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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00272779




Registration number
NCT00272779
Ethics application status
Date submitted
5/01/2006
Date registered
9/01/2006
Date last updated
9/05/2011

Titles & IDs
Public title
BMS-Reyataz Study in Treatment in Naive Subjects to Compare the Efficacy and Safety Between Boosted Reyataz and Kaletra When in Combination With Fixed Dose Truvada
Scientific title
A 96 Week Study Comparing the Antiviral Efficacy and Safety of Atazanavir/Ritonavir With Lopinavir/Ritonavir, Each in Combination With Fixed Dose Tenofovir-Emtricitabine in HIV-1 Infected Treatment in Naive Subjects
Secondary ID [1] 0 0
AI424-138
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ATV
Treatment: Drugs - RTV
Treatment: Drugs - Tenofovi-Emtricitabine (TDF/FTC) tablet
Treatment: Drugs - LPV

Active comparator: Atazanavir (ATV) + Ritonovir (RTV) - Participants were administered an oral dose of ATV 300 mg and RTV 100 mg once daily along with food on a background of fixed dose combination TDF 300 mg plus FTC 200 mg (TDF/FTC) once daily. Doses of ATV and RTV were taken 24 hours apart at the same time as the background TDF/FTC, up to 96 Weeks.

Active comparator: Lopinavir (LPV) + RTV - Participants were administered an oral dose of LPV 400 mg and RTV 100 mg once daily along with food on a background of fixed dose combination TDF 300 mg plus FTC 200 mg (TDF/FTC) once daily. Doses of LPV and RTV were taken 24 hours apart at the same time as the background TDF/FTC, up to 96 Weeks.


Treatment: Drugs: ATV
300mg Oral capsules for 96 weeks

Treatment: Drugs: RTV
100mg Oral Capsules for 96 weeks

Treatment: Drugs: Tenofovi-Emtricitabine (TDF/FTC) tablet
One tablet with 300 mg - 200 mg once a day for 96 weeks.

Treatment: Drugs: LPV
400 mg (3 133mg capsules) BID for 96 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Human-immunodeficiency Virus- Ribonucleic Acid (HIV-RNA) < 50 Copies (c)/mL at Week 48
Timepoint [1] 0 0
Baseline (Day 1) and Week 48
Primary outcome [2] 0 0
Maximum Plasma Concentration (Cmax) of ATV/RTV and LPV/RTV in the Presence of an Antiretroviral (ARV) Regimen Including TDF at Week 4
Timepoint [2] 0 0
Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given every day (QD) and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given twice daily (BID) and TDF given QD.
Primary outcome [3] 0 0
Area Under the Concentration-time Curve, in One Dosing Interval [AUC(TAU)] of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4
Timepoint [3] 0 0
Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.
Primary outcome [4] 0 0
Minimum Plasma Concentration (Cmin) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4
Timepoint [4] 0 0
Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.
Primary outcome [5] 0 0
Time to Reach Maximum Observed Plasma Concentration (Tmax) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4
Timepoint [5] 0 0
Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.
Primary outcome [6] 0 0
Terminal Elimination Half-life (T-half) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4
Timepoint [6] 0 0
Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.
Primary outcome [7] 0 0
Protein Binding Adjusted Effective Concentration (EC-90) of ATV and LPV When Dosed With RTV at Week 4
Timepoint [7] 0 0
Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.
Primary outcome [8] 0 0
Inhibitory Quotient (IQ) of ATV and LPV When Dosed With RTV at Week 4
Timepoint [8] 0 0
Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.
Primary outcome [9] 0 0
Cmax of RTV at Week 4
Timepoint [9] 0 0
Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.
Primary outcome [10] 0 0
AUC (0-24) of RTV at Week 4
Timepoint [10] 0 0
Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.
Primary outcome [11] 0 0
Cmin of RTV at Week 4
Timepoint [11] 0 0
Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.
Primary outcome [12] 0 0
Cmax of Tenofovir at Week 4
Timepoint [12] 0 0
Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.
Primary outcome [13] 0 0
Cmin of Tenofovir at Week 4
Timepoint [13] 0 0
Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.
Primary outcome [14] 0 0
AUC (TAU) of Tenofovir at Week 4
Timepoint [14] 0 0
Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.
Primary outcome [15] 0 0
Mean Change From Baseline in Trunk-to-Limb Fat Ratio as Measured by Dual Energy X-ray Absorptiometry (DEXA) at Week 96
Timepoint [15] 0 0
Baseline (Day 1) and Week 96.
Primary outcome [16] 0 0
Number of Participants With Single Nucleotide Polymorphisms (SNPs) Included in Genotype-Phenotype Analysis
Timepoint [16] 0 0
Baseline visit
Primary outcome [17] 0 0
Mean Change From Baseline in Fasting Non-High Density Lipoprotein (HDL) Cholesterol Associated With RETN_097
Timepoint [17] 0 0
Baseline (Day 1), Week 48, and Week 96.
Primary outcome [18] 0 0
Mean Change From Baseline in Fasting Triglycerides Associated With RETN_097
Timepoint [18] 0 0
Baseline (Day 1), Week 48, and Week 96.
Primary outcome [19] 0 0
Mean Change From Baseline in Fasting Triglycerides Associated With RETN_2265
Timepoint [19] 0 0
Baseline (Day 1), Week 48, and Week 96.
Primary outcome [20] 0 0
Mean Change From Baseline in Fasting Triglycerides Associated With RETN_598
Timepoint [20] 0 0
Baseline (Day 1), Week 48, and Week 96.
Primary outcome [21] 0 0
Mean Change From Baseline in Fasting Triglycerides Associated With APOE_C130R
Timepoint [21] 0 0
Baseline (Day 1), Week 48, and Week 96.
Primary outcome [22] 0 0
Mean Change From Baseline in Fasting Triglycerides Associated With RETN_734
Timepoint [22] 0 0
Baseline (Day 1), Week 48, and Week 96.
Primary outcome [23] 0 0
Mean Change From Baseline in Fasting Plasminogen Activator Inhibitor (PAI)-1 Associated With APOE_R176C
Timepoint [23] 0 0
Baseline (Day 1), Week 48, and Week 96.
Primary outcome [24] 0 0
Mean Change From Baseline in Fasting Tumor Necrosis Factor (TNF)-Alpha Associated With IL6_5309
Timepoint [24] 0 0
Baseline (Day 1), Week 48, and Week 96.
Primary outcome [25] 0 0
Mean Change From Baseline in Fasting Tumor Necrosis Factor (TNF)-Alpha Asssociated With RS11030679
Timepoint [25] 0 0
Baseline (Day 1), Week 48, and Week 96.
Primary outcome [26] 0 0
Mean Change From Baseline in Subcutaneous Adipose Tissue (SAT)-To-Trunk Adipose Tissue (TAT) Ratio Associated With CCDC122_5980
Timepoint [26] 0 0
Baseline (Day 1), Week 48, and Week 96.
Primary outcome [27] 0 0
Mean Change From Baseline in Visceral Adipose Tissue (VAT) Associated With BRUNOL_1842
Timepoint [27] 0 0
Baseline (Day 1), Week 48, and Week 96.
Primary outcome [28] 0 0
Mean Change From Baseline in VAT Associated With RETN_730
Timepoint [28] 0 0
Baseline (Day 1), Week 48, and Week 96.
Primary outcome [29] 0 0
Mean Change From Baseline in VAT-to-TAT Ratio Associated With CCDA122_5980
Timepoint [29] 0 0
Baseline (Day 1), Week 48, and Week 96.
Secondary outcome [1] 0 0
Number of Participants With HIV RNA < 400 c/mL at Week 48
Timepoint [1] 0 0
Baseline (Day 1) and Week 48
Secondary outcome [2] 0 0
Number of Participants With Confirmed Plasma HIV RNA < 400 c/mL at Week 48 (Defined by the Food and Drug Administration [FDA] Time to Loss of Virologic Response [TLOVR] Algorithm)
Timepoint [2] 0 0
Baseline (Day 1) and Week 48
Secondary outcome [3] 0 0
Reduction of log10 HIV RNA Levels From Baseline to Week 48
Timepoint [3] 0 0
Baseline (Day 1) and Week 48
Secondary outcome [4] 0 0
Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 48
Timepoint [4] 0 0
Baseline (Day 1) and Week 48.
Secondary outcome [5] 0 0
Treatment Emergent Resistance in Isolates From Participants With Virologic Failure at Week 48
Timepoint [5] 0 0
Baseline (Day 1) and Week 48
Secondary outcome [6] 0 0
Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced AEs Leading to Discontinuation Through Week 48
Timepoint [6] 0 0
From baseline (Day 1) to Week 48.
Secondary outcome [7] 0 0
Number of Participants With Laboratory Abnormalities in Hematology Through Week 48: Hemoglobin, Hematocrit, Platelet Count, International Normalized Ratio (INR), Neutrophils, Prothrombin Time (PT) and White Blood Cells (WBC)
Timepoint [7] 0 0
At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.
Secondary outcome [8] 0 0
Number of Participants With Laboratory Abnormalities in Serum Enzymes Levels Through Week 48
Timepoint [8] 0 0
At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.
Secondary outcome [9] 0 0
Number of Participants With Laboratory Abnormalities in Liver Function Test Through Week 48
Timepoint [9] 0 0
At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.
Secondary outcome [10] 0 0
Number of Participants With Laboratory Abnormalities in Renal Function Test Through Week 48
Timepoint [10] 0 0
At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, and 48.
Secondary outcome [11] 0 0
Number of Participants With Laboratory Abnormalities in Electrolytes Through Week 48
Timepoint [11] 0 0
At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.
Secondary outcome [12] 0 0
Number of Participants With Laboratory Abnormalities in Urinalysis Through Week 48
Timepoint [12] 0 0
At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.
Secondary outcome [13] 0 0
Number of Participants With Laboratory Abnormalities in Fasting Lipids Through Week 48
Timepoint [13] 0 0
At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.
Secondary outcome [14] 0 0
Number of Participants With Laboratory Abnormalities in Fasting Glucose Through Week 48
Timepoint [14] 0 0
At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.
Secondary outcome [15] 0 0
Mean Change in Weight From Baseline at Week 48
Timepoint [15] 0 0
Baseline (Day 1) and Week 48
Secondary outcome [16] 0 0
Mean Change in Body Mass Index (BMI) in Participants at Week 48
Timepoint [16] 0 0
Baseline (Day 1) and Week 48
Secondary outcome [17] 0 0
Mean Change in Fasting Lipid at Week 48
Timepoint [17] 0 0
Baseline (Day 1) and Week 48.
Secondary outcome [18] 0 0
Mean Change in Fasting Glucose at Week 48
Timepoint [18] 0 0
Baseline (Day 1) and Week 48.
Secondary outcome [19] 0 0
Mean Change in Fasting Insulin at Week 48
Timepoint [19] 0 0
Baseline (Day 1) and Week 48.
Secondary outcome [20] 0 0
Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 24
Timepoint [20] 0 0
Baseline (Day 1) and Week 24.
Secondary outcome [21] 0 0
Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 48
Timepoint [21] 0 0
Baseline (Day 1) and Week 48
Secondary outcome [22] 0 0
Mean Change From Baseline (BL) in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 4 (IBS-QoL)
Timepoint [22] 0 0
IBS-QoL is administered at baseline (Day 1) and Week 4.
Secondary outcome [23] 0 0
Mean Change From Baseline in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 12 (IBS-QoL)
Timepoint [23] 0 0
IBS-QoL is administered at baseline (Day 1) and Week 12.
Secondary outcome [24] 0 0
Mean Change From Baseline in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 24 Using the Irritable Bowel Syndrome Quality of Life (IBS-QoL)
Timepoint [24] 0 0
Baseline (Day 1) and Week 24
Secondary outcome [25] 0 0
Number of Participants Who Adhered to Regimen as Measured by Multicenter AIDS Cohort Study Adherence Questionnaire (MACS) at Week 48
Timepoint [25] 0 0
Week 48
Secondary outcome [26] 0 0
Number of Participants With HIV RNA < 50 c/mL) at Week 96
Timepoint [26] 0 0
Baseline (Day 1) and Week 96
Secondary outcome [27] 0 0
Number of Participants With HIV RNA < 400 c/mL) at Week 96
Timepoint [27] 0 0
Baseline (Day 1) and Week 96
Secondary outcome [28] 0 0
Reduction of log10 HIV RNA Levels From Baseline at Week 96
Timepoint [28] 0 0
Baseline (Day 1) and Week 96
Secondary outcome [29] 0 0
Mean Change From Baseline in CD4 Cell Count at Week 96
Timepoint [29] 0 0
Baseline (Day 1) and Week 96
Secondary outcome [30] 0 0
Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced Events Leading to Discontinuation Through Week 96
Timepoint [30] 0 0
From Day 1 through Week 96
Secondary outcome [31] 0 0
Mean Changes in Fasting Lipids at Week 96
Timepoint [31] 0 0
At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.
Secondary outcome [32] 0 0
Mean Changes in Fasting Glucose at Week 96
Timepoint [32] 0 0
Baseline (Day 1) and Week 96
Secondary outcome [33] 0 0
Mean Changes in Fasting Insulin at Week 96
Timepoint [33] 0 0
Baseline (Day 1) and Week 96.
Secondary outcome [34] 0 0
Number of Participants With Laboratory Abnormalities in Hematology: Hemoglobin, Hematocrit, Platelet Count, INR, Neutrophils, PT and WBC Through Week 96
Timepoint [34] 0 0
At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.
Secondary outcome [35] 0 0
Number of Participants With Laboratory Abnormalities in Serum Enzyme Levels Through Week 96
Timepoint [35] 0 0
At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.
Secondary outcome [36] 0 0
Number of Participants With Laboratory Abnormalities in Liver Function Test Through Week 96
Timepoint [36] 0 0
At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.
Secondary outcome [37] 0 0
Number of Participants With Laboratory Abnormalities in Renal Function Test Through Week 96
Timepoint [37] 0 0
At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.
Secondary outcome [38] 0 0
Number of Participants With Laboratory Abnormalities in Electrolytes Level Through Week 96
Timepoint [38] 0 0
At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.
Secondary outcome [39] 0 0
Number of Participants With Laboratory Abnormalities in Fasting Lipids Level Through Week 96
Timepoint [39] 0 0
At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.
Secondary outcome [40] 0 0
Number of Participants With Laboratory Abnormalities in Fasting Glucose Levels Through Week 96
Timepoint [40] 0 0
At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.
Secondary outcome [41] 0 0
Number of Participants With Laboratory Abnormalities in Urinalysis Through Week 96
Timepoint [41] 0 0
At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.
Secondary outcome [42] 0 0
Number of Participants With Virologic Failure Showing Treatment Emergent Resistance Through Week 96
Timepoint [42] 0 0
Baseline (Day 1) and Week 96.
Secondary outcome [43] 0 0
Mean Change From Baseline in Trunk-to-limb Fat Ratio Measured by DEXA at Week 48
Timepoint [43] 0 0
DEXA scans were taken at Baseline (Day 1) and at Weeks 48.
Secondary outcome [44] 0 0
Mean Percent Changes From Baseline in Limb, Trunk and Total Body Fat Measured by DEXA at Week 48
Timepoint [44] 0 0
DEXA scans were performed at baseline (within 30 days of starting study treatment), and at Weeks 48.
Secondary outcome [45] 0 0
Mean Percent Changes From Baseline in Limb, Trunk and Total Body Fat Measured by DEXA at Week 96
Timepoint [45] 0 0
Baseline (Day 1) and Week 96.
Secondary outcome [46] 0 0
Median Changes From Baseline at Week 96 in VAT-to-TAT, VAT-to-SAT and, Trunk-to-limb Fat Ratio Measured by Computed Tomography (CT)/DEXA
Timepoint [46] 0 0
Baseline (Day 1) and Week 96.
Secondary outcome [47] 0 0
Mean Percent Changes From Baseline in Bone Mineral Density (BMD) Measured by DEXA at Week 48
Timepoint [47] 0 0
DEXA scans were taken at Baseline (Day 1) and Week 48.
Secondary outcome [48] 0 0
Mean Percent Changes From Baseline in BMD Measured by DEXA at Week 96
Timepoint [48] 0 0
Baseline (Day 1) and Week 96
Secondary outcome [49] 0 0
Mean Change From Baseline in Body Weight at Week 96
Timepoint [49] 0 0
Baseline (Day 1) and Week 96
Secondary outcome [50] 0 0
Mean Change From Baseline in Body Weight at Week 48
Timepoint [50] 0 0
Baseline (Day 1) and Week 48
Secondary outcome [51] 0 0
Mean Change From Baseline in BMI at Week 96
Timepoint [51] 0 0
Baseline (Day 1) and Week 96
Secondary outcome [52] 0 0
Mean Change From Baseline in Waist Circumference at Week 96
Timepoint [52] 0 0
Baseline (Day 1) and Week 96.
Secondary outcome [53] 0 0
Mean Change From Baseline in Waist Circumference at Week 48
Timepoint [53] 0 0
Baseline (Day 1) and Week 48
Secondary outcome [54] 0 0
Mean Change From Baseline in Waist-to-hip-ratio at Week 96
Timepoint [54] 0 0
Baseline (Day 1) and Week 96
Secondary outcome [55] 0 0
Mean Change From Baseline in BMI at Week 48
Timepoint [55] 0 0
Baseline (Day 1) and Week 48.
Secondary outcome [56] 0 0
Mean Change From Baseline in Waist-to-hip-ratio at Week 48
Timepoint [56] 0 0
Baseline (Day 1) and Week 48
Secondary outcome [57] 0 0
Percentage of Participants With Lipoatrophy at Week 96
Timepoint [57] 0 0
Baseline (Day 1) and Week 96
Secondary outcome [58] 0 0
Mean Changes From Baseline in Body Weight at Week 96
Timepoint [58] 0 0
Physical examination was performed at Baseline (Day 1) and Weeks 48 and 96.
Secondary outcome [59] 0 0
Mean Change From Baseline in BMI at Week 96
Timepoint [59] 0 0
Baseline (Day 1) and Week 96

Eligibility
Key inclusion criteria
* HIV RNA =5000 c/ml
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Any antiretroviral therapy within 30 days prior to screening;
* Women of Childbearing potential (WOCBP) unwilling or unable to use an acceptable method to avoid pregnancy for the entire study and for up to 8 weeks after the study;
* WOCBP using a prohibited contraceptive method
* WOCBP who are pregnant or breastfeeding;
* Women with a positive pregnancy test on enrollment or prior to study drug administration;
* Presence of a newly diagnosed HIV-Related opportunistic infection or any medical condition requiring acute therapy at the time of enrollment;
* Suspected primary (acute) HIV infection;
* Prior antiviral therapy (>30 days of NRTI and/or >7 days of non-nucleoside reverse transcriptase inhibitor (NNRTI) or PI therapies) or any antiretroviral therapy within 30 days prior to screening; some exceptions are allowed for ARV therapy in use for Mother-to-child transmission;
* Participants with Cushing's syndrome;
* Untreated hypothyroidism or hyperthyroidism. A participant who is euthyroid on a stable replacement dose of thyroid hormone is acceptable provided the thyroid stimulating hormone (TSH) performed within 30 days of screening is within normal drug range;
* Recent therapy with agents with significant systemic myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic or cytotoxic potential within 3 months of study start or expected need for such therapy at the time of enrollment; or therapy with methadone or ribavirin/interferons or treatment with neurotoxic drugs or drugs that affect CYP3A4;
* Participants with obstructive liver disease;
* Active alcohol or substance use sufficient, in the Investigator's opinion, to prevent adequate compliance with study therapy or to increase the risk of developing pancreatitis or chemical hepatitis;
* Proven or suspected acute hepatitis in the 30 days prior to study entry;
* Intractable diarrhea (=6 loose stools/day for at least 7 consecutive days) within 30 days prior to study entry;
* Inability to swallow capsules;
* Active peripheral neuropathy;
* Presence of cardiomyopathy (due to any cause) or any significant cardiovascular disease, such as unstable ischemic heart disease;
* Known, clinically significant cardiac conduction system disease.
* Baseline laboratory values measured within 2 weeks prior to initiating study drugs as follows:

1. calculated creatine clearance <60 mL/min as estimated by the Cockcroft-Gault equation;
2. total serum lipase = 1.4 times the upper limit of normal;
3. liver enzymes (AST, ALT) = 5 times the upper limit of normal;
4. total serum bilirubin = 1.5 times the upper limit of normal.
* Hypersensitivity to any component of the formulation of study drug;
* Prohibited therapies;
* Any other clinical conditions or prior therapy that, in the opinion of the Investigator, would make the participant unsuitable for study or unable to comply with the dosing requirements;
* Prisoners or participants 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2008
Sample size
Target
Accrual to date
Final
1057
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Local Institution - Darlinghurst
Recruitment hospital [2] 0 0
Local Institution - Carlton
Recruitment hospital [3] 0 0
Local Institution - South Yarra
Recruitment postcode(s) [1] 0 0
- Darlinghurst
Recruitment postcode(s) [2] 0 0
- Carlton
Recruitment postcode(s) [3] 0 0
- South Yarra
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
Argentina
State/province [7] 0 0
Buenos Aires
Country [8] 0 0
Argentina
State/province [8] 0 0
Santa Fe
Country [9] 0 0
Argentina
State/province [9] 0 0
Cordoba
Country [10] 0 0
Austria
State/province [10] 0 0
Wien
Country [11] 0 0
Belgium
State/province [11] 0 0
Brugge
Country [12] 0 0
Belgium
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Gent
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Brazil
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Pernambuco
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Brazil
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Brazil
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Rio De Janeiro
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Canada
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Ontario
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Canada
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Quebec
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Chile
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Metropolitana
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Chile
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Valparaiso
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Bogota
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San Jose
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Dominican Republic
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Santo Domingo
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France
State/province [24] 0 0
Nice Cedex
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France
State/province [25] 0 0
Paris Cedex 10
Country [26] 0 0
France
State/province [26] 0 0
Paris Cedex 13
Country [27] 0 0
France
State/province [27] 0 0
Paris Cedex
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France
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Villejuif
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Germany
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Germany
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Bonn
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Germany
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Hamburg
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Germany
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Koeln
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Guatemala
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Kowloon
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Jakarta
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Milano
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Spain
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Spain
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Chiang Mai
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United Kingdom
State/province [68] 0 0
Greater Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00272779