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
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.