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Sponsored by: |
Glaxo Wellcome |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002203 |
The purpose of this study is to compare the safety and effectiveness of taking lamivudine (3TC) plus zidovudine (ZDV) plus a protease inhibitor (PI) with taking the 3TC/ZDV combination tablet (Combivir) plus a PI. This study also examines how well patients follow the dosing schedules for these drugs. Doctors believe that taking Combivir plus a PI may be as effective as taking 3TC plus ZDV plus a PI.
Condition | Intervention |
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HIV Infections |
Drug: Lamivudine/Zidovudine Drug: Lamivudine Drug: Zidovudine |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Safety Study |
Official Title: | A Randomized, Multicenter Study of Epivir 150 Mg Bid, Retrovir 200 Mg Tid and a Protease Inhibitor Vs 3TC 150 Mg/ZDV 300 Mg Fixed Dose Tablet Given Bid With a Protease Inhibitor in HIV-Infected Patients |
It is hypothesized that a fixed-dose 3TC/ZDV tablet given bid in combination with a protease inhibitor is clinically equivalent in its effect on plasma HIV-1 RNA level to a conventional regimen of 3TC, ZDV, and a protease inhibitor.
Patients are stratified according to their current protease inhibitor therapy and randomized to receive open-label therapy of 1 Combivir tablet bid (Arm II) or an equivalent dose of 3TC and ZDV (Arm I), plus their current protease inhibitor for 16 weeks.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Prior Medication:
Required:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
Radiation therapy.
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
Radiation therapy within 4 weeks of study entry.
United States, California | |
Tower Infectious Diseases / Med Associates Inc | |
Los Angeles, California, United States, 90048 | |
Pacific Oaks Med Ctr | |
Beverly Hills, California, United States, 90211 | |
United States, North Carolina | |
Univ of North Carolina Hosps | |
Chapel Hill, North Carolina, United States, 27599 | |
Carolinas Med Ctr | |
Charlotte, North Carolina, United States, 28232 | |
United States, Virginia | |
Infectious Diseases Physicians Inc | |
Annandale, Virginia, United States, 22003 | |
United States, Wisconsin | |
Univ of Wisconsin School of Medicine | |
Madison, Wisconsin, United States, 53792 | |
Puerto Rico | |
San Juan AIDS Program | |
Santurce, Puerto Rico, 00907 |
Study ID Numbers: | 280A, NZTA4001 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002203 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Drug Therapy, Combination Zidovudine HIV Protease Inhibitors CD4 Lymphocyte Count CD4-CD8 Ratio |
Lamivudine Patient Compliance Reverse Transcriptase Inhibitors Anti-HIV Agents Viral Load |
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral HIV Protease Inhibitors Anti-HIV Agents Acquired Immunodeficiency Syndrome Zidovudine Lamivudine Antiviral Agents |
Immunologic Deficiency Syndromes Reverse Transcriptase Inhibitors Protease Inhibitors Virus Diseases Anti-Retroviral Agents HIV Infections Sexually Transmitted Diseases Retroviridae Infections |
Antimetabolites Anti-Infective Agents 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 |
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 |