A Study to Compare the Safety and Effectiveness of Indinavir Combined With Stavudine and Lamivudine
- Conditions
- HIV Infections
- Registration Number
- NCT00002424
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
This study will see how safe and effective against HIV the drugs L-756423 plus indinavir (IDV) are compared to just IDV when taken with stavudine (d4T) and lamivudine (3TC). The study will also see whether taking 1 large dose of L-756423/IDV once a day is as safe and effective as taking 2 smaller doses twice a day.
- Detailed Description
Patients are randomized to 1 of 4 treatment arms. In Group 1, patients receive a dose of L-756423/IDV once daily plus IDV placebo. In Group 3, patients receive a lower dose of L-756423/IDV twice daily (with the daily dosage equaling that of Group 1) plus IDV placebo. In Groups 2 and 4, patients receive equal dosages of IDV plus L-756423/IDV placebo. In all 4 groups L-756423 and IDV are blinded to the investigator and patient. All groups receive open-label d4T and 3TC. Patients routinely undergo a physical exam and have blood and urine tests to ensure the drugs' safety and tolerability, which will be evaluated by tabulation of adverse events and clinical assessment of laboratory data. In addition, CD4+ T cell and plasma viral RNA levels are measured to quantify the drugs' antiretroviral activity.
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 186
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 (16)
UCLA School of Medicine / Ctr for Research and Education
🇺🇸Los Angeles, California, United States
Georgetown Univ Med Ctr
🇺🇸Washington, District of Columbia, United States
ViRx / Dupont Circle Physicians Group
🇺🇸Washington, District of Columbia, United States
Associates in Research
🇺🇸Fort Myers, Florida, United States
Univ of Miami School of Medicine
🇺🇸Miami, Florida, United States
Grady Mem Hosp
🇺🇸Atlanta, Georgia, United States
Rush Presbyterian - Saint Luke's Med Ctr
🇺🇸Chicago, Illinois, United States
The CORE Ctr
🇺🇸Chicago, Illinois, United States
Univ of Kentucky Med Ctr
🇺🇸Lexington, Kentucky, United States
Univ of Kentucky
🇺🇸Lexington, Kentucky, United States
Scroll for more (6 remaining)UCLA School of Medicine / Ctr for Research and Education🇺🇸Los Angeles, California, United States