Safety and Effectiveness of Adding PMPA Prodrug to an Anti-HIV Drug Combination to Treat HIV-Infected Patients
- Conditions
- HIV Infections
- Registration Number
- NCT00002415
- Lead Sponsor
- Gilead Sciences
- Brief Summary
The purpose of this study is to see if it is safe and effective to add PMPA Prodrug (a new anti-HIV drug) to an anti-HIV drug combination taken by patients who have taken anti-HIV drugs in the past. Genetic response will be studied.
- Detailed Description
Prior to study entry patients are stratified according to HIV-1 RNA level, CD4 cell count, and number of antiretroviral drugs. PMPA Prodrug or placebo is added to current antiretroviral regimens, and is administered in one of three dosing regimens. Patients randomized to receive placebo are eligible to receive open-label PMPA Prodrug for the remainder of the 48-week study period after at least 24 weeks post randomization.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 175
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 (24)
Harbor UCLA Med Ctr
🇺🇸Torrance, California, United States
Hershey Med Ctr
🇺🇸Hershey, Pennsylvania, United States
San Francisco Veterans Adm Med Cntr
🇺🇸San Francisco, California, United States
The Research and Education Group
🇺🇸Portland, Oregon, United States
East Bay AIDS Ctr
🇺🇸Berkeley, California, United States
McDowell Clinic
🇺🇸Phoenix, Arizona, United States
Univ of Colorado Health Sciences Ctr
🇺🇸Denver, Colorado, United States
Amelia Ct Clinic
🇺🇸Dallas, Texas, United States
Beth Israel Med Ctr
🇺🇸New York, New York, United States
Cornell Clinical Trials Unit - Chelsea Clinic
🇺🇸New York, New York, United States
CRI New England
🇺🇸Brookline, Massachusetts, United States
Univ of Minnesota
🇺🇸Minneapolis, Minnesota, United States
UCSD Treatment Ctr
🇺🇸San Diego, California, United States
Tower Infectious Disease Med Ctr
🇺🇸Los Angeles, California, United States
AIDS Research Consortium of Atlanta Inc
🇺🇸Atlanta, Georgia, United States
Grady Mem Hosp
🇺🇸Atlanta, Georgia, United States
Univ Hosps of Cleveland
🇺🇸Cleveland, Ohio, United States
Private Practice / Thacker and Thompson
🇺🇸Atlanta, Georgia, United States
Northstar Med Clinic
🇺🇸Chicago, Illinois, United States
Anderson Clinical Research
🇺🇸Pittsburgh, Pennsylvania, United States
Thomas Street Clinic
🇺🇸Houston, Texas, United States
Univ of Alabama at Birmingham / 1917 Rsch Cln
🇺🇸Birmingham, Alabama, United States
Hillsborough County Health Dept Special Care Ctr
🇺🇸Tampa, Florida, United States
Roger Williams Med Ctr
🇺🇸Providence, Rhode Island, United States