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)
Anderson Clinical Research
🇺🇸Pittsburgh, Pennsylvania, United States
Brigham and Women's Hosp
🇺🇸Boston, Massachusetts, United States
Boston Med Ctr / Clinical Research Office
🇺🇸Boston, Massachusetts, United States
Houston Clinical Research Network / Southhampton Med Group
🇺🇸Houston, Texas, United States
1917 Research Clinic
🇺🇸Birmingham, Alabama, United States
AIDS Research Consortium of Atlanta
🇺🇸Atlanta, Georgia, United States
Akron City Hospital
🇺🇸Akron, Ohio, United States
Thomas Jefferson Univ
🇺🇸Philadelphia, Pennsylvania, United States
Kaiser Permanente / Infectious Disease
🇺🇸Los Angeles, California, United States
Tower ID Med Associates
🇺🇸Los Angeles, California, United States
Ponce de Leon Ctr
🇺🇸Atlanta, Georgia, United States
Ctr for AIDS Research / Education and Service (CARES)
🇺🇸Sacramento, California, United States
HIV Clinical Research
🇺🇸Fort Lauderdale, Florida, United States
Rush Presbyterian St Lukes Med Ctr
🇺🇸Chicago, Illinois, United States
St Vincents Hosp and Med Ctr / Div of HIV Med
🇺🇸New York, New York, United States
San Francisco Gen Hosp / UCSF AIDS Program
🇺🇸San Francisco, California, United States
Kansas City Free Health Clinic
🇺🇸Kansas City, Missouri, United States
SUNY / Health Science Ctr at Brooklyn
🇺🇸Brooklyn, New York, United States
Univ of Miami School of Medicine
🇺🇸Miami, Florida, United States
Northwestern Univ Med School
🇺🇸Chicago, Illinois, United States
Natl Naval Med Ctr / Special Immunology Clinic
🇺🇸Bethesda, Maryland, United States
Univ Health Ctr 7D
🇺🇸Detroit, Michigan, United States
Garden State Infectious Diseases / E I P Kennedy Health Sys
🇺🇸Voorhees, New Jersey, United States
CRIA
🇺🇸New York, New York, United States
Univ of Utah School Of Medicine / Div of Infec Disease
🇺🇸Salt Lake City, Utah, United States
Education & Research Building
🇺🇸Camden, New Jersey, United States
Albany Med College / Div of HIV Medicine
🇺🇸Albany, New York, United States
New York Hosp of Queens / AIDS Ctr
🇺🇸Flushing, New York, United States