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| Sponsor: | Bristol-Myers Squibb |
|---|---|
| Information provided by: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00002371 |
Purpose
To compare the magnitude and durability of the reduction in plasma HIV RNA in the two treatment groups over the first 12 weeks of treatment. To determine the safety of each of the two treatment groups.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Indinavir sulfate Drug: Lamivudine Drug: Stavudine Drug: Zidovudine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Randomized Double-Blind Study of Safety, Virologic and Immunological Effects of Stavudine Plus Lamivudine (3TC) Versus Zidovudine Plus Lamivudine in HIV-Infected Subjects Following At Least Six Months of Zidovudine Therapy |
| Estimated Enrollment: | 80 |
| Study Start Date: | June 1996 |
| Study Completion Date: | December 1997 |
| Primary Completion Date: | December 1997 (Final data collection date for primary outcome measure) |
Patients will be randomized to either Stavudine (d4T) + Lamivudine (3TC) + Zidovudine placebo or Zidovudine (ZDV) + Lamivudine + Stavudine placebo. Patients whose plasma HIV RNA levels remain >= 500 copies/ml after 8 weeks of blinded double combination therapy will have indinavir added to their treatment regimen at the week 12 visit.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with any of the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Patients with any of the following prior conditions or symptoms are excluded:
Prior Medication:
Excluded:
Risk Behavior:
Excluded:
Required:
At least 6 months of prior cumulative ZDV therapy.
Contacts and Locations| United States, California | |
| Harbor UCLA Med Ctr | |
| Torrance, California, United States, 90502 | |
| United States, Florida | |
| Univ of South Florida | |
| Tampa, Florida, United States, 33612 | |
| United States, New York | |
| SUNY at Stony Brook / Division of Infectious Diseases | |
| Stony Brook, New York, United States, 11794 | |
| United States, Texas | |
| Houston Clinical Research Network / Div of Montrose Clinic | |
| Houston, Texas, United States, 77006 | |
| United States, Utah | |
| Univ of Utah / School of Medicine / Div of Infect Dis | |
| Salt Lake City, Utah, United States, 84132 | |
| Canada, Ontario | |
| Sunnybrook Health Science Ctr | |
| North York, Ontario, Canada | |
| Canada, Quebec | |
| Montreal Gen Hosp / Div of Clin Immuno and Allergy | |
| Montreal, Quebec, Canada | |
| Puerto Rico | |
| Univ of Puerto Rico School of Medicine | |
| San Juan, Puerto Rico, 00927 | |
| Principal Investigator: | . . | . |
More Information
| ClinicalTrials.gov Identifier: | NCT00002371 History of Changes |
| Other Study ID Numbers: | 244B, AI455-048 |
| Study First Received: | November 2, 1999 |
| Last Updated: | April 28, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
HIV-1 Drug Therapy, Combination Stavudine Lamivudine |
RNA, Viral 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 Zidovudine Stavudine Lamivudine |
Indinavir Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents HIV Protease Inhibitors Protease Inhibitors |