Clinical trial NCT00272779: 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
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: HIV
Treatment Naive
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2006-01-09
Enrollment: 1057
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* HIV RNA ≥5000 c/ml

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.

Primary outcomes:
measure: Number of Participants With Human-immunodeficiency Virus- Ribonucleic Acid (HIV-RNA) < 50 Copies (c)/mL at Week 48
timeFrame: Baseline (Day 1) and Week 48
measure: Maximum Plasma Concentration (Cmax) of ATV/RTV and LPV/RTV in the Presence of an Antiretroviral (ARV) Regimen Including TDF at Week 4
timeFrame: 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.
measure: 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
timeFrame: 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.
measure: Minimum Plasma Concentration (Cmin) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4
timeFrame: 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.
measure: 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
timeFrame: 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.
measure: Terminal Elimination Half-life (T-half) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4
timeFrame: 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.
measure: Protein Binding Adjusted Effective Concentration (EC-90) of ATV and LPV When Dosed With RTV at Week 4
timeFrame: 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.
measure: Inhibitory Quotient (IQ) of ATV and LPV When Dosed With RTV at Week 4
timeFrame: 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.
measure: Cmax of RTV at Week 4
timeFrame: 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.
measure: AUC (0-24) of RTV at Week 4
timeFrame: 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.
measure: Cmin of RTV at Week 4
timeFrame: 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.
measure: Cmax of Tenofovir at Week 4
timeFrame: 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.
measure: Cmin of Tenofovir at Week 4
timeFrame: 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.
measure: AUC (TAU) of Tenofovir at Week 4
timeFrame: 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.
measure: Mean Change From Baseline in Trunk-to-Limb Fat Ratio as Measured by Dual Energy X-ray Absorptiometry (DEXA) at Week 96
timeFrame: Baseline (Day 1) and Week 96.
measure: Number of Participants With Single Nucleotide Polymorphisms (SNPs) Included in Genotype-Phenotype Analysis
timeFrame: Baseline visit
measure: Mean Change From Baseline in Fasting Non-High Density Lipoprotein (HDL) Cholesterol Associated With RETN_097
timeFrame: Baseline (Day 1), Week 48, and Week 96.
measure: Mean Change From Baseline in Fasting Triglycerides Associated With RETN_097
timeFrame: Baseline (Day 1), Week 48, and Week 96.
measure: Mean Change From Baseline in Fasting Triglycerides Associated With RETN_2265
timeFrame: Baseline (Day 1), Week 48, and Week 96.
measure: Mean Change From Baseline in Fasting Triglycerides Associated With RETN_598
timeFrame: Baseline (Day 1), Week 48, and Week 96.
measure: Mean Change From Baseline in Fasting Triglycerides Associated With APOE_C130R
timeFrame: Baseline (Day 1), Week 48, and Week 96.
measure: Mean Change From Baseline in Fasting Triglycerides Associated With RETN_734
timeFrame: Baseline (Day 1), Week 48, and Week 96.
measure: Mean Change From Baseline in Fasting Plasminogen Activator Inhibitor (PAI)-1 Associated With APOE_R176C
timeFrame: Baseline (Day 1), Week 48, and Week 96.
measure: Mean Change From Baseline in Fasting Tumor Necrosis Factor (TNF)-Alpha Associated With IL6_5309
timeFrame: Baseline (Day 1), Week 48, and Week 96.
measure: Mean Change From Baseline in Fasting Tumor Necrosis Factor (TNF)-Alpha Asssociated With RS11030679
timeFrame: Baseline (Day 1), Week 48, and Week 96.
measure: Mean Change From Baseline in Subcutaneous Adipose Tissue (SAT)-To-Trunk Adipose Tissue (TAT) Ratio Associated With CCDC122_5980
timeFrame: Baseline (Day 1), Week 48, and Week 96.
measure: Mean Change From Baseline in Visceral Adipose Tissue (VAT) Associated With BRUNOL_1842
timeFrame: Baseline (Day 1), Week 48, and Week 96.
measure: Mean Change From Baseline in VAT Associated With RETN_730
timeFrame: Baseline (Day 1), Week 48, and Week 96.
measure: Mean Change From Baseline in VAT-to-TAT Ratio Associated With CCDA122_5980
timeFrame: Baseline (Day 1), Week 48, and Week 96.
Secondary outcomes:
measure: Number of Participants With HIV RNA < 400 c/mL at Week 48
timeFrame: Baseline (Day 1) and Week 48
measure: 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)
timeFrame: Baseline (Day 1) and Week 48
measure: Reduction of log10 HIV RNA Levels From Baseline to Week 48
timeFrame: Baseline (Day 1) and Week 48
measure: Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 48
timeFrame: Baseline (Day 1) and Week 48.
measure: Treatment Emergent Resistance in Isolates From Participants With Virologic Failure at Week 48
timeFrame: Baseline (Day 1) and Week 48
measure: Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced AEs Leading to Discontinuation Through Week 48
timeFrame: From baseline (Day 1) to Week 48.
measure: 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)
timeFrame: At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.
measure: Number of Participants With Laboratory Abnormalities in Serum Enzymes Levels Through Week 48
timeFrame: At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.
measure: Number of Participants With Laboratory Abnormalities in Liver Function Test Through Week 48
timeFrame: At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.
measure: Number of Participants With Laboratory Abnormalities in Renal Function Test Through Week 48
timeFrame: At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, and 48.
measure: Number of Participants With Laboratory Abnormalities in Electrolytes Through Week 48
timeFrame: At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.
measure: Number of Participants With Laboratory Abnormalities in Urinalysis Through Week 48
timeFrame: At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.
measure: Number of Participants With Laboratory Abnormalities in Fasting Lipids Through Week 48
timeFrame: At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.
measure: Number of Participants With Laboratory Abnormalities in Fasting Glucose Through Week 48
timeFrame: At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.
measure: Mean Change in Weight From Baseline at Week 48
timeFrame: Baseline (Day 1) and Week 48
measure: Mean Change in Body Mass Index (BMI) in Participants at Week 48
timeFrame: Baseline (Day 1) and Week 48
measure: Mean Change in Fasting Lipid at Week 48
timeFrame: Baseline (Day 1) and Week 48.
measure: Mean Change in Fasting Glucose at Week 48
timeFrame: Baseline (Day 1) and Week 48.
measure: Mean Change in Fasting Insulin at Week 48
timeFrame: Baseline (Day 1) and Week 48.
measure: Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 24
timeFrame: Baseline (Day 1) and Week 24.
measure: Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 48
timeFrame: Baseline (Day 1) and Week 48
measure: Mean Change From Baseline (BL) in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 4 (IBS-QoL)
timeFrame: IBS-QoL is administered at baseline (Day 1) and Week 4.
measure: Mean Change From Baseline in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 12 (IBS-QoL)
timeFrame: IBS-QoL is administered at baseline (Day 1) and Week 12.
measure: 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)
timeFrame: Baseline (Day 1) and Week 24
measure: Number of Participants Who Adhered to Regimen as Measured by Multicenter AIDS Cohort Study Adherence Questionnaire (MACS) at Week 48
timeFrame: Week 48
measure: Number of Participants With HIV RNA < 50 c/mL) at Week 96
timeFrame: Baseline (Day 1) and Week 96
measure: Number of Participants With HIV RNA < 400 c/mL) at Week 96
timeFrame: Baseline (Day 1) and Week 96
measure: Reduction of log10 HIV RNA Levels From Baseline at Week 96
timeFrame: Baseline (Day 1) and Week 96
measure: Mean Change From Baseline in CD4 Cell Count at Week 96
timeFrame: Baseline (Day 1) and Week 96
measure: Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced Events Leading to Discontinuation Through Week 96
timeFrame: From Day 1 through Week 96
measure: Mean Changes in Fasting Lipids at Week 96
timeFrame: At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.
measure: Mean Changes in Fasting Glucose at Week 96
timeFrame: Baseline (Day 1) and Week 96
measure: Mean Changes in Fasting Insulin at Week 96
timeFrame: Baseline (Day 1) and Week 96.
measure: Number of Participants With Laboratory Abnormalities in Hematology: Hemoglobin, Hematocrit, Platelet Count, INR, Neutrophils, PT and WBC Through Week 96
timeFrame: At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.
measure: Number of Participants With Laboratory Abnormalities in Serum Enzyme Levels Through Week 96
timeFrame: At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.
measure: Number of Participants With Laboratory Abnormalities in Liver Function Test Through Week 96
timeFrame: At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.
measure: Number of Participants With Laboratory Abnormalities in Renal Function Test Through Week 96
timeFrame: At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.
measure: Number of Participants With Laboratory Abnormalities in Electrolytes Level Through Week 96
timeFrame: At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.
measure: Number of Participants With Laboratory Abnormalities in Fasting Lipids Level Through Week 96
timeFrame: At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.
measure: Number of Participants With Laboratory Abnormalities in Fasting Glucose Levels Through Week 96
timeFrame: At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.
measure: Number of Participants With Laboratory Abnormalities in Urinalysis Through Week 96
timeFrame: At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.
measure: Number of Participants With Virologic Failure Showing Treatment Emergent Resistance Through Week 96
timeFrame: Baseline (Day 1) and Week 96.
measure: Mean Change From Baseline in Trunk-to-limb Fat Ratio Measured by DEXA at Week 48
timeFrame: DEXA scans were taken at Baseline (Day 1) and at Weeks 48.
measure: Mean Percent Changes From Baseline in Limb, Trunk and Total Body Fat Measured by DEXA at Week 48
timeFrame: DEXA scans were performed at baseline (within 30 days of starting study treatment), and at Weeks 48.
measure: Mean Percent Changes From Baseline in Limb, Trunk and Total Body Fat Measured by DEXA at Week 96
timeFrame: Baseline (Day 1) and Week 96.
measure: 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
timeFrame: Baseline (Day 1) and Week 96.
measure: Mean Percent Changes From Baseline in Bone Mineral Density (BMD) Measured by DEXA at Week 48
timeFrame: DEXA scans were taken at Baseline (Day 1) and Week 48.
measure: Mean Percent Changes From Baseline in BMD Measured by DEXA at Week 96
timeFrame: Baseline (Day 1) and Week 96
measure: Mean Change From Baseline in Body Weight at Week 96
timeFrame: Baseline (Day 1) and Week 96
measure: Mean Change From Baseline in Body Weight at Week 48
timeFrame: Baseline (Day 1) and Week 48
measure: Mean Change From Baseline in BMI at Week 96
timeFrame: Baseline (Day 1) and Week 96
measure: Mean Change From Baseline in Waist Circumference at Week 96
timeFrame: Baseline (Day 1) and Week 96.
measure: Mean Change From Baseline in Waist Circumference at Week 48
timeFrame: Baseline (Day 1) and Week 48
measure: Mean Change From Baseline in Waist-to-hip-ratio at Week 96
timeFrame: Baseline (Day 1) and Week 96
measure: Mean Change From Baseline in BMI at Week 48
timeFrame: Baseline (Day 1) and Week 48.
measure: Mean Change From Baseline in Waist-to-hip-ratio at Week 48
timeFrame: Baseline (Day 1) and Week 48
measure: Percentage of Participants With Lipoatrophy at Week 96
timeFrame: Baseline (Day 1) and Week 96
measure: Mean Changes From Baseline in Body Weight at Week 96
timeFrame: Physical examination was performed at Baseline (Day 1) and Weeks 48 and 96.
measure: Mean Change From Baseline in BMI at Week 96
timeFrame: Baseline (Day 1) and Week 96
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Local Institution
state: Arizona
city: Laguna Beach
country: United States
facility: Local Institution
state: California
city: Washington
country: United States
facility: Local Institution
state: District of Columbia
city: Ft. Lauderdale
country: United States
facility: Local Institution
state: Florida
city: Orlando
country: United States
facility: Local Institution
state: Florida
city: Huntersville
country: United States
facility: Local Institution
state: North Carolina
city: Dallas
country: United States
facility: Local Institution
state: Texas
city: Fort Worth
country: United States
facility: Local Institution
state: Texas
city: Capital Federal
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Mar Del Plata
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Rosario
country: Argentina
facility: Local Institution
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Cordoba
country: Argentina
facility: Local Institution
city: Darlinghurst
country: Australia
facility: Local Institution
state: New South Wales
city: Carlton
country: Australia
facility: Local Institution
state: Victoria
city: South Yarra
country: Australia
facility: Local Institution
state: Victoria
city: Wien
country: Austria
facility: Local Institution
city: Brugge
country: Belgium
facility: Local Institution
city: Gent
country: Belgium
facility: Local Institution
city: Curitiba
country: Brazil
facility: Local Institution
state: Parana
city: Recife
country: Brazil
facility: Local Institution
state: Pernambuco
city: Campinas
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Rio De Janeiro
country: Brazil
facility: Local Institution
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Santiago De Chile
country: Chile
facility: Local Institution
state: Metropolitana
city: Santiago
country: Chile
facility: Local Institution
state: Metropolitana
city: Vina Del Mar
country: Chile
facility: Local Institution
state: Valparaiso
city: Bogota
country: Colombia
facility: Local Institution
city: San Jose
country: Costa Rica
facility: Local Institution
city: Santo Domingo
country: Dominican Republic
facility: Local Institution
city: Nice Cedex
country: France
facility: Local Institution
city: Paris Cedex 10
country: France
facility: Local Institution
city: Paris Cedex 13
country: France
facility: Local Institution
city: Paris Cedex
country: France
facility: Local Institution
city: Villejuif
country: France
facility: Local Institution
city: Berlin
country: Germany
facility: Local Institution
city: Bonn
country: Germany
facility: Local Institution
city: Hamburg
country: Germany
facility: Local Institution
city: Koeln
country: Germany
facility: Local Institution
city: Guatemala
country: Guatemala
facility: Local Institution
city: Kowloon
country: Hong Kong
facility: Local Institution
city: Jakarta
country: Indonesia
facility: Local Institution
city: Genova
country: Italy
facility: Local Institution
city: Milano
country: Italy
facility: Local Institution
city: Roma
country: Italy
facility: Local Institution
city: Torino
country: Italy
facility: Local Institution
city: Mexico
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Zapopal
country: Mexico
facility: Local Institution
state: Jalisco
city: Zapopan
country: Mexico
facility: Local Institution
state: Jalisco
city: Chihuaha
country: Mexico
facility: Local Institution
city: Durango
country: Mexico
facility: Local Institution
city: San Luis Potisi
country: Mexico
facility: Local Institution
city: Maastricht
country: Netherlands
facility: Local Institution
city: Utrecht
country: Netherlands
facility: Local Institution
city: Panama
country: Panama
facility: Local Institution
city: Lima
country: Peru
facility: Local Institution
city: Lisboa
country: Portugal
facility: Local Institution
city: Lisbon
country: Portugal
facility: Local Institution
city: Ponce
country: Puerto Rico
facility: Local Institution
city: San Juan
country: Puerto Rico
facility: Local Institution
city: Singapore
country: Singapore
facility: Local Institution
city: Port Elizabeth
country: South Africa
facility: Local Institution
state: Eastern Cape
city: Bloemfontein
country: South Africa
facility: Local Institution
state: Free State
city: Johannesburg
country: South Africa
facility: Local Institution
state: Gauteng
city: Meadowdale
country: South Africa
facility: Local Institution
state: Gauteng
city: Westdene
country: South Africa
facility: Local Institution
state: Gauteng
city: Durban
country: South Africa
facility: Local Institution
state: Kwa Zulu Natal
city: Mowbray
country: South Africa
facility: Local Institution
state: Western Cape
city: Parow
country: South Africa
facility: Local Institution
state: Western Cape
city: Rugby
country: South Africa
facility: Local Institution
state: Western Cape
city: Barcelona
country: Spain
facility: Local Institution
city: Cordoba
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Malaga
country: Spain
facility: Local Institution
city: Kaohsiung
country: Taiwan
facility: Local Institution
city: Taipei
country: Taiwan
facility: Local Institution
city: Chiang Mai
country: Thailand
facility: Local Institution
city: Khonkaen
country: Thailand
facility: Local Institution
city: London
country: United Kingdom
facility: Local Institution
state: Greater London
city: Manchester
country: United Kingdom
facility: Local Institution
state: Greater Manchester
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: 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.
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