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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: | 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.
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 | |
| 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 | |
More Information
| 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 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 |