A Study of Indinavir Taken With or Without DMP 266
- Conditions
- HIV Infections
- Registration Number
- NCT00002393
- Lead Sponsor
- Dupont Merck
- Brief Summary
The purpose of this study is to see if it is safe and effective to add DMP 266 to an anti-HIV treatment program of indinavir and nucleoside reverse transcriptase inhibitors (NRTIs).
- Detailed Description
In this double-blind, placebo-controlled study, 300 patients are randomized to 1 or 2 reverse transcriptase inhibitors of their choice plus blinded therapy on Arm A or B as follows:
Arm A: DMP 266 placebo plus indinavir. Arm B: DMP 266 plus indinavir. After 16 weeks, patients may switch the NRTI portion of their regimen if they meet a treatment failure criterion. After the completion of the 24-week period, patients have the option to continue on open-label DMP 266 and indinavir.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (12)
Tulane Univ / Tulane / LSU Clinical Trials Unit
🇺🇸New Orleans, Louisiana, United States
Vanderbilt Univ
🇺🇸Nashville, Tennessee, United States
Chicago Ctr for Clinical Research
🇺🇸Chicago, Illinois, United States
Ottawa Gen Hosp
🇨🇦Ottawa, Ontario, Canada
Med College of Georgia
🇺🇸Augusta, Georgia, United States
Mount Sinai Med Ctr
🇺🇸New York, New York, United States
Univ of Kentucky Med Ctr / Chandler Med Ctr
🇺🇸Lexington, Kentucky, United States
Univ of Rochester Med Ctr
🇺🇸Rochester, New York, United States
Southern Alberta HIV Clinic / Foot Hills Hosp
🇨🇦Calgary, Alberta, Canada
Kaiser Foundation Hospital
🇺🇸San Francisco, California, United States
Hampton Roads Med Specialists
🇺🇸Hampton, Virginia, United States
Univ of Puerto Rico School of Medicine
🇵🇷San Juan, Puerto Rico