A Study on the Safety and Effectiveness of Adefovir Dipivoxil in Combination With Anti-HIV Therapy (HAART) in HIV-Positive Patients
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Safety and Efficacy of Adefovir Dipivoxil as Intensification Therapy in Combination With Highly Active Antiretroviral Therapy (HAART) in HIV Infected Patients With HIV-1 RNA > 50 and <= 400 Copies/Ml
2 other identifiers
interventional
390
5 countries
49
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hiv-infections
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
December 1, 1999
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- You may be eligible for this study if you:
- Are HIV-positive.
- Have been on a stable HAART regimen consisting of at least 3 antiretroviral drugs for at least 16 weeks prior to study entry.
- Have a CD4 count of 50 cells/mm3 or more.
- Have a viral load greater than 50 and less than or equal to 400 copies/ml within 14 days prior to study entry.
- Have had at least 1 additional viral load in the past that was less than or equal to 400 copies/ml while on your current stable HAART regimen.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (49)
Pacific Oaks Research
Beverly Hills, California, 90211, United States
ViRx Inc
Palm Springs, California, 92262, United States
Ctr for AIDS Research / Education and Service (CARES)
Sacramento, California, 95814, United States
San Francisco Gen Hosp / UCSF AIDS Program
San Francisco, California, 94110, United States
Kaiser Foundation Hospital
San Francisco, California, 94118, United States
San Francisco VA Med Ctr
San Francisco, California, 94121, United States
Blick Med Associates
Stamford, Connecticut, 06901, United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007, United States
Dupont Circle Physicians Group
Washington D.C., District of Columbia, 200091104, United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037, United States
IDC Research Initiative
Altamonte Springs, Florida, 32701, United States
Community AIDS Resource Inc
Coral Gables, Florida, 33146, United States
TheraFirst Med Ctrs Inc
Fort Lauderdale, Florida, 33308, United States
Duval County Health Department
Jacksonville, Florida, 32206, United States
Health Positive
Safety Harbor, Florida, 34695, United States
Center for Quality Care
Tampa, Florida, 33609, United States
Georgia Research Associates
Atlanta, Georgia, 30342, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612, United States
Indiana Univ Infectious Disease Research Clinic
Indianapolis, Indiana, 46202, United States
Johns Hopkins Univ School of Medicine
Baltimore, Maryland, 21205, United States
Albany Med College
Albany, New York, 12208, United States
Bentley-Salick Med Practice
New York, New York, 10011, United States
St Luke Roosevelt Hosp
New York, New York, 10011, United States
James Jones MD
New York, New York, 10019, United States
Mount Sinai Med Ctr
New York, New York, 10029, United States
Wake Forest Univ School of Medicine
Winston-Salem, North Carolina, 27157, United States
Associates of Med and Mental Health
Tulsa, Oklahoma, 74114, United States
The Research and Education Group
Portland, Oregon, 97210, United States
Miriam Hosp
Providence, Rhode Island, 02906, United States
Roger Williams Med Ctr
Providence, Rhode Island, 02908, United States
Vanderbilt Univ School of Medicine
Nashville, Tennessee, 37212, United States
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 75235, United States
Univ of Texas Med Branch
Galveston, Texas, 77555, United States
Thomas Street Clinic
Houston, Texas, 77009, United States
Univ of Utah Med School / Clinical Trials Ctr
Salt Lake City, Utah, 84108, United States
Infectious Disease Physicians Inc
Annandale, Virginia, 22203, United States
N Touch Research Corp
Seattle, Washington, 98122, United States
St Paul's Hosp
Vancouver, British Columbia, Canada
Sunnybrook Health Science Centre
Toronto, Ontario, Canada
Centre hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, Canada
Hopital Edouard Herriot
Lyon, France
Hopital Sainte-Marguerite
Marseille, France
Klinikum Der Johann Wolfgang Goethe Universitat
Frankfurt, Germany
Universitatskrankenhaus Eppendorf
Hamburg, Germany
Klinikum der Ludwig-Maximilians-Universitaet
München, Germany
Chelsea and Westminster Hosp
London, United Kingdom
King's College Hospital
London, United Kingdom
Royal Free Hosp
London, United Kingdom
Senior Lecturer in GU Medicine
London, United Kingdom