Safety and Effectiveness of an Anti-HIV Drug Combination Taken Twice Daily
- Conditions
- HIV Infections
- Registration Number
- NCT00002241
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The purpose of this study is to see whether taking indinavir (IDV) plus ritonavir (RTV) plus stavudine (d4T) plus lamivudine (3TC) 2 times each day is safe and can lower the level of HIV in the blood.
- Detailed Description
Patients take IDV plus RTV plus d4T plus 3TC twice daily for 24 weeks. Every 4 weeks, patients have physical exams and laboratory tests of blood and urine, and CD4 cell counts and plasma viral RNA are measured. At Week 24, the proportion of patients with plasma viral RNA below 400 copies/ml is determined to identify any clinically meaningful antiretroviral activity for the drug regimen. An observed response proportion of 80% or higher will be considered clinically meaningful.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
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 (18)
Univ of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Apogee Med Group
🇺🇸San Diego, California, United States
Univ of California at San Francisco Gen Hosp
🇺🇸San Francisco, California, United States
HIV Institute / Davies Med Ctr
🇺🇸San Francisco, California, United States
Kaiser Foundation Hospital
🇺🇸San Francisco, California, United States
Univ of Miami School of Medicine
🇺🇸Miami, Florida, United States
AIDS Research Alliance - Chicago
🇺🇸Chicago, Illinois, United States
Tulane Univ School of Medicine
🇺🇸New Orleans, Louisiana, United States
CRI New England
🇺🇸Brookline, Massachusetts, United States
Bronx Lebanon Hosp Ctr
🇺🇸Bronx, New York, United States
Scroll for more (8 remaining)Univ of Alabama at Birmingham🇺🇸Birmingham, Alabama, United States