Effectiveness of a New Anti-HIV Drug (AG1549) Plus Viracept (Nelfinavir) Plus Combivir (Zidovudine/Lamivudine) in HIV-Infected Patients
- Conditions
- HIV Infections
- Registration Number
- NCT00004999
- Lead Sponsor
- Agouron Pharmaceuticals
- Brief Summary
The purpose of this study is to look at the effectiveness of giving a new anti-HIV drug (AG1549) plus Viracept (nelfinavir) plus Combivir (a tablet containing zidovudine plus lamivudine) to HIV-infected patients who are not taking anti-HIV drugs.
- Detailed Description
\[Note: As of 2/28/2001, due to toxicity studies and concerns for safety, sites were notified that they need to discontinue patients from the capravirine/placebo arms and continue patients with their background therapies or switch patients to new therapies, as deemed appropriate by the investigators.\] Patients are randomized to receive Viracept plus Combivir plus either AG1549 or placebo. Patients remain on their assigned therapy for 48 weeks with one post-therapy follow-up visit. Blood samples are taken regularly to quantify plasma HIV-1 RNA, CD4 and CD8 counts, and peripheral blood mononuclear cells (PBMC). Physical exams, safety assessments, and other tests are also done throughout the study. A blood sample is taken at baseline (pre-dose) for a pharmacokinetics assessment. On Day 8 and at the end of Weeks 4, 8, 16, 24, 36, and 48, pharmacokinetic sampling is done prior to dosing and between 2 to 4 hours post-dose.
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 350
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 (53)
Univ of Southern California
🇺🇸Los Angeles, California, United States
Harbor - UCLA Med Ctr
🇺🇸Torrance, California, United States
Community Health Care
🇺🇸Fort Lauderdale, Florida, United States
Sunnybrook Health Science Centre
🇨🇦Toronto, Ontario, Canada
Univ of Miami School of Medicine
🇺🇸Miami, Florida, United States
South Shore Hosp
🇺🇸Miami, Florida, United States
Highland Gen Hosp / San Francisco Gen Hosp
🇺🇸Oakland, California, United States
Arizona Clinical Research Ctr Inc
🇺🇸Tucson, Arizona, United States
Univ of Florida
🇺🇸Jacksonville, Florida, United States
Paul Alessi
🇺🇸Cherry Hill, New Jersey, United States
St Mary's Hosp Family Treatment Ctr
🇺🇸Hoboken, New Jersey, United States
Joseph C Gathe
🇺🇸Houston, Texas, United States
Julio Arroyo
🇺🇸West Columbia, South Carolina, United States
Bentley-Salick Medical Practice PC
🇺🇸New York, New York, United States
Fenway Community Health Ctr
🇺🇸Boston, Massachusetts, United States
Univ of Med & Dentistry of New Jersey
🇺🇸Newark, New Jersey, United States
Univ TX Galveston Med Branch
🇺🇸Galveston, Texas, United States
Univ of Cincinnati / Holmes Hosp
🇺🇸Cincinnati, Ohio, United States
University of Louisville / ID Division
🇺🇸Louisville, Kentucky, United States
Polk County Health Dept
🇺🇸Winter Haven, Florida, United States
Northwestern Univ Med Ctr
🇺🇸Chicago, Illinois, United States
Immunity Care and Research Inc
🇩🇴Santo Domingo, Dominican Republic
Clinical Research Puerto Rico Inc
🇵🇷San Juan, Puerto Rico
Univ of Kansas School of Medicine
🇺🇸Wichita, Kansas, United States
Hawthorne Med Associates / PAACA
🇺🇸New Bedford, Massachusetts, United States
Southwest Infectious Diseases Associates
🇺🇸Dallas, Texas, United States
VAMC New Jersey Healthcare System
🇺🇸East Orange, New Jersey, United States
Med Univ of South Carolina
🇺🇸Charleston, South Carolina, United States
Univ of Rochester Med Ctr
🇺🇸Rochester, New York, United States
Montreal Chest Institute
🇨🇦Montreal, Quebec, Canada
ViRx Inc
🇺🇸Palm Springs, California, United States
Research & Treatment at the California Pacific Med Ctr
🇺🇸San Francisco, California, United States
IDC Research Initiative
🇺🇸Altamonte Springs, Florida, United States
Bach and Godofsky
🇺🇸Bradenton, Florida, United States
Sky Blue
🇺🇸Boise, Idaho, United States
Infectious Disease Research Institute
🇺🇸Tampa, Florida, United States
Infectious Diseases Associates
🇺🇸Sarasota, Florida, United States
Larry Bush
🇺🇸Palm Springs, Florida, United States
Specialty Med Care Ctrs of South Florida Inc
🇺🇸Miami, Florida, United States
The CORE Ctr
🇺🇸Chicago, Illinois, United States
Indiana Univ Infectious Disease Research Clinic
🇺🇸Indianapolis, Indiana, United States
HIV Outpatient Clinics / LA State Univ Med Ctr
🇺🇸New Orleans, Louisiana, United States
Kansas City AIDS Research Consortium
🇺🇸Kansas City, Missouri, United States
Thomas Street Clinic
🇺🇸Houston, Texas, United States
Hampton Roads Med Specialists
🇺🇸Hampton, Virginia, United States
QEII Health Science Centre
🇨🇦Halifax, Nova Scotia, Canada
Univ of Puerto Rico School of Med
🇵🇷Rio Piedras, Puerto Rico
Univ of Iowa
🇺🇸Iowa City, Iowa, United States
Orange County Health Dept
🇺🇸Orlando, Florida, United States
Treasure Coast Infectious Disease Consultants
🇺🇸Vero Beach, Florida, United States
Wisconsin AIDS Research Consortium
🇺🇸Milwaukee, Wisconsin, United States
Univ of Nebraska Medical Ctr
🇺🇸Omaha, Nebraska, United States
Canadian HIV Trials Network
🇨🇦Vancouver, British Columbia, Canada