A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Adefovir Dipivoxil When Added to Standard Antiretroviral Therapy for the Treatment of HIV-Infected Patients With CD4 Cell Counts >= 200/mm3
- Conditions
- HIV Infections
- Registration Number
- NCT00002161
- Lead Sponsor
- Gilead Sciences
- Brief Summary
To evaluate the anti-HIV activity, safety, and tolerance of adefovir dipivoxil ( bis-POM PMEA ) in combination with standard antiretroviral therapy for 48 weeks.
- Detailed Description
Patients are randomized to receive either adefovir dipivoxil or placebo daily for 24 weeks, after which all patients will receive open-label drug for an additional 24 weeks. Study drug is administered in combination with a current antiretroviral regimen for the entire 48 weeks. Patients are followed every 4 weeks during the first 24 weeks of study, then every 8 weeks during the last 24 weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
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 (27)
AIDS Research Consortium of Atlanta
🇺🇸Atlanta, Georgia, United States
East Bay AIDS Ctr
🇺🇸Berkeley, California, United States
Chicago Ctr for Clinical Research
🇺🇸Chicago, Illinois, United States
Northwestern Univ Med Ctr
🇺🇸Chicago, Illinois, United States
Harvard Univ / Massachusetts Gen Hosp
🇺🇸Boston, Massachusetts, United States
Institute for Clinical Research
🇺🇸Washington, District of Columbia, United States
Houston Clinical Research Network
🇺🇸Houston, Texas, United States
Kraus Med Partners
🇺🇸Los Angeles, California, United States
San Mateo County Med Ctr / San Mateo County AIDS Prog
🇺🇸San Mateo, California, United States
Pacific Oaks Research
🇺🇸Sherman Oaks, California, United States
Harbor UCLA Med Ctr
🇺🇸Torrance, California, United States
Univ of South Florida
🇺🇸St. Petersburg, Florida, United States
Univ of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
San Francisco Gen Hosp
🇺🇸San Francisco, California, United States
Santa Clara Valley Med Ctr
🇺🇸San Jose, California, United States
Carolinas Med Ctr
🇺🇸Charlotte, North Carolina, United States
Wayne State Univ / Univ Health Ctr
🇺🇸Detroit, Michigan, United States
The Research and Education Group
🇺🇸Portland, Oregon, United States
Saint Vincent's Med Ctr
🇺🇸New York, New York, United States
Albany Med College / Clinical Pharmacy Studies
🇺🇸Albany, New York, United States
Univ of Texas
🇺🇸Galveston, Texas, United States
Vanderbilt Univ Med Ctr
🇺🇸Nashville, Tennessee, United States
Univ of Wisconsin
🇺🇸Madison, Wisconsin, United States
Georgetown Univ Med Ctr
🇺🇸Washington, District of Columbia, United States
Tulane Univ / Tulane / LSU Clinical Trials Unit
🇺🇸New Orleans, Louisiana, United States
Dallas VA Med Ctr
🇺🇸Dallas, Texas, United States
Univ of Utah School of Medicine
🇺🇸Salt Lake City, Utah, United States