Safety and Effectiveness of Lamivudine When Given Once a Day Versus Twice a Day in Combination With Other Anti-HIV Drugs in HIV-Infected Adults Who Have Never Received Anti-HIV Drugs
- Conditions
- HIV Infections
- Registration Number
- NCT00004852
- Lead Sponsor
- Glaxo Wellcome
- Brief Summary
The purpose of this study is to look at the safety and effectiveness of receiving lamivudine (3TC) once a day versus twice a day as part of an anti-HIV drug combination.
- Detailed Description
Patients are randomized to receive the same total dosage of 3TC either twice a day (Group 1) or once a day (Group 2) in combination with ZDV and EFV over 48 weeks. Viral load measurements will be performed at Weeks 4, 8, 12, 16, 20, 24, and every 8 weeks thereafter.
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 (62)
Univ of Texas / Med School at Houston
🇺🇸Houston, Texas, United States
Harbor - UCLA Med Ctr
🇺🇸Torrance, California, United States
Bach and Godofsky
🇺🇸Bradenton, Florida, United States
Davies Med Ctr / c/o HIV Institute
🇺🇸San Francisco, California, United States
Tower ID Med Associates
🇺🇸Los Angeles, California, United States
Kaiser Foundation Hospital
🇺🇸San Francisco, California, United States
Pacific Oaks Research
🇺🇸Beverly Hills, California, United States
Phoenix Body Positive
🇺🇸Phoenix, Arizona, United States
AIDS Research Alliance - Chicago
🇺🇸Chicago, Illinois, United States
Tulane Univ School of Medicine
🇺🇸New Orleans, Louisiana, United States
TheraFirst Med Ctrs Inc
🇺🇸Fort Lauderdale, Florida, United States
Montrose Clinic
🇺🇸Houston, Texas, United States
Baylor College of Medicine / Dept of Medicine
🇺🇸Houston, Texas, United States
North Broward Hosp District
🇺🇸Fort Lauderdale, Florida, United States
Univ of Kentucky Med Ctr
🇺🇸Lexington, Kentucky, United States
East Orange Veterans Administration Med Ctr
🇺🇸East Orange, New Jersey, United States
Miriam Hosp / Brown Univ
🇺🇸Providence, Rhode Island, United States
St Vincents Hosp / Clinical Research Program
🇺🇸New York, New York, United States
North Shore Univ Hosp / Div of Infectious Diseases
🇺🇸Manhasset, New York, United States
Associates in Med and Mental Health
🇺🇸Tulsa, Oklahoma, United States
Dr David Donnell
🇺🇸Dallas, Texas, United States
Nelson-Tebedo Community Clinic
🇺🇸Dallas, Texas, United States
Hosp Evandro Chagas Fioernz
🇧🇷Manguinhos RJ, Brazil
Hampton Roads Med Specialists
🇺🇸Hampton, Virginia, United States
Hosp Univ Clementino Fraga Filho
🇧🇷Rio de Janeiro - RJ, Brazil
Vanderbilt Univ Med Ctr
🇺🇸Nashville, Tennessee, United States
Univ of Texas Health Sciences Ctr
🇺🇸San Antonio, Texas, United States
CAICI
🇦🇷Rosario - Santa Fe, Argentina
Univ of Texas Med Branch
🇺🇸Galveston, Texas, United States
Toronto Gen Hosp
🇨🇦Toronto, Ontario, Canada
Wellesley/Central Site / St Michael's Hospital
🇨🇦Toronto, Ontario, Canada
Clinique Medicale L'Actuele
🇨🇦Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Quebec
🇨🇦Ste Foy, Quebec, Canada
St Lukes / Roosevelt Hosp / HIV Center
🇺🇸New York, New York, United States
The Coleman Institute Inc
🇺🇸Fort Pierce, Florida, United States
Saint Paul's Hosp
🇨🇦Vancouver, British Columbia, Canada
Sunnybrook Health Science Centre
🇨🇦Toronto, Ontario, Canada
Clinique Medicale du Quartier Latin
🇨🇦Montreal, Quebec, Canada
Carlos Leon-Valiente MD
🇵🇷Guaynabo, Puerto Rico
Hosp San Cristobal-Edif A
🇵🇷Cotto Laurel, Puerto Rico
San Juan AIDS Program
🇵🇷Santurce, Puerto Rico
Ramon Ramirez Ronda MD
🇵🇷Mayaguez, Puerto Rico
Georgetown Univ Med Ctr
🇺🇸Washington, District of Columbia, United States
Kaiser Permanente Infectious Diseases
🇺🇸Atlanta, Georgia, United States
Universidade de Campinas
🇧🇷Campinas - SP, Brazil
IDC Research Initiative
🇺🇸Altamonte Springs, Florida, United States
Hosp Univ Pedro Ernesto / Univ Estadual do RJ
🇧🇷Rio de Janeiro - RJ, Brazil
Infectious Disease of Indiana
🇺🇸Indianapolis, Indiana, United States
George Washington Univ Med Ctr
🇺🇸Washington, District of Columbia, United States
Antibiotic Research Associates
🇺🇸Kansas City, Missouri, United States
Boston Med Ctr / Evans - 556
🇺🇸Boston, Massachusetts, United States
Albany Med College / Div of HIV Medicine
🇺🇸Albany, New York, United States
Univ of Tennessee
🇺🇸Memphis, Tennessee, United States
Ohio State Univ Hosp Clinic
🇺🇸Columbus, Ohio, United States
Oklahoma State University / College of Osteopathic Medicine
🇺🇸Tulsa, Oklahoma, United States
Hosp Muniz
🇦🇷Buenos Aires, Argentina
ID Care Inc
🇺🇸Somerville, New Jersey, United States
Hosp Sao Paulo da Universidade Federal de Sao Paulo
🇧🇷Sao Paulo - SP, Brazil
Southern Alberta HIV Clinic / Foothills Hosp
🇨🇦Calgary, Alberta, Canada
Methodist Healthcare
🇺🇸Memphis, Tennessee, United States
Caguas Regional Hosp
🇵🇷Caguas, Puerto Rico
AIDS Healthcare Foundation
🇺🇸Los Angeles, California, United States