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
A Phase II/III 48-Week, Randomized, Double-Blind, Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Lamivudine 300mg Once Daily Vs. Lamivudine 150mg BID in Combination With Zidovudine 300mg BID and Efavirenz 600mg Once Daily in Antiretroviral-Naive Adults With HIV-1 Infection
2 other identifiers
interventional
N/A
5 countries
66
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
66 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 1999
CompletedFirst Submitted
Initial submission to the registry
March 2, 2000
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
August 1, 2000
March 2, 2000
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients may be eligible for this study if they:
- Are 18 years of age or older.
- Are HIV-positive.
- Have a viral load (level of HIV in the blood) of at least 400 copies/ml within 21 days of study entry.
- Have a CD4 count greater than 100 cells/mm3 within 21 days of study entry.
- Agree to practice abstinence or use effective barrier methods of birth control (or, if patient is a woman, unable to have children).
You may not qualify if:
- Patients will not be eligible for this study if they:
- Have taken any antiretroviral (anti-HIV) agent.
- Are pregnant or breast-feeding.
- Are unable to absorb food or have trouble taking medicines by mouth.
- Abuse alcohol or drugs to an extent that may make study participation difficult.
- Are not likely to be able to complete the 48 weeks of study treatment.
- Have a history of pancreatitis (inflamed pancreas) or hepatitis within the last 6 months or any evidence of liver disease.
- Have received an investigational vaccine within the past 3 months or have received gene therapy.
- Have a severe medical condition such as diabetes or heart trouble.
- Have been diagnosed with AIDS.
- Have had radiation therapy or chemotherapy within 30 days of study entry, except for treatment of Kaposi's sarcoma.
- Are taking medications that affect the immune system within 30 days of study entry.
- Are taking medications that may interact with the study drugs.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Glaxo Wellcomelead
Study Sites (66)
Phoenix Body Positive
Phoenix, Arizona, 85016, United States
Pacific Oaks Research
Beverly Hills, California, 90211, United States
AIDS Healthcare Foundation
Los Angeles, California, 900276069, United States
Tower ID Med Associates
Los Angeles, California, 90048, United States
Davies Med Ctr / c/o HIV Institute
San Francisco, California, 94114, United States
Kaiser Foundation Hospital
San Francisco, California, 94118, United States
Harbor - UCLA Med Ctr
Torrance, California, 90509, United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007, United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037, United States
IDC Research Initiative
Altamonte Springs, Florida, 32701, United States
Bach and Godofsky
Bradenton, Florida, 34205, United States
TheraFirst Med Ctrs Inc
Fort Lauderdale, Florida, 33308, United States
North Broward Hosp District
Fort Lauderdale, Florida, 33316, United States
The Coleman Institute Inc
Fort Lauderdale, Florida, 33334, United States
The Coleman Institute Inc
Ft. Pierce, Florida, 34950, United States
Kaiser Permanente Infectious Diseases
Atlanta, Georgia, 30339, United States
AIDS Research Alliance - Chicago
Chicago, Illinois, 60657, United States
Infectious Disease of Indiana
Indianapolis, Indiana, 46218, United States
Univ of Kentucky Med Ctr
Lexington, Kentucky, 40536, United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112, United States
Boston Med Ctr / Evans - 556
Boston, Massachusetts, 021182393, United States
Antibiotic Research Associates
Kansas City, Missouri, 64132, United States
East Orange Veterans Administration Med Ctr
East Orange, New Jersey, 07018, United States
ID Care Inc
New Brunswick, New Jersey, 08901, United States
ID Care Inc
Princeton, New Jersey, 08540, United States
ID Care Inc
Randolph Township, New Jersey, 07869, United States
ID Care Inc
Somerville, New Jersey, 08876, United States
Albany Med College / Div of HIV Medicine
Albany, New York, 12208, United States
North Shore Univ Hosp / Div of Infectious Diseases
Manhasset, New York, 11030, United States
St Vincents Hosp / Clinical Research Program
New York, New York, 10011, United States
St Lukes / Roosevelt Hosp / HIV Center
New York, New York, 10019, United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228, United States
Oklahoma State University / College of Osteopathic Medicine
Tulsa, Oklahoma, 74107, United States
Associates in Med and Mental Health
Tulsa, Oklahoma, 74114, United States
Miriam Hosp / Brown Univ
Providence, Rhode Island, 02906, United States
Methodist Healthcare
Memphis, Tennessee, 38104, United States
Univ of Tennessee
Memphis, Tennessee, 38163, United States
Vanderbilt Univ Med Ctr
Nashville, Tennessee, 37203, United States
Dr David Donnell
Dallas, Texas, 75219, United States
Nelson-Tebedo Community Clinic
Dallas, Texas, 75219, United States
Univ of Texas Med Branch
Galveston, Texas, 77555, United States
Montrose Clinic
Houston, Texas, 77006, United States
Baylor College of Medicine / Dept of Medicine
Houston, Texas, 770303498, United States
Univ of Texas / Med School at Houston
Houston, Texas, 77030, United States
Univ of Texas Health Sciences Ctr
San Antonio, Texas, 782847838, United States
Hampton Roads Med Specialists
Hampton, Virginia, 23666, United States
Hosp Muniz
Buenos Aires, Argentina
CAICI
Rosario - Santa Fe, Argentina
Universidade de Campinas
Campinas - SP, Brazil
Hosp Evandro Chagas Fioernz
Manguinhos RJ, Brazil
Hosp Univ Clementino Fraga Filho
Rio de Janeiro - RJ, Brazil
Hosp Univ Pedro Ernesto / Univ Estadual do RJ
Rio de Janeiro - RJ, Brazil
Hosp Sao Paulo da Universidade Federal de Sao Paulo
Sao Paulo - SP, Brazil
Southern Alberta HIV Clinic / Foothills Hosp
Calgary, Alberta, Canada
Saint Paul's Hosp
Vancouver, British Columbia, Canada
Sunnybrook Health Science Centre
Toronto, Ontario, Canada
Toronto Gen Hosp
Toronto, Ontario, Canada
Wellesley/Central Site / St Michael's Hospital
Toronto, Ontario, Canada
Clinique Medicale du Quartier Latin
Montreal, Quebec, Canada
Clinique Medicale L'Actuele
Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Quebec
Ste Foy, Quebec, Canada
Caguas Regional Hosp
Caguas, 00726, Puerto Rico
Hosp San Cristobal-Edif A
Cotto Laurel, 00780, Puerto Rico
Carlos Leon-Valiente MD
Guaynabo, 00966, Puerto Rico
Ramon Ramirez Ronda MD
Mayagüez, 00680, Puerto Rico
San Juan AIDS Program
Santurce, 00908, Puerto Rico