Safety and Effectiveness of Tenofovir Disoproxil Fumarate (Tenofovir DF) Plus Other Anti-HIV Drugs in HIV-Infected Patients
- Conditions
- HIV Infections
- Registration Number
- NCT00002450
- Lead Sponsor
- Gilead Sciences
- 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.
- Detailed Description
Patients are randomized 2:1 to add tenofovir DF once daily or placebo to their existing antiretroviral regimen in a blinded manner. Patients are stratified according to HIV-1 RNA level, CD4 cell count, and number of antiretroviral drugs taken prior to study entry. Patients and physicians are strongly discouraged from making changes in their antiviral therapies for at least 24 weeks post-randomization. After Week 24, changes in background antiretroviral therapy are permitted. At 24 weeks post-randomization, patients randomized to receive placebo are crossed over to receive open-label tenofovir DF once daily for the remainder of the 48-week study. While on study drug, patients are monitored for safety using periodic physical examinations and serial laboratory tests. Additionally, changes in plasma HIV RNA levels and CD4 cell counts are monitored to assess antiviral efficacy. At the end of the 48-week study period, patients are rolled over into extended dosing until tenofovir DF is commercially available or Gilead Sciences terminates the study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 600
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 (61)
Tower Infectious Diseases / Med Associates Inc
🇺🇸Los Angeles, California, United States
Remington Davis Inc
🇺🇸Columbus, Ohio, United States
Thomas Street Clinic
🇺🇸Houston, Texas, United States
Univ of Texas / Thomas Street Clinic
🇺🇸Houston, Texas, United States
AIDS Research Consortium of Atlanta Inc
🇺🇸Atlanta, Georgia, United States
Univ of Rochester Medical Center
🇺🇸Rochester, New York, United States
Howard Grossman
🇺🇸New York, New York, United States
St Vincent's Hosp
🇺🇸New York, New York, United States
Brookdale Univ Hosp and Med Ctr
🇺🇸Brooklyn, New York, United States
Nicholas Bellos
🇺🇸Dallas, Texas, United States
Pennsylvania State College of Medicine
🇺🇸Hershey, Pennsylvania, United States
Miriam Hosp / Brown Univ
🇺🇸Providence, Rhode Island, United States
Hampton Roads Med Specialists
🇺🇸Hampton, Virginia, United States
Infections Ltd / Physicians Med Ctr
🇺🇸Tacoma, Washington, United States
Regions Hosp / HIV/AIDS Program
🇺🇸St. Paul, Minnesota, United States
Univ of Colorado / Health Science Ctr
🇺🇸Denver, Colorado, United States
UCSD Med Ctr - Owen Clinic
🇺🇸San Diego, California, United States
San Francisco VA Med Ctr
🇺🇸San Francisco, California, United States
Univ of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Cedars Sinai Med Ctr
🇺🇸Los Angeles, California, United States
Robert Scott MD
🇺🇸Oakland, California, United States
St Mary's Med Ctr
🇺🇸Long Beach, California, United States
Kaiser Permanente LAMC
🇺🇸Los Angeles, California, United States
Kaiser Foundation Hospital
🇺🇸San Francisco, California, United States
Bronx Lebanon Hosp Ctr
🇺🇸Bronx, New York, United States
AIDS Healthcare Foundation-Research Center
🇺🇸Los Angeles, California, United States
Albany Med College
🇺🇸Albany, New York, United States
Harbor UCLA Med Ctr / Research and Educational Institute
🇺🇸Torrance, California, United States
Dallas Veterans Administration Med Ctr
🇺🇸Dallas, Texas, United States
Univ of NM
🇺🇸Albuquerque, New Mexico, United States
Ponce de Leon Med Ctr
🇺🇸Atlanta, Georgia, United States
Ian Baird
🇺🇸Columbus, Ohio, United States
Columbia Univ
🇺🇸New York, New York, United States
Oklahoma Univ Health Science Ctr
🇺🇸Oklahoma City, Oklahoma, United States
Hillsborough County Health Dept
🇺🇸Tampa, Florida, United States
Ponce Univ Hosp
🇵🇷Ponce, Puerto Rico
Ocean View Internal Medicine
🇺🇸Long Beach, California, United States
LAC / USC Med Ctr / Infectious Diseases
🇺🇸Los Angeles, California, United States
Pacific Horizons Med Group
🇺🇸San Francisco, California, United States
Physicans Home Service
🇺🇸Washington, District of Columbia, United States
Northstar Med Clinic
🇺🇸Chicago, Illinois, United States
Bendel Med Research
🇺🇸Lafayette, Louisiana, United States
Nalle Clinic / Clinical Research Dept
🇺🇸Charlotte, North Carolina, United States
Univ TX San Antonio Health Science Ctr
🇺🇸San Antonio, Texas, United States
Infectious Diseases Physicians Inc
🇺🇸Annandale, Virginia, United States
Infections Ltd PS
🇺🇸Puyallup, Washington, United States
Steinhart Medical Associates
🇺🇸Miami, Florida, United States
Univ of Miami School of Medicine
🇺🇸Miami, Florida, United States
Phoenix Body Positive
🇺🇸Phoenix, Arizona, United States
Harper Hosp
🇺🇸Detroit, Michigan, United States
Massachusetts Gen Hosp
🇺🇸Boston, Massachusetts, United States
Therafirst Med Ctr
🇺🇸Fort Lauderdale, Florida, United States
Yale-New Haven Hospital
🇺🇸New Haven, Connecticut, United States
Clinical Research Puerto Rico Inc
🇵🇷San Juan, Puerto Rico
San Juan AIDS Program
🇵🇷Santurce, Puerto Rico
George Washington Univ Med Ctr
🇺🇸Washington, District of Columbia, United States
ARTCTC
🇺🇸Fort Pierce, Florida, United States
Treasure Coast Infectious Disease Consultants
🇺🇸Vero Beach, Florida, United States
Dr Joel Gallant
🇺🇸Baltimore, Maryland, United States
New England Med Ctr
🇺🇸Boston, Massachusetts, United States
Yale New Haven Hosp / Nathan Smith Clinic
🇺🇸New Haven, Connecticut, United States