A Study on the Safety and Effectiveness of Adefovir Dipivoxil in Combination With Anti-HIV Therapy (HAART) in HIV-Positive Patients
- Conditions
- HIV Infections
- Registration Number
- NCT00002426
- Lead Sponsor
- Gilead Sciences
- Brief Summary
The purpose of this study is to see if it is safe and effective to give an experimental anti-HIV drug, adefovir dipivoxil (ADV), in combination with other anti-HIV drugs (HAART) to patients who have a viral load (level of HIV in the blood) between 50 and 400 copies/ml.
- Detailed Description
Patients are randomized to 1 of 2 arms in a 2:1 ratio. Approximately 260 patients receive ADV and approximately 130 patients receive placebo. Patients receive ADV or placebo in addition to L-carnitine and their current stable HAART regimen. Each patient receives blinded study medication for 48 weeks and is evaluated at Weeks 16, 24, and 48. Patients who reach the primary endpoint of virologic failure prior to Week 48 may continue blinded study medication or receive open-label ADV at the investigator's discretion. In both cases, patients continue their study visits as per the original visit schedule. Virologic failure is defined as 2 consecutive HIV-1 RNA measurements, after baseline, above 400 copies/ml (measured by the Roche Amplicor HIV-1 Monitor UltraSensitive assay) drawn at least 14 days apart. All patients who complete study visits without treatment-limiting ADV toxicity may continue open-label ADV in the Maintenance Phase at the discretion of the principal investigator.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 390
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 (49)
Pacific Oaks Research
🇺🇸Beverly Hills, California, United States
ViRx Inc
🇺🇸Palm Springs, California, United States
Ctr for AIDS Research / Education and Service (CARES)
🇺🇸Sacramento, California, United States
San Francisco Gen Hosp / UCSF AIDS Program
🇺🇸San Francisco, California, United States
Kaiser Foundation Hospital
🇺🇸San Francisco, California, United States
San Francisco VA Med Ctr
🇺🇸San Francisco, California, United States
Blick Med Associates
🇺🇸Stamford, Connecticut, United States
Georgetown Univ Med Ctr
🇺🇸Washington, District of Columbia, United States
Dupont Circle Physicians Group
🇺🇸Washington, District of Columbia, United States
George Washington Univ Med Ctr
🇺🇸Washington, District of Columbia, United States
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