Tenofovir Disoproxil Fumarate (DF)/Emtricitabine/Efavirenz Versus Combivir/Efavirenz in Antiretroviral-Naive HIV-1 Infected Subjects
Information source: Gilead Sciences
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Viread (tenofovir disoproxil fumarate ) (Drug); Emtriva (emtricitabine) (Drug); Combivir (zidovudine + lamivudine) (Drug); Sustiva (efavirenz) (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Gilead Sciences Official(s) and/or principal investigator(s):
Andrew Cheng, MD, PhD, Study Director, Affiliation: Gilead Sciences
Summary
The purpose of this study is to assess two regimens in antiretroviral-naive subjects.
Clinical Details
Official title: Phase 3/Randomized/Open-Label Study of the Treatment of Antiretroviral-Naive HIV-1-Infected Subjects Comparing Tenofovir Disoproxil Fumarate and Emtricitabine in Combination With Efavirenz vs. Combivir (Lamivudine/Zidovudine) and Efavirenz
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Assess non-inferiority of Tenofovir DF/Emtricitabine/Efavirenz compared to Combivir/Efavirenz as determined by the proportion of patients with HIV RNA less than 400 c/mL at week 48 using the time to loss of virologic response (TLOVR) algorithm.
Secondary outcome: Evaluate safety and efficacy in 2 treatment regimens thru 144 weeks
Detailed description:
The purpose of this study is to assess two regimens in antiretroviral-naive subjects.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria: Subjects must meet all inclusion criteria within 28 days prior to
randomization unless specified otherwise:
- Plasma HIV-1 RNA levels greater than 10,000 copies/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 Cockcroft-Gault Formula.
- Hepatic transaminases (AST and ALT) less than or equal to 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/mm3; platelets greater than or equal to 50,000/mm3; 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 Criteria: Subjects are not eligible for study if any of the following are 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 subjects.
- Malignancy other than cutaneous Kaposi's sarcoma (KS) or basal cell carcinoma.
Subjects with biopsy confirmed KS are eligible but must not have received any systemic
therapy for KS within 30 days of baseline and not anticipate starting systemic therapy
during the study.
- Prior history of renal or bone disease.
- Any other clinical condition prior to therapy that would make the subject unsuitable
for the study or unable to comply with the dosing requirements in the opinion of the
investigator.
Locations and Contacts
AIDS Healthcare Foundation Research, Beverly Hills, California 90211, United States
Capital Medical Associates, P.C., Washington, District of Columbia 20036, United States
Orlando Immunology Center, Orlando, Florida 32804, United States
NorthStar Medical Center, Chicago, Illinois 60657, United States
Jemsek Clinic, Huntersville, North Carolina 28078, United States
Additional Information
Gilead Website Viread website Emtriva website Sustiva website Combivir website Study Results
Starting date: August 2003
Ending date: November 2006
Last updated: April 7, 2008
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