Combination Treatment Using Capravirine (AG1549), Nelfinavir, and Two Nucleoside Reverse Transcriptase Inhibitors in HIV Patients Who Failed Initial Combination Therapy
- Conditions
- HIV Infections
- Registration Number
- NCT00004985
- Lead Sponsor
- Agouron Pharmaceuticals
- Brief Summary
The purpose of this study is to look at the effectiveness of an anti-HIV drug combination that adds capravirine in patients who have failed their first drug combination treatment.
- Detailed Description
\[Note: As of 2/28/2001, due to toxicity studies and concern for safety, changes in the methodology were implemented and patients need to sign new informed consents. The study is unblinded. Group 1 receives AG1549; Group 2 receives an AG1549 placebo. Patients who are taking capravirine and who currently have viral loads below 400 copies/ml may continue to take capravirine at 1400 mg twice daily. Capravirine will be discontinued in patients with viral loads greater than 400 copies/ml at their last visit and they will be switched to new therapies or continue with their background therapies as deemed appropriate by the investigators.\] Both groups also receive nelfinavir mesylate and 2 NRTIs. All patients receive the same dose of nelfinavir mesylate. The NRTIs are selected at the investigator's discretion provided the patient has not previously received the chosen NRTIs. Patients have regular physical examinations. Blood samples are collected regularly and at 1 month post-treatment to determine plasma HIV RNA, pharmacokinetics, and CD4 and CD8 counts. Patients who complete 24 weeks of treatment will have the option to continue treatment for an additional 24 weeks or end participation.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
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 (34)
Harbor - UCLA Med Ctr
🇺🇸Torrance, California, United States
Bach and Godofsky
🇺🇸Bradenton, Florida, United States
Clin Research of West Florida
🇺🇸Clearwater, Florida, United States
Community Health Care
🇺🇸Fort Lauderdale, Florida, United States
Braude Mermin Spivey MD PC
🇺🇸Atlanta, Georgia, United States
AIDS Research Consortium of Atlanta
🇺🇸Atlanta, Georgia, United States
Massachusetts Gen Hosp
🇺🇸Boston, Massachusetts, United States
Fenway Community Health Ctr
🇺🇸Boston, Massachusetts, United States
North Shore Univ Hosp
🇺🇸Manhasset, New York, United States
Apogee Med Group
🇺🇸San Diego, California, United States
South Shore Hosp
🇺🇸Miami, Florida, United States
Hillsborough County Health Dept
🇺🇸Tampa, Florida, United States
Pacific Oaks Med Group
🇺🇸Beverly Hills, California, United States
Immunity Care and Research Inc
🇺🇸Miami Beach, Florida, United States
Therafirst Med Ctr
🇺🇸Fort Lauderdale, Florida, United States
Jersey Shore Med Ctr
🇺🇸Neptune, New Jersey, United States
Treasure Coast Infectious Disease Consultants
🇺🇸Vero Beach, Florida, United States
Polk County Health Dept
🇺🇸Winter Haven, Florida, United States
Infectious Disease Assoc of Central Jersey
🇺🇸Somerville, New Jersey, United States
Univ TX Galveston Med Branch
🇺🇸Galveston, Texas, United States
Infectious Disease Physicians Inc
🇺🇸Annandale, Virginia, United States
Liberty Medical
🇺🇸New York, New York, United States
Clinical Research Puerto Rico Inc
🇵🇷San Juan, Puerto Rico
Phoenix Body Positive
🇺🇸Phoenix, Arizona, United States
Saint Francis Mem Hosp / HIV Care Unit
🇺🇸San Francisco, California, United States
Kaiser Foundation Hospital
🇺🇸San Francisco, California, United States
Univ of Colorado Health Sciences Ctr
🇺🇸Denver, Colorado, United States
Infectious Diseases Associates
🇺🇸Sarasota, Florida, United States
Orange County Health Dept
🇺🇸Orlando, Florida, United States
First Choice Medical
🇺🇸Palm Springs, California, United States
Mount Sinai Med Ctr
🇺🇸New York, New York, United States
Central Texas Clinical Research
🇺🇸Austin, Texas, United States
VAMC New Jersey Healthcare System
🇺🇸East Orange, New Jersey, United States
Biomedical Research Alliance of New York
🇺🇸Jamaica, New York, United States