gauteng	South Africa	1610
71	Local Institution	Westdene	Gauteng	South Africa	2092
72	Local Institution	Observatory	Western Cape	South Africa	7925
73	Local Institution	Rugby	Western Cape	South Africa	7405
74	Local Institution	Badalona		Spain	08915
75	Local Institution	Barcelona		Spain	08036
76	Local Institution	Bilbao		Spain	48013
77	Local Institution	Cordoba		Spain	14004
78	Local Institution	Madrid		Spain	28029
79	Local Institution	Madrid		Spain	28034
80	Local Institution	Madrid		Spain	28040
81	Local Institution	Madrid		Spain	28046
82	Local Institution	Sevilla		Spain	41013
83	Local Institution	Kaohsiung		Taiwan	813
84	Local Institution	Taipei		Taiwan	100
85	Local Institution	Taipei		Taiwan	108
86	Local Institution	Bangkok		Thailand	10300
87	Local Institution	Bangkok		Thailand	10400
88	Local Institution	Bangkok		Thailand	10700
89	Local Institution	Chiangmai		Thailand	50200

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• BMS clinical trial educational resource

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT01003990
• Other Study ID Numbers: AI424-077
• First Posted: Oct 29, 2009
• Last Update Posted: May 11, 2017
• Last Verified: Apr 1, 2017

• Keywords provided by Bristol-Myers Squibb: Treatment experienced
• Additional relevant MeSH terms: Ritonavir; Lopinavir; Atazanavir Sulfate; Tenofovir; Emtricitabine

Study Results

Participant Flow

Recruitment Details	710 participants were enrolled, 709 were treated. The participant who did not receive treatment was enrolled in error having been assigned to efavirenz in the parent study AI424034 (only subjects assigned to ATV rolled over into AI424077).

Arm/Group Title	Atazanavir (ATV)	Atazanavir/Ritonavir (ATV/RTV)	Lopinavir/Ritonavir (LPV/RTV)
Arm/Group Description	Atazanavir: Tablets, Oral, 400 mg (2 x 200 mg capsules), once daily with food, indefinitely	Ritonavir-boosted Atazanavir (ATV/RTV 300/100 mg). Tablets administered orally once daily (QD) with food, indefinitely. Ritonavir: 100 mg QD Atazanavir: 300 mg QD (3 x 100 mg capsules, or 2 x 150 mg capsules)	Ritonavir-boosted Lopinavir (LPV/RTV 400/100 mg) administered twice a day (BID) with Tenofovir/ Emtricitabine (TDF/FTC). Lopinavir: 400 mg BID Ritonavir: 100 mg BID Tenofovir/Emtricitabine: Tablets, Oral, 300/200 mg, once daily (QD) with food, indefinitely (one tablet with 300 mg - 200 mg QD)
Period Title: Overall Study
STARTED	459	154	96
COMPLETED	367	103	53
NOT COMPLETED	92	51	43

Baseline Characteristics

Arm/Group Title	Atazanavir (ATV)	Atazanavir/Ritonavir (ATV/RTV)	Lopinavir/Ritonavir (LPV/RTV)	Total
Arm/Group Description	Atazanavir: Tablets, Oral, 400 mg (2 x 200 mg capsules), once daily with food, indefinitely	Ritonavir-boosted Atazanavir (ATV/RTV 300/100 mg). Tablets administered orally once daily (QD) with food, indefinitely. Ritonavir: 100 mg QD Atazanavir: 300 mg QD (3 x 100 mg capsules, or 2 x 150 mg capsules)	Ritonavir-boosted Lopinavir (LPV/RTV 400/100 mg) administered twice a day (BID) with Tenofovir/ Emtricitabine (TDF/FTC). Lopinavir: 400 mg BID Ritonavir: 100 mg BID Tenofovir/Emtricitabine: Tablets, Oral, 300/200 mg, once daily (QD) with food, indefinitely (one tablet with 300 mg - 200 mg QD)	Total of all reporting groups
Overall Participants	459	154	96	709
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	36.6 (9.00)	35.9 (8.81)	37.6 (10.16)	36.6 (9.12)
Sex: Female, Male (Count of Participants)
Female	172 37.5%	54 35.1%	30 31.3%	256 36.1%
Male	287 62.5%	100 64.9%	66 68.8%	453 63.9%
Race/Ethnicity, Customized (Count of Participants)
White	158 34.4%	34 22.1%	18 18.8%	210 29.6%
Black or African American	112 24.4%	25 16.2%	2 2.1%	139 19.6%
American Indian/Alaska Native	1 0.2%	0 0%	0 0%	1 0.1%
Asian	53 11.5%	13 8.4%	18 18.8%	84 11.8%
Other	135 29.4%	82 53.2%	58 60.4%	275 38.8%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Serious Adverse Events (SAEs), Treatment Related SAEs, Treatment Related Adverse Events (AEs), AEs Leading to Discontinuation of Study Therapy, Grade 3 to Grade 4 AEs, Grade 3 to Grade 4 AEs, CDC Class C AIDS Events, or Death
Description	AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. AIDS Defining Diagnosis ( CDC Class C AIDS Events) are identified from HIV Related Diagnosis.
Time Frame	Date of First Dose to 30 days post the last dose; approximately 405 weeks)

Outcome Measure Data

Analysis Population Description

All Treated Participants

Arm/Group Title	Atazanavir (ATV)	Atazanavir/Ritonavir (ATV/RTV)	Lopinavir/Ritonavir (LPV/RTV)
Arm/Group Description	Atazanavir: Tablets, Oral, 400 mg (2 x 200 mg capsules), once daily with food, indefinitely	Ritonavir-boosted Atazanavir (ATV/RTV 300/100 mg). Tablets administered orally once daily (QD) with food, indefinitely. Ritonavir: 100 mg QD Atazanavir: 300 mg QD (3 x 100 mg capsules, or 2 x 150 mg capsules)	Ritonavir-boosted Lopinavir (LPV/RTV 400/100 mg) administered twice a day (BID) with Tenofovir/ Emtricitabine (TDF/FTC). Lopinavir: 400 mg BID Ritonavir: 100 mg BID Tenofovir/Emtricitabine: Tablets, Oral, 300/200 mg, once daily (QD) with food, indefinitely (one tablet with 300 mg - 200 mg QD)
Measure Participants	459	154	96
SAEs	35 7.6%	19 12.3%	12 12.5%
Treatment Related SAEs	4 0.9%	1 0.6%	0 0%
Treatment Related AEs of Any Grade	180 39.2%	49 31.8%	34 35.4%
AEs Leading to Discontinuation of Study Therapy	8 1.7%	5 3.2%	11 11.5%
Grade 3 to Grade 4 AEs	72 15.7%	27 17.5%	15 15.6%
Grade 2 to Grade 4 AEs	102 22.2%	28 18.2%	19 19.8%
CDC Class C AIDS Events	2 0.4%	0 0%	0 0%
Deaths	2 0.4%	7 4.5%	1 1%

Adverse Events

Time Frame	Date of first dose to date of last dose plus 30 days; approx. 680 weeks
Adverse Event Reporting Description	All Treated Participants Study Initiated: November 13, 2002 Study Completion: February 16, 2016
Arm/Group Title	Atazanavir (ATV)		Atazanavir/Ritonavir (ATV/RTV)		Lopinavir/Ritonavir (LPV/RTV)
Arm/Group Description	Atazanavir: Tablets, Oral, 400 mg (2 x 200 mg capsules), once daily with food, indefinitely		Ritonavir-boosted Atazanavir (ATV/RTV 300/100 mg). Tablets administered orally once daily (QD) with food, indefinitely. Ritonavir: 100 mg QD; Atazanavir: 300 mg QD (3 x 100 mg capsules, or 2 x 150 mg capsules)		Ritonavir-boosted Lopinavir (LPV/RTV 400/100 mg) administered twice a day (BID) with Tenofovir/ Emtricitabine (TDF/FTC). Lopinavir: 400 mg BID; Ritonavir: 100 mg BID; Tenofovir/Emtricitabine: Tablets, Oral, 300/200 mg, once daily (QD) with food, indefinitely (one tablet with 300 mg - 200 mg QD)
All Cause Mortality
	Atazanavir (ATV)		Atazanavir/Ritonavir (ATV/RTV)		Lopinavir/Ritonavir (LPV/RTV)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/459 (0.4%)		7/154 (4.5%)		1/96 (1%)
Serious Adverse Events
	Atazanavir (ATV)		Atazanavir/Ritonavir (ATV/RTV)		Lopinavir/Ritonavir (LPV/RTV)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	35/459 (7.6%)		19/154 (12.3%)		12/96 (12.5%)
Blood and lymphatic system disorders
Leukaemoid reaction	0/459 (0%)		1/154 (0.6%)		0/96 (0%)
Bicytopenia	1/459 (0.2%)		0/154 (0%)		0/96 (0%)
Pancytopenia	0/459 (0%)		0/154 (0%)		1/96 (1%)
Cardiac disorders
Acute coronary syndrome	1/459 (0.2%)		0/154 (0%)		0/96 (0%)
Ear and labyrinth disorders
Vertigo	2/459 (0.4%)		0/154 (0%)		0/96 (0%)
Gastrointestinal disorders
Vomiting	1/459 (0.2%)		1/154 (0.6%)		0/96 (0%)
Proctitis ulcerative	1/459 (0.2%)		0/154 (0%)		0/96 (0%)
Pancreatitis	0/459 (0%)		1/154 (0.6%)		0/96 (0%)
Anal fistula	1/459 (0.2%)		1/154 (0.6%)		0/96 (0%)
Acute abdomen	1/459 (0.2%)		0/154 (0%)		0/96 (0%)
Gastric ulcer perforation	1/459 (0.2%)		0/154 (0%)		0/96 (0%)
Melaena	1/459 (0.2%)		0/154 (0%)		0/96 (0%)
Haemorrhoidal haemorrhage	0/459 (0%)		1/154 (0.6%)		0/96 (0%)
Haemorrhoids	0/459 (0%)		1/154 (0.6%)		0/96 (0%)
Ileus	1/459 (0.2%)		0/154 (0%)		0/96 (0%)
General disorders
Oedema	0/459 (0%)		1/154 (0.6%)		0/96 (0%)
Pyrexia	0/459 (0%)		0/154 (0%)		1/96 (1%)
Hepatobiliary disorders
Gallbladder polyp	0/459 (0%)		1/154 (0.6%)		0/96 (0%)
Drug-induced liver injury	1/459 (0.2%)		0/154 (0%)		0/96 (0%)
Cholelithiasis	0/459 (0%)		1/154 (0.6%)		0/96 (0%)
Infections and infestations
Pneumonia	1/459 (0.2%)		0/154 (0%)		0/96 (0%)
Cervicitis	0/459 (0%)		1/154 (0.6%)		1/96 (1%)
Herpes zoster	0/459 (0%)		1/154 (0.6%)		0/96 (0%)
Neurosyphilis	0/459 (0%)		0/154 (0%)		1/96 (1%)
Abdominal infection	0/459 (0%)		1/154 (0.6%)		0/96 (0%)
Pyelonephritis	1/459 (0.2%)		0/154 (0%)		0/96 (0%)
Tooth abscess	1/459 (0.2%)		0/154 (0%)		0/96 (0%)
Anal abscess	1/459 (0.2%)		0/154 (0%)		0/96 (0%)
Appendiceal abscess	1/459 (0.2%)		0/154 (0%)		0/96 (0%)
Hepatitis A	1/459 (0.2%)		0/154 (0%)		0/96 (0%)
Influenza	2/459 (0.4%)		0/154 (0%)		0/96 (0%)
Peritonitis	1/459 (0.2%)		0/154 (0%)		0/96 (0%)
Pulmonary tuberculosis	1/459 (0.2%)		0/154 (0%)		0/96 (0%)
Tuberculosis	0/459 (0%)		1/154 (0.6%)		0/96 (0%)
Septic shock	0/459 (0%)		0/154 (0%)		1/96 (1%)
Upper respiratory tract infection	0/459 (0%)		1/154 (0.6%)		0/96 (0%)
Bacteraemia	1/459 (0.2%)		0/154 (0%)		0/96 (0%)
Cellulitis	1/459 (0.2%)		0/154 (0%)		0/96 (0%)
Infective tenosynovitis	0/459 (0%)		0/154 (0%)		1/96 (1%)
Appendicitis	1/459 (0.2%)		1/154 (0.6%)		1/96 (1%)
Extrapulmonary tuberculosis	1/459 (0.2%)		0/154 (0%)		0/96 (0%)
Mastoiditis	0/459 (0%)		0/154 (0%)		1/96 (1%)
Injury, poisoning and procedural complications
Accidental exposure to product	0/459 (0%)		1/154 (0.6%)		0/96 (0%)
Limb traumatic amputation	0/459 (0%)		0/154 (0%)		1/96 (1%)
Spinal fracture	1/459 (0.2%)		0/154 (0%)		0/96 (0%)
Open fracture	0/459 (0%)		0/154 (0%)		1/96 (1%)
Traumatic ulcer	1/459 (0.2%)		0/154 (0%)		0/96 (0%)
Humerus fracture	1/459 (0.2%)		0/154 (0%)		0/96 (0%)
Thermal burn	0/459 (0%)		0/154 (0%)		1/96 (1%)
Limb injury	1/459 (0.2%)		0/154 (0%)		0/96 (0%)
Contusion	1/459 (0.2%)		0/154 (0%)		0/96 (0%)
Metabolism and nutrition disorders
Diabetes mellitus	1/459 (0.2%)		0/154 (0%)		0/96 (0%)
Musculoskeletal and connective tissue disorders
Tenosynovitis	0/459 (0%)		0/154 (0%)		1/96 (1%)
Osteonecrosis	1/459 (0.2%)		0/154 (0%)		0/96 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts	1/459 (0.2%)		0/154 (0%)		0/96 (0%)
Lipoma	1/459 (0.2%)		0/154 (0%)		0/96 (0%)
Uterine leiomyoma	1/459 (0.2%)		2/154 (1.3%)		1/96 (1%)
Colon neoplasm	1/459 (0.2%)		0/154 (0%)		0/96 (0%)
Invasive ductal breast carcinoma	0/459 (0%)		1/154 (0.6%)		0/96 (0%)
Colon cancer	1/459 (0.2%)		0/154 (0%)		0/96 (0%)
Hodgkin's disease nodular sclerosis	0/459 (0%)		0/154 (0%)		1/96 (1%)
Testicular neoplasm	1/459 (0.2%)		0/154 (0%)		0/96 (0%)
Cervix carcinoma stage 0	1/459 (0.2%)		0/154 (0%)		0/96 (0%)
Nervous system disorders
Somnolence	0/459 (0%)		0/154 (0%)		1/96 (1%)
Headache	0/459 (0%)		1/154 (0.6%)		0/96 (0%)
Syncope	1/459 (0.2%)		0/154 (0%)		0/96 (0%)
Dizziness	1/459 (0.2%)		0/154 (0%)		0/96 (0%)
Pregnancy, puerperium and perinatal conditions
Abortion incomplete	0/459 (0%)		1/154 (0.6%)		0/96 (0%)
Abortion	1/459 (0.2%)		0/154 (0%)		0/96 (0%)
Ectopic pregnancy	2/459 (0.4%)		0/154 (0%)		0/96 (0%)
Psychiatric disorders
Depression	1/459 (0.2%)		0/154 (0%)		0/96 (0%)
Major depression	2/459 (0.4%)		0/154 (0%)		0/96 (0%)
Suicide attempt	1/459 (0.2%)		0/154 (0%)		1/96 (1%)
Acute psychosis	1/459 (0.2%)		0/154 (0%)		0/96 (0%)
Bipolar disorder	0/459 (0%)		1/154 (0.6%)		0/96 (0%)
Renal and urinary disorders
Renal failure	0/459 (0%)		0/154 (0%)		1/96 (1%)
Nephrolithiasis	1/459 (0.2%)		1/154 (0.6%)		0/96 (0%)
Reproductive system and breast disorders
Dysfunctional uterine bleeding	0/459 (0%)		2/154 (1.3%)		0/96 (0%)
Uterine disorder	0/459 (0%)		1/154 (0.6%)		0/96 (0%)
Cervical dysplasia	0/459 (0%)		1/154 (0.6%)		1/96 (1%)
Endometrial hypertrophy	0/459 (0%)		1/154 (0.6%)		0/96 (0%)
Respiratory, thoracic and mediastinal disorders
Respiratory failure	0/459 (0%)		0/154 (0%)		1/96 (1%)
Asthma	1/459 (0.2%)		0/154 (0%)		0/96 (0%)
Asphyxia	0/459 (0%)		1/154 (0.6%)		0/96 (0%)
Nasal septum deviation	0/459 (0%)		0/154 (0%)		1/96 (1%)
Vascular disorders
Deep vein thrombosis	1/459 (0.2%)		0/154 (0%)		0/96 (0%)
Other (Not Including Serious) Adverse Events
	Atazanavir (ATV)		Atazanavir/Ritonavir (ATV/RTV)		Lopinavir/Ritonavir (LPV/RTV)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	284/459 (61.9%)		92/154 (59.7%)		57/96 (59.4%)
Eye disorders
Ocular icterus	31/459 (6.8%)		4/154 (2.6%)		0/96 (0%)
Gastrointestinal disorders
Diarrhoea	47/459 (10.2%)		22/154 (14.3%)		12/96 (12.5%)
Abdominal pain upper	13/459 (2.8%)		2/154 (1.3%)		6/96 (6.3%)
Abdominal pain	20/459 (4.4%)		8/154 (5.2%)		4/96 (4.2%)
Gastritis	12/459 (2.6%)		8/154 (5.2%)		3/96 (3.1%)
Nausea	19/459 (4.1%)		4/154 (2.6%)		5/96 (5.2%)
General disorders
Pyrexia	12/459 (2.6%)		9/154 (5.8%)		3/96 (3.1%)
Hepatobiliary disorders
Hyperbilirubinaemia	45/459 (9.8%)		3/154 (1.9%)		1/96 (1%)
Jaundice	24/459 (5.2%)		5/154 (3.2%)		1/96 (1%)
Infections and infestations
Nasopharyngitis	51/459 (11.1%)		32/154 (20.8%)		24/96 (25%)
Urinary tract infection	11/459 (2.4%)		11/154 (7.1%)		2/96 (2.1%)
Influenza	32/459 (7%)		16/154 (10.4%)		6/96 (6.3%)
Upper respiratory tract infection	74/459 (16.1%)		10/154 (6.5%)		4/96 (4.2%)
Bronchitis	32/459 (7%)		8/154 (5.2%)		6/96 (6.3%)
Investigations
Alanine aminotransferase increased	27/459 (5.9%)		5/154 (3.2%)		3/96 (3.1%)
Creatinine renal clearance decreased	0/459 (0%)		16/154 (10.4%)		8/96 (8.3%)
Blood bilirubin increased	34/459 (7.4%)		3/154 (1.9%)		1/96 (1%)
Blood cholesterol increased	0/459 (0%)		4/154 (2.6%)		7/96 (7.3%)
Metabolism and nutrition disorders
Hypertriglyceridaemia	6/459 (1.3%)		7/154 (4.5%)		12/96 (12.5%)
Musculoskeletal and connective tissue disorders
Back pain	27/459 (5.9%)		13/154 (8.4%)		12/96 (12.5%)
Arthralgia	21/459 (4.6%)		12/154 (7.8%)		5/96 (5.2%)
Nervous system disorders
Headache	37/459 (8.1%)		15/154 (9.7%)		8/96 (8.3%)
Respiratory, thoracic and mediastinal disorders
Cough	12/459 (2.6%)		7/154 (4.5%)		6/96 (6.3%)
Asthma	4/459 (0.9%)		1/154 (0.6%)		6/96 (6.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.