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| Sponsor: | Glaxo Wellcome |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00004852 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Efavirenz Drug: Lamivudine Drug: Zidovudine |
Phase II |
| 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 Date: | 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients may be eligible for this study if they:
Exclusion Criteria
Patients will not be eligible for this study if they:
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| Phoenix Body Positive | |
| Phoenix, Arizona, United States, 85016 | |
| United States, California | |
| Davies Med Ctr / c/o HIV Institute | |
| San Francisco, California, United States, 94114 | |
| Harbor - UCLA Med Ctr | |
| Torrance, California, United States, 90509 | |
| Kaiser Foundation Hospital | |
| San Francisco, California, United States, 94118 | |
| Pacific Oaks Research | |
| Beverly Hills, California, United States, 90211 | |
| Tower ID Med Associates | |
| Los Angeles, California, United States, 90048 | |
| AIDS Healthcare Foundation | |
| Los Angeles, California, United States, 900276069 | |
| United States, District of Columbia | |
| Georgetown Univ Med Ctr | |
| Washington, District of Columbia, United States, 20007 | |
| George Washington Univ Med Ctr | |
| Washington, District of Columbia, United States, 20037 | |
| United States, Florida | |
| TheraFirst Med Ctrs Inc | |
| Fort Lauderdale, Florida, United States, 33308 | |
| North Broward Hosp District | |
| Fort Lauderdale, Florida, United States, 33316 | |
| IDC Research Initiative | |
| Altamonte Springs, Florida, United States, 32701 | |
| Bach and Godofsky | |
| Bradenton, Florida, United States, 34205 | |
| The Coleman Institute Inc | |
| Fort Lauderdale, Florida, United States, 33334 | |
| The Coleman Institute Inc | |
| Fort Pierce, Florida, United States, 34950 | |
| United States, Georgia | |
| Kaiser Permanente Infectious Diseases | |
| Atlanta, Georgia, United States, 30339 | |
| United States, Illinois | |
| AIDS Research Alliance - Chicago | |
| Chicago, Illinois, United States, 60657 | |
| United States, Indiana | |
| Infectious Disease of Indiana | |
| Indianapolis, Indiana, United States, 46218 | |
| United States, Kentucky | |
| Univ of Kentucky Med Ctr | |
| Lexington, Kentucky, United States, 40536 | |
| United States, Louisiana | |
| Tulane Univ School of Medicine | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Massachusetts | |
| Boston Med Ctr / Evans - 556 | |
| Boston, Massachusetts, United States, 021182393 | |
| United States, Missouri | |
| Antibiotic Research Associates | |
| Kansas City, Missouri, United States, 64132 | |
| United States, New Jersey | |
| ID Care Inc | |
| Somerville, New Jersey, United States, 08876 | |
| East Orange Veterans Administration Med Ctr | |
| East Orange, New Jersey, United States, 07018 | |
| ID Care Inc | |
| Princeton, New Jersey, United States, 08540 | |
| ID Care Inc | |
| New Brunswick, New Jersey, United States, 08901 | |
| ID Care Inc | |
| Randolph, New Jersey, United States, 07869 | |
| United States, New York | |
| North Shore Univ Hosp / Div of Infectious Diseases | |
| Manhasset, New York, United States, 11030 | |
| St Lukes / Roosevelt Hosp / HIV Center | |
| New York, New York, United States, 10019 | |
| Albany Med College / Div of HIV Medicine | |
| Albany, New York, United States, 12208 | |
| St Vincents Hosp / Clinical Research Program | |
| New York, New York, United States, 10011 | |
| United States, Ohio | |
| Ohio State Univ Hosp Clinic | |
| Columbus, Ohio, United States, 432101228 | |
| United States, Oklahoma | |
| Associates in Med and Mental Health | |
| Tulsa, Oklahoma, United States, 74114 | |
| Oklahoma State University / College of Osteopathic Medicine | |
| Tulsa, Oklahoma, United States, 74107 | |
| United States, Rhode Island | |
| Miriam Hosp / Brown Univ | |
| Providence, Rhode Island, United States, 02906 | |
| United States, Tennessee | |
| Univ of Tennessee | |
| Memphis, Tennessee, United States, 38163 | |
| Vanderbilt Univ Med Ctr | |
| Nashville, Tennessee, United States, 37203 | |
| Methodist Healthcare | |
| Memphis, Tennessee, United States, 38104 | |
| United States, Texas | |
| Univ of Texas / Med School at Houston | |
| Houston, Texas, United States, 77030 | |
| Nelson-Tebedo Community Clinic | |
| Dallas, Texas, United States, 75219 | |
| Baylor College of Medicine / Dept of Medicine | |
| Houston, Texas, United States, 770303498 | |
| Dr David Donnell | |
| Dallas, Texas, United States, 75219 | |
| Univ of Texas Health Sciences Ctr | |
| San Antonio, Texas, United States, 782847838 | |
| Univ of Texas Med Branch | |
| Galveston, Texas, United States, 77555 | |
| Montrose Clinic | |
| Houston, Texas, United States, 77006 | |
| United States, Virginia | |
| Hampton Roads Med Specialists | |
| Hampton, Virginia, United States, 23666 | |
| Argentina | |
| Hosp Muniz | |
| Buenos Aires, Argentina | |
| CAICI | |
| Rosario - Santa Fe, Argentina | |
| Brazil | |
| 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 | |
| Canada, Alberta | |
| Southern Alberta HIV Clinic / Foothills Hosp | |
| Calgary, Alberta, Canada | |
| Canada, British Columbia | |
| Saint Paul's Hosp | |
| Vancouver, British Columbia, Canada | |
| Canada, Ontario | |
| Sunnybrook Health Science Centre | |
| Toronto, Ontario, Canada | |
| Toronto Gen Hosp | |
| Toronto, Ontario, Canada | |
| Wellesley/Central Site / St Michael's Hospital | |
| Toronto, Ontario, Canada | |
| Canada, Quebec | |
| Clinique Medicale L'Actuele | |
| Montreal, Quebec, Canada | |
| Clinique Medicale du Quartier Latin | |
| Montreal, Quebec, Canada | |
| Centre Hospitalier Universitaire de Quebec | |
| Ste Foy, Quebec, Canada | |
| Puerto Rico | |
| San Juan AIDS Program | |
| Santurce, Puerto Rico, 00908 | |
| Ramon Ramirez Ronda MD | |
| Mayaguez, Puerto Rico, 00680 | |
| Carlos Leon-Valiente MD | |
| Guaynabo, Puerto Rico, 00966 | |
| Hosp San Cristobal-Edif A | |
| Cotto Laurel, Puerto Rico, 00780 | |
| Caguas Regional Hosp | |
| Caguas, Puerto Rico, 00726 | |
More Information
| Study ID Numbers: | 225D, EPV2000 1 |
| Study First Received: | March 2, 2000 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00004852 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
HIV-1 Drug Therapy, Combination Zidovudine Drug Administration Schedule Lamivudine Genotype |
Phenotype Reverse Transcriptase Inhibitors Anti-HIV Agents Viral Load efavirenz |
|
Antimetabolites Anti-Infective Agents Communicable Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Zidovudine Lamivudine Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections Nucleic Acid Synthesis Inhibitors |
Efavirenz RNA Virus Infections Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections |