The Safety and Effectiveness of Nevirapine Plus Lamivudine Plus Other Anti-HIV Drugs
- Conditions
- HIV Infections
- Registration Number
- NCT00002368
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
To evaluate the tolerance, safety, and effectiveness of Viramune in preventing clinical AIDS progression events or death when used in combination with Lamivudine and background nucleoside therapy.
- Detailed Description
Eligible patients will be randomized to treatment with either 1) open-label 3TC twice daily plus Viramune once daily for 2 weeks and then with Viramune twice daily; or 2) open label 3TC twice daily plus Viramune placebo once daily for 2 weeks and then twice daily Viramune. Patients will start Viramune and 3TC on study day 0. Patients will be evaluated for development of AIDS progression events at months 1, 2, 3, and 4, and every 2 months thereafter until 18 months after the last patient is enrolled or 24 months, whichever occurs first.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2000
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 (52)
Drug Research and Analysis Corp
🇺🇸Montgomery, Alabama, United States
Dr G Michael Wool
🇺🇸Los Angeles, California, United States
UCLA School of Medicine / Ctr for Research and Education
🇺🇸Los Angeles, California, United States
AIDS Research Ctr / Palo Alto VA Health Care System
🇺🇸Palo Alto, California, United States
AIDS Community Research Consortium
🇺🇸Redwood City, California, United States
ViRx Inc
🇺🇸San Francisco, California, United States
San Francisco Gen Hosp / UCSF AIDS Program
🇺🇸San Francisco, California, United States
Harbor - UCLA Med Ctr
🇺🇸Torrance, California, United States
Infectious Disease Specialists
🇺🇸Colorado Springs, Colorado, United States
Denver Public Health
🇺🇸Denver, Colorado, United States
Scroll for more (42 remaining)Drug Research and Analysis Corp🇺🇸Montgomery, Alabama, United States