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 - Article Sustiva
Clinical Trial: 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
This study has been completed.
|Condition||Treatment or Intervention||Phase|
|HIV Infections || Drug: Efavirenz |
|Phase II |
MedlinePlus related topics: AIDS
Study Type: Interventional
Study Design: Treatment, Double-Blind, Safety Study
Official Title: 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
Study start: September 1999
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.
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
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).
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.
Phoenix Body Positive, Phoenix, Arizona, 85016, United States
Davies Med Ctr / c/o HIV Institute, San Francisco, California, 94114, United States
Harbor - UCLA Med Ctr, Torrance, California, 90509, United States
Kaiser Foundation Hospital, San Francisco, California, 94118, United States
Pacific Oaks Research, Beverly Hills, California, 90211, United States
Tower ID Med Associates, Los Angeles, California, 90048, United States
AIDS Healthcare Foundation, Los Angeles, California, 900276069, United States
District of Columbia
Georgetown Univ Med Ctr, Washington, District of Columbia, 20007, United States
George Washington Univ Med Ctr, Washington, District of Columbia, 20037, United States
TheraFirst Med Ctrs Inc, Fort Lauderdale, Florida, 33308, United States
North Broward Hosp District, Fort Lauderdale, Florida, 33316, United States
IDC Research Initiative, Altamonte Springs, Florida, 32701, United States
Bach and Godofsky, Bradenton, Florida, 34205, United States
The Coleman Institute Inc, Fort Lauderdale, Florida, 33334, United States
The Coleman Institute Inc, Fort 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
ID Care Inc, Somerville, New Jersey, 08876, United States
East Orange Veterans Administration Med Ctr, East Orange, New Jersey, 07018, United States
ID Care Inc, Princeton, New Jersey, 08540, United States
ID Care Inc, New Brunswick, New Jersey, 08901, United States
ID Care Inc, Randolph, New Jersey, 07869, United States
North Shore Univ Hosp / Div of Infectious Diseases, Manhasset, New York, 11030, United States
St Lukes / Roosevelt Hosp / HIV Center, New York, New York, 10019, United States
Albany Med College / Div of HIV Medicine, Albany, New York, 12208, United States
St Vincents Hosp / Clinical Research Program, New York, New York, 10011, United States
Ohio State Univ Hosp Clinic, Columbus, Ohio, 432101228, United States
Associates in Med and Mental Health, Tulsa, Oklahoma, 74114, United States
Oklahoma State University / College of Osteopathic Medicine, Tulsa, Oklahoma, 74107, United States
Miriam Hosp / Brown Univ, Providence, Rhode Island, 02906, United States
Univ of Tennessee, Memphis, Tennessee, 38163, United States
Vanderbilt Univ Med Ctr, Nashville, Tennessee, 37203, United States
Methodist Healthcare, Memphis, Tennessee, 38104, United States
Dr David Donnell, Dallas, Texas, 75219, United States
Nelson-Tebedo Community Clinic, Dallas, Texas, 75219, 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
Univ of Texas Med Branch, Galveston, Texas, 77555, United States
Montrose Clinic, Houston, Texas, 77006, United States
Hampton Roads Med Specialists, Hampton, Virginia, 23666, United States
Hosp Muniz, Buenos Aires, Argentina
CAICI, Rosario Santa Fe, Argentina
Hosp Evandro Chagas Fioernz, Manguinhos RJ, Brazil
Hosp Sao Paulo da Universidade Federal de Sao Paulo, Sao Paulo - SP, Brazil
Universidade de Campinas, Campinas - SP, Brazil
Hosp Univ Pedro Ernesto / Univ Estadual do RJ, Rio de Janeiro - RJ, Brazil
Hosp Univ Clementino Fraga Filho, Rio de Janeiro - RJ, Brazil
Southern Alberta HIV Clinic / Foothills Hosp, Calgary, Alberta, Canada
Canada, British Columbia
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 L'Actuele, Montreal, Quebec, Canada
Clinique Medicale du Quartier Latin, Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Quebec, Ste Foy, Quebec, Canada
San Juan AIDS Program, Santurce, 00908, Puerto Rico
Caguas Regional Hosp, Caguas, 00726, Puerto Rico
Carlos Leon-Valiente MD, Guaynabo, 00966, Puerto Rico
Hosp San Cristobal-Edif A, Cotto Laurel, 00780, Puerto Rico
Ramon Ramirez Ronda MD, Mayaguez, 00680, Puerto Rico
Record last reviewed: August 2000
Last Updated: October 13, 2004
Record first received: March 2, 2000
ClinicalTrials.gov Identifier: NCT00004852
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Cache Date: April 9, 2005