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Sponsored by: |
Glaxo Wellcome |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002442 |
The purpose of this study is to compare the safety and effectiveness of 2 dosing schedules (once daily vs twice daily) of lamivudine (3TC) given with stavudine (d4T) and either indinavir (IDV) or nelfinavir (NFV) for 24 weeks.
Condition | Intervention | Phase |
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HIV Infections |
Drug: Indinavir sulfate Drug: Nelfinavir mesylate Drug: Lamivudine Drug: Stavudine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Safety Study |
Official Title: | A Phase II, Open-Label, Randomized Study of the Efficacy and Safety of Epivir 150 Mg BID Versus Epivir 300 Mg Once-Daily When Administered for 24 Weeks in Combination With FDA-Approved Dosage Regimens of Zerit and Either Crixivan or Viracept in Subjects With HIV-1 Infection |
Study Start Date: | June 1999 |
Patients are randomized to 1 of 2 groups. Group 1 receives 3TC qd plus d4T plus either IDV or NFV. Group 2 receives 3TC bid plus d4T plus either IDV or NFV. Patients are evaluated for drug tolerance, medication adherence, and genotypic and phenotypic resistance.
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:
This must be their first anti-HIV drug regimen.)
Exclusion Criteria
Patients will not be eligible for this study if they:
United States, California | |
Palo Alto Veterans Affairs Health Care System | |
Palo Alto, California, United States, 94304 | |
AIDS Healthcare Foundation | |
Los Angeles, California, United States, 90027 | |
United States, District of Columbia | |
Dupont Circle Physicians Group | |
Washington, District of Columbia, United States, 200091104 | |
United States, Florida | |
IDC Research Initiative | |
Altamonte Springs, Florida, United States, 32701 | |
Steinhart Medical Associates | |
Miami, Florida, United States, 33133 | |
North Broward Hosp District | |
Fort Lauderdale, Florida, United States, 33316 | |
United States, Illinois | |
Northwestern Univ Med School | |
Chicago, Illinois, United States, 60611 | |
United States, New York | |
St Lukes - Roosevelt Hosp Ctr | |
New York, New York, United States, 10019 | |
Saint Vincents Hosp | |
New York, New York, United States, 10011 | |
United States, Pennsylvania | |
MCP Hahnemann Univ Hosp | |
Philadelphia, Pennsylvania, United States, 19102 | |
United States, Texas | |
Univ TX Galveston Med Branch | |
Galveston, Texas, United States, 77550 | |
Southwest Infectious Disease Association / PA | |
Dallas, Texas, United States, 75225 |
Study ID Numbers: | 225C, COLA 4005 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002442 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Drug Therapy, Combination Zidovudine Drug Administration Schedule Stavudine HIV Protease Inhibitors Lamivudine |
Indinavir Dosage Forms Nelfinavir Reverse Transcriptase Inhibitors Anti-HIV Agents |
Antimetabolites HIV Protease Inhibitors Sexually Transmitted Diseases, Viral Anti-HIV Agents Stavudine Indinavir Acquired Immunodeficiency Syndrome Zidovudine Lamivudine Antiviral Agents |
Immunologic Deficiency Syndromes Protease Inhibitors Reverse Transcriptase Inhibitors Virus Diseases Anti-Retroviral Agents HIV Infections Sexually Transmitted Diseases Nelfinavir Retroviridae Infections |
Antimetabolites Anti-Infective Agents Communicable Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Stavudine Indinavir Molecular Mechanisms of Pharmacological Action Lamivudine Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Nelfinavir Retroviridae Infections |
Nucleic Acid Synthesis Inhibitors HIV Protease Inhibitors RNA Virus Infections Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Protease Inhibitors Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections |