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.
Sponsor:
Glaxo Wellcome
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00004852
First received: March 2, 2000
Last updated: June 23, 2005
Last verified: August 2000
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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 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by NIH AIDS Clinical Trials Information Service:
| 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 |
Criteria
Inclusion Criteria
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).
Exclusion Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004852
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| United States, Arizona | |
| Phoenix Body Positive | |
| Phoenix, Arizona, United States, 85016 | |
| United States, California | |
| Pacific Oaks Research | |
| Beverly Hills, California, United States, 90211 | |
| AIDS Healthcare Foundation | |
| Los Angeles, California, United States, 900276069 | |
| Tower ID Med Associates | |
| Los Angeles, California, United States, 90048 | |
| Kaiser Foundation Hospital | |
| San Francisco, California, United States, 94118 | |
| Davies Med Ctr / c/o HIV Institute | |
| San Francisco, California, United States, 94114 | |
| Harbor - UCLA Med Ctr | |
| Torrance, California, United States, 90509 | |
| 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 | |
| IDC Research Initiative | |
| Altamonte Springs, Florida, United States, 32701 | |
| Bach and Godofsky | |
| Bradenton, Florida, United States, 34205 | |
| TheraFirst Med Ctrs Inc | |
| Fort Lauderdale, Florida, United States, 33308 | |
| The Coleman Institute Inc | |
| Fort Lauderdale, Florida, United States, 33334 | |
| North Broward Hosp District | |
| Fort Lauderdale, Florida, United States, 33316 | |
| 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 | |
| East Orange Veterans Administration Med Ctr | |
| East Orange, New Jersey, United States, 07018 | |
| ID Care Inc | |
| New Brunswick, New Jersey, United States, 08901 | |
| ID Care Inc | |
| Princeton, New Jersey, United States, 08540 | |
| ID Care Inc | |
| Randolph, New Jersey, United States, 07869 | |
| ID Care Inc | |
| Somerville, New Jersey, United States, 08876 | |
| United States, New York | |
| Albany Med College / Div of HIV Medicine | |
| Albany, New York, United States, 12208 | |
| 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 | |
| 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 | |
| Methodist Healthcare | |
| Memphis, Tennessee, United States, 38104 | |
| Vanderbilt Univ Med Ctr | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| Dr David Donnell | |
| Dallas, Texas, United States, 75219 | |
| Nelson-Tebedo Community Clinic | |
| Dallas, Texas, United States, 75219 | |
| Univ of Texas Med Branch | |
| Galveston, Texas, United States, 77555 | |
| Baylor College of Medicine / Dept of Medicine | |
| Houston, Texas, United States, 770303498 | |
| Univ of Texas / Med School at Houston | |
| Houston, Texas, United States, 77030 | |
| Montrose Clinic | |
| Houston, Texas, United States, 77006 | |
| Univ of Texas Health Sciences Ctr | |
| San Antonio, Texas, United States, 782847838 | |
| United States, Virginia | |
| Hampton Roads Med Specialists | |
| Hampton, Virginia, United States, 23666 | |
| Argentina | |
| Hosp Muniz | |
| Buenos Aires, Argentina | |
| CAICI | |
| Rosario - Santa Fe, Argentina | |
| Brazil | |
| Universidade de Campinas | |
| Campinas - SP, Brazil | |
| Hosp Evandro Chagas Fioernz | |
| Manguinhos RJ, Brazil | |
| Hosp Univ Pedro Ernesto / Univ Estadual do RJ | |
| Rio de Janeiro - RJ, Brazil | |
| Hosp Univ Clementino Fraga Filho | |
| Rio de Janeiro - RJ, Brazil | |
| Hosp Sao Paulo da Universidade Federal de Sao Paulo | |
| Sao Paulo - SP, 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 | |
| Caguas Regional Hosp | |
| Caguas, Puerto Rico, 00726 | |
| Hosp San Cristobal-Edif A | |
| Cotto Laurel, Puerto Rico, 00780 | |
| Carlos Leon-Valiente MD | |
| Guaynabo, Puerto Rico, 00966 | |
| Ramon Ramirez Ronda MD | |
| Mayaguez, Puerto Rico, 00680 | |
| San Juan AIDS Program | |
| Santurce, Puerto Rico, 00908 | |
Sponsors and Collaborators
Glaxo Wellcome
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00004852 History of Changes |
| Other Study ID Numbers: | 225D, EPV2000 1 |
| Study First Received: | March 2, 2000 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
|
HIV-1 Drug Therapy, Combination Zidovudine Drug Administration Schedule Lamivudine Genotype |
Phenotype Reverse Transcriptase Inhibitors Anti-HIV Agents Viral Load efavirenz |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Zidovudine Lamivudine |
Reverse Transcriptase Inhibitors Efavirenz Anti-HIV Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013