Indinavir Plus Efavirenz Plus Adefovir Dipivoxil in HIV-Infected Patients Who Have Not Had Success With Nelfinavir
- Conditions
- HIV Infections
- Registration Number
- NCT00002220
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The purpose of this study is to compare the effectiveness of giving indinavir plus efavirenz plus adefovir dipivoxil to patients who have failed treatment with nelfinavir and patients who have never taken a protease inhibitor (PI). Effectiveness is measured by the number of patients who have a viral load (level of HIV in the blood) below 400 copies/ml after 48 weeks of treatment.
- Detailed Description
In this open-label, nonrandomized study, 120 HIV-infected patients are stratified into two groups: failed nelfinavir vs protease inhibitor-naive. All patients receive indinavir plus efavirenz plus adefovir dipivoxil plus and L-carnitine, orally. Plasma vRNA is measured every 4 weeks until Week 16, then every 8 weeks for the remainder of the 48-week study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
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 (11)
Hawaii AIDS Clinical Trial Unit
🇺🇸Honolulu, Hawaii, United States
LAC / USC Med Ctr / Infectious Diseases
🇺🇸Los Angeles, California, United States
Med Ctr of Delaware
🇺🇸Wilmington, Delaware, United States
Rush Presbyterian Saint Lukes Med Ctr
🇺🇸Chicago, Illinois, United States
Yale Univ / AIDS Clinical Trials Unit
🇺🇸New Haven, Connecticut, United States
Johns Hopkins Hosp
🇺🇸Baltimore, Maryland, United States
Massachusetts Gen Hosp
🇺🇸Boston, Massachusetts, United States
Columbia Presbyterian Hosp
🇺🇸New York, New York, United States
AIDS TMT Unit / Univ Hosp
🇺🇸Stonybrook, New York, United States
Oaklawn Physicians Group
🇺🇸Dallas, Texas, United States
Vanderbilt Clinic
🇺🇸Nashville, Tennessee, United States