A Study on the Safety and Effectiveness of L-756423 Plus Indinavir in HIV-Positive Patients Who Have Previously Taken Indinavir
- Conditions
- HIV Infections
- Registration Number
- NCT00002452
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The purpose of this study is to see if L-756423, an anti-HIV drug, is safe to give with indinavir and if it works well at lowering the level of HIV in the blood (viral load).
- Detailed Description
All patients receive L-756423 plus indinavir plus two licensed nucleoside reverse transcriptase inhibitors (NRTIs), at least one to which the patient is naive. Patients remain on the drug regimen for 12 weeks (with possible extension to 16 weeks). Patients are evaluated with physical examinations and laboratory tests for blood and urine at Weeks 1, 2, 4, 6, 8, and 12 and two weeks post study. Plasma viral RNA is measured at Weeks 1, 2, 4, 6, 8, and 12. CD4 cell counts are measured at Weeks 2,4,8, and 12.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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 (8)
Hawaii AIDS Clinical Trial Unit
🇺🇸Honolulu, Hawaii, United States
Cornell Clinical Trials Unit - Chelsea Clinic
🇺🇸New York, New York, United States
Univ of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
AIDS Research Consortium of Atlanta
🇺🇸Atlanta, Georgia, United States
Georgetown Univ
🇺🇸Washington, District of Columbia, United States
Vanderbilt Univ Med Ctr
🇺🇸Nashville, Tennessee, United States
The CORE Ctr
🇺🇸Chicago, Illinois, United States
Pittsburgh Treatment Ctr / Univ of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States