A Comparison of Two Dose Levels of Indinavir Combined With Two Nucleoside Analogue Reverse Transcriptase Inhibitors (NRTIs) in HIV-Infected Patients
- Conditions
- HIV Infections
- Registration Number
- NCT00002406
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The purpose of this study is to determine if two dose levels of indinavir combined with two nucleoside analogue reverse transcriptase inhibitors (NRTIs) have the same effect on plasma viral load (level of HIV in the blood).
- Detailed Description
In this open-label study 350 seropositive HIV-1 men and women are first stratified according to baseline plasma viral RNA (less than 400 copies/mL vs negative plasma viral RNA result) then randomized into one of two arms:
Arm 1: Indinavir (800 mg, q8h) plus two pre-existing NRTIs. Arm 2: Indinavir (1,200 mg, q12h) plus two pre-existing NRTIs. Plasma viral RNA will be measured every 4 weeks for the duration of the 24-week study.
Recruitment & Eligibility
- Status
- COMPLETED
- 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 (28)
1917 Research Clinic
🇺🇸Birmingham, Alabama, United States
Kaiser Permanente / Infectious Disease
🇺🇸Los Angeles, California, United States
Tower ID Med Associates
🇺🇸Los Angeles, California, United States
Ctr for AIDS Research / Education and Service (CARES)
🇺🇸Sacramento, California, United States
San Francisco Gen Hosp / UCSF AIDS Program
🇺🇸San Francisco, California, United States
HIV Clinical Research
🇺🇸Fort Lauderdale, Florida, United States
Univ of Miami School of Medicine
🇺🇸Miami, Florida, United States
AIDS Research Consortium of Atlanta
🇺🇸Atlanta, Georgia, United States
Ponce de Leon Ctr
🇺🇸Atlanta, Georgia, United States
Northwestern Univ Med School
🇺🇸Chicago, Illinois, United States
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