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)
Phoenix Body Positive
🇺🇸Phoenix, Arizona, United States
Pacific Oaks Med Group
🇺🇸Beverly Hills, California, United States
First Choice Medical
🇺🇸Palm Springs, California, United States
Apogee Med Group
🇺🇸San Diego, California, United States
Saint Francis Mem Hosp / HIV Care Unit
🇺🇸San Francisco, California, United States
Kaiser Foundation Hospital
🇺🇸San Francisco, California, United States
Harbor - UCLA Med Ctr
🇺🇸Torrance, California, United States
Univ of Colorado Health Sciences Ctr
🇺🇸Denver, Colorado, United States
Bach and Godofsky
🇺🇸Bradenton, Florida, United States
Clin Research of West Florida
🇺🇸Clearwater, Florida, United States
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