Status:
COMPLETED
Tenofovir Disoproxil Fumarate/Emtricitabine/Efavirenz Versus Combivir/Efavirenz in Antiretroviral-Naive HIV-1 Infected Subjects
Lead Sponsor:
Gilead Sciences
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of Study GS-01-934 was to assess the efficacy and safety of two simplified antiretroviral treatment (ART) regimens in ART-naive, human immunodeficiency virus, type 1 (HIV-1) infected parti...
Detailed Description
This study was originally planned as a 48-week, Phase 3, randomized, open-label, multicenter study comparing EFV+FTC+TDF (administered as the individual component drugs) versus CBV (lamivudine/zidovud...
Eligibility Criteria
Inclusion
- Participants must have met all inclusion criteria within 28 days prior to randomization unless specified otherwise including:
- Plasma HIV-1 RNA levels greater than 10,000 c/mL using Roche Amplicor HIV-1 Monitor Test Version 1.5 Standard
- Adequate renal function: Calculated creatinine clearance greater than or equal to 50 mL/min according to the Cockcroft-Gault Formula.
- Hepatic transaminases (aspartate aminotransferase \[AST\] and alanine aminotransferase \[ALT\]) 3 x upper limit of normal (ULN).
- Total bilirubin less than or equal to 1.5 mg/dL.
- Adequate hematologic function (absolute neutrophil count greater than or equal to 1,000/mm\^3; platelets greater than or equal to 50,000/mm\^3; hemoglobin greater than or equal to 8.0 g/dL).
- Serum amylase less than or equal to 1.5 x ULN.
- Serum phosphorus greater than or equal to 2.2 mg/dL.
- Willingness to use effective contraception by both males and females while on study treatment and for 30 days following study drug completion.
- Life expectancy greater than or equal to 1 year
- The ability to understand and sign written informed consent form obtained prior to initiation of study procedures.
Exclusion
- Participants were not eligible for entry to the study if any of the following were met:
- Prior treatment with any non-nucleoside reverse transcriptase inhibitor (NNRTI), nucleoside reverse transcriptase inhibitor (NRTI), or protease inhibitor (PI).
- A new AIDS-defining condition diagnosed (exception CD4 criteria) within 30 days of baseline.
- Receiving ongoing therapy with any of the following: nephrotoxic agents, probenecid, systemic chemotherapeutic agents, systemic corticosteroids, interleukin-2, drugs that interact with efavirenz. Administration of any of the above medications must be discontinued at least 30 days prior to baseline visit and for duration of study.
- Pregnant or lactating participants.
- Malignancy other than cutaneous Kaposi's sarcoma (KS) or basal cell carcinoma. Participants with biopsy-confirmed KS were eligible but must not have received any systemic therapy for KS within 30 days of baseline and not anticipated starting systemic therapy during the study.
- Prior history of renal or bone disease.
- Any other clinical condition prior to therapy that would make the participant unsuitable for the study or unable to comply with the dosing requirements in the opinion of the investigator.
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
517 Patients enrolled
Trial Details
Trial ID
NCT00112047
Start Date
July 1 2003
End Date
June 1 2009
Last Update
October 13 2010
Active Locations (5)
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1
AIDS Healthcare Foundation Research
Beverly Hills, California, United States, 90211
2
Capital Medical Associates, P.C.
Washington D.C., District of Columbia, United States, 20036
3
Orlando Immunology Center
Orlando, Florida, United States, 32804
4
NorthStar Medical Center
Chicago, Illinois, United States, 60657