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| Sponsor: | Glaxo Wellcome |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002203 |
Purpose
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 |
|---|---|
|
HIV Infections |
Drug: Lamivudine/Zidovudine Drug: Lamivudine Drug: Zidovudine |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Primary Purpose: Treatment |
| 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.
Eligibility| 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.
Contacts and Locations| United States, California | |
| Pacific Oaks Med Ctr | |
| Beverly Hills, California, United States, 90211 | |
| Tower Infectious Diseases / Med Associates Inc | |
| Los Angeles, California, United States, 90048 | |
| 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 | |
More Information
| ClinicalTrials.gov Identifier: | NCT00002203 History of Changes |
| Other Study ID Numbers: | 280A, NZTA4001 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| 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 |
|
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 Protease Inhibitors Zidovudine Lamivudine |
Reverse Transcriptase Inhibitors Lamivudine, zidovudine drug combination Anti-HIV Agents HIV Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites Nucleic Acid Synthesis Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses |