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

Conditions: HIV Infections

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.

Keywords: hiv treatment naive