A Study to Compare the Safety and Effectiveness of Two Dosing Schedules of Lamivudine in Combination With Two Other Anti-HIV Drugs
- Conditions
- HIV Infections
- Registration Number
- NCT00002442
- Lead Sponsor
- Glaxo Wellcome
- Brief Summary
The purpose of this study is to compare the safety and effectiveness of 2 dosing schedules (once daily vs twice daily) of lamivudine (3TC) given with stavudine (d4T) and either indinavir (IDV) or nelfinavir (NFV) for 24 weeks.
- Detailed Description
Patients are randomized to 1 of 2 groups. Group 1 receives 3TC qd plus d4T plus either IDV or NFV. Group 2 receives 3TC bid plus d4T plus either IDV or NFV. Patients are evaluated for drug tolerance, medication adherence, and genotypic and phenotypic resistance.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
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 (12)
Southwest Infectious Disease Association / PA
🇺🇸Dallas, Texas, United States
Univ TX Galveston Med Branch
🇺🇸Galveston, Texas, United States
St Lukes - Roosevelt Hosp Ctr
🇺🇸New York, New York, United States
North Broward Hosp District
🇺🇸Fort Lauderdale, Florida, United States
Palo Alto Veterans Affairs Health Care System
🇺🇸Palo Alto, California, United States
Northwestern Univ Med School
🇺🇸Chicago, Illinois, United States
Saint Vincents Hosp
🇺🇸New York, New York, United States
Dupont Circle Physicians Group
🇺🇸Washington, District of Columbia, United States
Steinhart Medical Associates
🇺🇸Miami, Florida, United States
MCP Hahnemann Univ Hosp
🇺🇸Philadelphia, Pennsylvania, United States
IDC Research Initiative
🇺🇸Altamonte Springs, Florida, United States
AIDS Healthcare Foundation
🇺🇸Los Angeles, California, United States