Status:
COMPLETED
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
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 dr...
Eligibility Criteria
Inclusion
- HIV RNA ≥5000 c/ml
Exclusion
- 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;
- 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.
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
1057 Patients enrolled
Trial Details
Trial ID
NCT00272779
Start Date
November 1 2005
End Date
October 1 2008
Last Update
May 9 2011
Active Locations (79)
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1
Local Institution
Phoenix, Arizona, United States
2
Local Institution
Laguna Beach, California, United States
3
Local Institution
Washington D.C., District of Columbia, United States
4
Local Institution
Fort Lauderdale, Florida, United States