Safety and Effectiveness of Tenofovir Disoproxil Fumarate (Tenofovir DF) Plus Other Anti-HIV Drugs in HIV-Infected Patients
A Phase III, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study of the Safety and Efficacy of Tenofovir Disoproxil Fumarate in Combination With Other Antiretroviral Agents for the Treatment of HIV-1 Infected Patients
2 other identifiers
interventional
600
2 countries
61
Brief Summary
The purpose of this study is to see if giving tenofovir DF plus a combination of other anti-HIV drugs is safe and effective.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 hiv-infections
61 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2000
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
July 1, 2000
January 17, 2000
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients may be eligible for this study if they:
- Are HIV-positive.
- Have been on stable anti-HIV therapy for at least 8 weeks with no more than 4 anti-HIV drugs at the time of study entry.
- Have a viral load (level of HIV in the blood) between 400 and 10,000 copies/ml.
- Have good kidney function.
- Are 18 to 65 years old.
- Agree to use a barrier method of birth control (such as condoms) during the study and for 30 days after.
You may not qualify if:
- Patients will not be eligible for this study if they:
- Have a new AIDS-related illness diagnosed within 30 days of study entry.
- Have any other serious medical conditions, including kidney or bone disease, an active infection requiring antibiotics, or cancer (other than Kaposi's sarcoma or certain skin cancers).
- Have received a vaccine within 30 days of study entry.
- Are unable to take medications by mouth.
- Have ever taken tenofovir or adefovir dipivoxil.
- Have taken certain medications within 30 days of study entry, such as chemotherapy, corticosteroids, medications that affect the kidneys, treatment for Kaposi's sarcoma, or certain experimental drugs.
- Abuse alcohol or drugs.
- Are pregnant or breast-feeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (61)
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Phoenix Body Positive
Phoenix, Arizona, 85016, United States
Ocean View Internal Medicine
Long Beach, California, 90803, United States
St Mary's Med Ctr
Long Beach, California, 90813, United States
AIDS Healthcare Foundation-Research Center
Los Angeles, California, 90027, United States
Kaiser Permanente LAMC
Los Angeles, California, 90027, United States
LAC / USC Med Ctr / Infectious Diseases
Los Angeles, California, 90033, United States
Cedars Sinai Med Ctr
Los Angeles, California, 90048, United States
Tower Infectious Diseases / Med Associates Inc
Los Angeles, California, 90048, United States
Robert Scott MD
Oakland, California, 94609, United States
UCSD Med Ctr - Owen Clinic
San Diego, California, 921038681, United States
Pacific Horizons Med Group
San Francisco, California, 94115, United States
Kaiser Foundation Hospital
San Francisco, California, 94118, United States
San Francisco VA Med Ctr
San Francisco, California, 94121, United States
Harbor UCLA Med Ctr / Research and Educational Institute
Torrance, California, 90502, United States
Univ of Colorado / Health Science Ctr
Denver, Colorado, 80262, United States
Yale New Haven Hosp / Nathan Smith Clinic
New Haven, Connecticut, 06504, United States
Yale-New Haven Hospital
New Haven, Connecticut, 06504, United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037, United States
Physicans Home Service
Washington D.C., District of Columbia, 20037, United States
Therafirst Med Ctr
Fort Lauderdale, Florida, 33308, United States
ARTCTC
Ft. Pierce, Florida, 34950, United States
Steinhart Medical Associates
Miami, Florida, 33133, United States
Univ of Miami School of Medicine
Miami, Florida, 33136, United States
Hillsborough County Health Dept
Tampa, Florida, 33602, United States
Treasure Coast Infectious Disease Consultants
Vero Beach, Florida, 32960, United States
AIDS Research Consortium of Atlanta Inc
Atlanta, Georgia, 30308, United States
Ponce de Leon Med Ctr
Atlanta, Georgia, 30308, United States
Northstar Med Clinic
Chicago, Illinois, 60657, United States
Bendel Med Research
Lafayette, Louisiana, 70503, United States
Dr Joel Gallant
Baltimore, Maryland, 21205, United States
New England Med Ctr
Boston, Massachusetts, 02111, United States
Massachusetts Gen Hosp
Boston, Massachusetts, 02114, United States
Harper Hosp
Detroit, Michigan, 48201, United States
Regions Hosp / HIV/AIDS Program
Saint Paul, Minnesota, 55101, United States
Univ of NM
Albuquerque, New Mexico, 87131, United States
Albany Med College
Albany, New York, 12208, United States
Brookdale Univ Hosp and Med Ctr
Brooklyn, New York, 112123198, United States
Howard Grossman
New York, New York, 10011, United States
St Vincent's Hosp
New York, New York, 10011, United States
Columbia Univ
New York, New York, 10032, United States
Univ of Rochester Medical Center
Rochester, New York, 14642, United States
Bronx Lebanon Hosp Ctr
The Bronx, New York, 10457, United States
Nalle Clinic / Clinical Research Dept
Charlotte, North Carolina, 28207, United States
Ian Baird
Columbus, Ohio, 43214, United States
Remington Davis Inc
Columbus, Ohio, 43215, United States
Oklahoma Univ Health Science Ctr
Oklahoma City, Oklahoma, 73104, United States
Pennsylvania State College of Medicine
Hershey, Pennsylvania, 17033, United States
Miriam Hosp / Brown Univ
Providence, Rhode Island, 02906, United States
Dallas Veterans Administration Med Ctr
Dallas, Texas, 75216, United States
Nicholas Bellos
Dallas, Texas, 75246, United States
Thomas Street Clinic
Houston, Texas, 77009, United States
Univ of Texas / Thomas Street Clinic
Houston, Texas, 77030, United States
Univ TX San Antonio Health Science Ctr
San Antonio, Texas, 78284, United States
Infectious Diseases Physicians Inc
Annandale, Virginia, 22003, United States
Hampton Roads Med Specialists
Hampton, Virginia, 23666, United States
Infections Ltd PS
Puyallup, Washington, 98371, United States
Infections Ltd / Physicians Med Ctr
Tacoma, Washington, 98405, United States
Ponce Univ Hosp
Ponce, 00731, Puerto Rico
Clinical Research Puerto Rico Inc
San Juan, 009091711, Puerto Rico
San Juan AIDS Program
Santurce, 00908, Puerto Rico