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)
Health Positive
🇺🇸Safety Harbor, Florida, United States
Rush Presbyterian - Saint Luke's Med Ctr
🇺🇸Chicago, Illinois, United States
Thomas Street Clinic
🇺🇸Houston, Texas, United States
N Touch Research Corp
🇺🇸Seattle, Washington, United States
George Washington Univ Med Ctr
🇺🇸Washington, District of Columbia, United States
Vanderbilt Univ School of Medicine
🇺🇸Nashville, Tennessee, United States
Centre hospitalier de l'Universite de Montreal (CHUM)
🇨🇦Montreal, Quebec, Canada
St Paul's Hosp
🇨🇦Vancouver, British Columbia, Canada
Mount Sinai Med Ctr
🇺🇸New York, New York, United States
Hopital Sainte-Marguerite
🇫🇷Marseille, France
Johns Hopkins Univ School of Medicine
🇺🇸Baltimore, Maryland, United States
Bentley-Salick Med Practice
🇺🇸New York, New York, United States
St Luke Roosevelt Hosp
🇺🇸New York, New York, United States
Georgetown Univ Med Ctr
🇺🇸Washington, District of Columbia, United States
Community AIDS Resource Inc
🇺🇸Coral Gables, Florida, United States
Blick Med Associates
🇺🇸Stamford, Connecticut, United States
San Francisco Gen Hosp / UCSF AIDS Program
🇺🇸San Francisco, California, United States
Dupont Circle Physicians Group
🇺🇸Washington, District of Columbia, United States
TheraFirst Med Ctrs Inc
🇺🇸Fort Lauderdale, Florida, United States
Georgia Research Associates
🇺🇸Atlanta, Georgia, United States
James Jones MD
🇺🇸New York, New York, United States
Wake Forest Univ School of Medicine
🇺🇸Winston Salem, North Carolina, United States
Miriam Hosp
🇺🇸Providence, Rhode Island, United States
Associates of Med and Mental Health
🇺🇸Tulsa, Oklahoma, United States
Univ of Texas Southwestern Med Ctr of Dallas
🇺🇸Dallas, Texas, United States
Infectious Disease Physicians Inc
🇺🇸Annandale, Virginia, United States
Roger Williams Med Ctr
🇺🇸Providence, Rhode Island, United States
King's College Hospital
🇬🇧London, United Kingdom
Klinikum der Ludwig-Maximilians-Universitaet
🇩🇪Muenchen, Germany
Sunnybrook Health Science Centre
🇨🇦Toronto, Ontario, Canada
Hopital Edouard Herriot
🇫🇷Lyon Cedex 03, France
Universitatskrankenhaus Eppendorf
🇩🇪Hamburg, Germany
Klinikum Der Johann Wolfgang Goethe Universitat
🇩🇪Frankfurt, Germany
Chelsea and Westminster Hosp
🇬🇧London, United Kingdom
Senior Lecturer in GU Medicine
🇬🇧London, United Kingdom
Center for Quality Care
🇺🇸Tampa, Florida, United States
ViRx Inc
🇺🇸Palm Springs, California, United States
Duval County Health Department
🇺🇸Jacksonville, Florida, United States
IDC Research Initiative
🇺🇸Altamonte Springs, Florida, United States
San Francisco VA Med Ctr
🇺🇸San Francisco, California, United States
Pacific Oaks Research
🇺🇸Beverly Hills, California, United States
Ctr for AIDS Research / Education and Service (CARES)
🇺🇸Sacramento, California, United States
Kaiser Foundation Hospital
🇺🇸San Francisco, California, United States
Albany Med College
🇺🇸Albany, New York, United States
Univ of Utah Med School / Clinical Trials Ctr
🇺🇸Salt Lake City, Utah, United States
The Research and Education Group
🇺🇸Portland, Oregon, United States
Univ of Texas Med Branch
🇺🇸Galveston, Texas, United States
Royal Free Hosp
🇬🇧London, United Kingdom
Indiana Univ Infectious Disease Research Clinic
🇺🇸Indianapolis, Indiana, United States