The Safety and Effectiveness of Adefovir Dipivoxil Plus Indinavir Combined With Zidovudine or Lamivudine or Stavudine in HIV-Infected Patients Who Have Not Taken Anti-HIV Drugs
- Conditions
- HIV Infections
- Registration Number
- NCT00002379
- Lead Sponsor
- Gilead Sciences
- Brief Summary
To evaluate the safety and tolerance of adefovir dipivoxil and indinavir administered orally in combination with zidovudine, lamivudine, or stavudine in HIV-infected patients with CD4 cell counts \>= 100 cells/mm3 and an HIV-1 RNA baseline copy number \>= 5000 copies/ml. To determine the proportion of patients whose plasma HIV-1 RNA level falls below the level of detection (500 copies/ml) by 20 weeks of study therapy and the average reduction in HIV-1 RNA from baseline through study week 20. To evaluate the durability of the antiviral response through 48 weeks of study in patients who continue on study therapy after week 24.
- Detailed Description
This protocol is a stratified, randomized, open-label study of the safety and efficacy of adefovir dipivoxil with indinavir as quadruple therapy in combination with zidovudine and lamivudine, or as triple combination administered with either zidovudine or lamivudine or stavudine for 48 weeks in the treatment of HIV-infected patients with CD4 cell counts \>= 100/mm3 and an HIV-1 RNA baseline copy number \>= 5000 copies/ml. Patients will be randomized to adefovir dipivoxil, indinavir, zidovudine, and lamivudine or adefovir dipivoxil, indinavir, and a nucleoside inhibitor (randomly assigned to receive zidovudine, lamivudine, or stavudine) or to indinavir, zidovudine, and lamivudine. Additionally, a daily dose of L-carnitine will be administered to all patients randomized to an arm containing adefovir dipivoxil.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (15)
Phoenix Body Positive
🇺🇸Phoenix, Arizona, United States
Saint Vincent's AIDS Ctr
🇺🇸New York, New York, United States
George Washington Med Ctr
🇺🇸Washington, District of Columbia, United States
Community Research Initiative
🇺🇸Brookline, Massachusetts, United States
Hosp Regional de Ponce - Area Vieja
🇵🇷Ponce, Puerto Rico
Swedish Med Ctr
🇺🇸Seattle, Washington, United States
AIDS Healthcare Foundation Labs
🇺🇸Los Angeles, California, United States
Johns Hopkins Univ School of Medicine
🇺🇸Baltimore, Maryland, United States
Hershey Med Ctr / Dept of Hematology
🇺🇸Hershey, Pennsylvania, United States
Univ of Texas Southwestern Med Ctr of Dallas
🇺🇸Dallas, Texas, United States
Blick Med Associates
🇺🇸Greenwich, Connecticut, United States
Davies Med Ctr
🇺🇸San Francisco, California, United States
Community Research Initiative on AIDS
🇺🇸New York, New York, United States
Cook County Gen Hosp / Division of Infect Diseases
🇺🇸Chicago, Illinois, United States
Mem Hosp of Rhode Island
🇺🇸Pawtucket, Rhode Island, United States