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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
State/province [12] 0 0
Gent
Country [13] 0 0
Brazil
State/province [13] 0 0
Parana
Country [14] 0 0
Brazil
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the safety, tolerability and antiviral effects of atazanavir (ATV) plus ritonavir (RTV) versus a combination drug of lopinavir (LPV) plus RTV. A combination drug containing tenofovir (TDF) and emtricitabine (FTC) will also be taken by participants in both arms.
Trial website
https://clinicaltrials.gov/study/NCT00272779
Trial related presentations / publications
Molina JM, Andrade-Villanueva J, Echevarria J, Chetchotisakd P, Corral J, David N, Moyle G, Mancini M, Percival L, Yang R, Wirtz V, Lataillade M, Absalon J, McGrath D; CASTLE Study Team. Once-daily atazanavir/ritonavir compared with twice-daily lopinavir/ritonavir, each in combination with tenofovir and emtricitabine, for management of antiretroviral-naive HIV-1-infected patients: 96-week efficacy and safety results of the CASTLE study. J Acquir Immune Defic Syndr. 2010 Mar;53(3):323-32. doi: 10.1097/QAI.0b013e3181c990bf.
Molina JM, Andrade-Villanueva J, Echevarria J, Chetchotisakd P, Corral J, David N, Moyle G, Mancini M, Percival L, Yang R, Thiry A, McGrath D; CASTLE Study Team. Once-daily atazanavir/ritonavir versus twice-daily lopinavir/ritonavir, each in combination with tenofovir and emtricitabine, for management of antiretroviral-naive HIV-1-infected patients: 48 week efficacy and safety results of the CASTLE study. Lancet. 2008 Aug 23;372(9639):646-55. doi: 10.1016/S0140-6736(08)61081-8.
Zhu L, Liao S, Child M, Zhang J, Persson A, Sevinsky H, Eley T, Xu X, Krystal M, Farajallah A, McGrath D, Molina JM, Bertz R. Pharmacokinetics and inhibitory quotient of atazanavir/ritonavir versus lopinavir/ritonavir in HIV-infected, treatment-naive patients who participated in the CASTLE Study. J Antimicrob Chemother. 2012 Feb;67(2):465-8. doi: 10.1093/jac/dkr490. Epub 2011 Nov 25.
Uy J, Yang R, Wirtz V, Sheppard L, Farajallah A, McGrath D. Treatment of advanced HIV disease in antiretroviral-naive HIV-1-infected patients receiving once-daily atazanavir/ritonavir or twice-daily lopinavir/ritonavir, each in combination with tenofovir disoproxil fumarate and emtricitabine. AIDS Care. 2011 Nov;23(11):1500-4. doi: 10.1080/09540121.2011.565033. Epub 2011 Jul 7.
Squires KE, Johnson M, Yang R, Uy J, Sheppard L, Absalon J, McGrath D. Comparative gender analysis of the efficacy and safety of atazanavir/ritonavir and lopinavir/ritonavir at 96 weeks in the CASTLE study. J Antimicrob Chemother. 2011 Feb;66(2):363-70. doi: 10.1093/jac/dkq457. Epub 2010 Dec 9.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00272779