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

Completed · Phase 3

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00272779

Run by

Bristol-Myers Squibb

People needed

1057

Starts

2005-11-01

Expected to finish

2008-10-01

Last updated by the study team

2011-05-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• HIV RNA ≥5000 c/ml

You may not qualify if…

• 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:
• calculated creatine clearance <60 mL/min as estimated by the Cockcroft-Gault equation;
• total serum lipase ≥ 1.4 times the upper limit of normal;
• liver enzymes (AST, ALT) ≥ 5 times the upper limit of normal;
• total serum bilirubin ≥ 1.5 times the upper limit of normal.
• Hypersensitivity to any component of the formulation of study drug;

Where it is running

• Local Institution — Laguna Beach, California, United States
• Local Institution — Washington D.C., District of Columbia, United States
• Local Institution — Fort Lauderdale, Florida, United States
• Local Institution — Orlando, Florida, United States
• Local Institution — Huntersville, North Carolina, United States
• Local Institution — Dallas, Texas, United States
• Local Institution — Fort Worth, Texas, United States
• Local Institution — Capital Federal, Buenos Aires, Argentina
• Local Institution — Mar del Plata, Buenos Aires, Argentina
• Local Institution — Rosario, Santa Fe Province, Argentina
• Local Institution — Buenos Aires, Argentina
• Local Institution — Córdoba, Argentina
• Local Institution — Darlinghurst, New South Wales, Australia
• Local Institution — Carlton, Victoria, Australia
• Local Institution — South Yarra, Victoria, Australia
• Local Institution — Vienna, Austria
• Local Institution — Bruges, Belgium
• Local Institution — Ghent, Belgium
• Local Institution — Curitiba, Paraná, Brazil
• Local Institution — Recife, Pernambuco, Brazil
• Local Institution — Campinas, São Paulo, Brazil
• Local Institution — Rio de Janeiro, Brazil
• Local Institution — São Paulo, Brazil
• Local Institution — Toronto, Ontario, Canada
• Local Institution — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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