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| Sponsor: | Bristol-Myers Squibb |
|---|---|
| Information provided by: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00002369 |
Purpose
To evaluate the tolerance, and comparative virologic and immunologic effects of the two combination regimens.
| Condition | Intervention |
|---|---|
|
HIV Infections |
Drug: Indinavir sulfate Drug: Lamivudine Drug: Stavudine Drug: Zidovudine |
| Study Type: | Interventional |
| Study Design: | Treatment, Parallel Assignment, Safety Study |
| Official Title: | An Open Label, Randomized, Comparative Study of Zerit (d4T) + Epivir (3TC) + Crixivan Versus Retrovir (AZT) + Epivir (3TC) + Crixivan in HIV-Infected, Antiretroviral Naive Subjects With CD4 Cell Counts of 200 - 700 Cells/mm3 and HIV RNA Baseline Copy Number of >= 10,000 Copies/ml |
| Estimated Enrollment: | 200 |
100 patients will be randomized to receive Zerit (Stavudine) + Epivir (Lamivudine) + Crixivan (Indinavir) and 100 patients will be randomized to receive Retrovir (Zidovudine) + Epivir (Lamivudine) + Crixivan (Indinavir).
Patients will be treated for 48 weeks.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
AIDS defining condition within 1 month of study entry.
Prior Medication:
Excluded:
Patients with any history of antiretroviral therapy treatment.
Contacts and Locations| United States, Alabama | |
| Univ of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| United States, Florida | |
| Infectious Disease Research Institute Inc | |
| Tampa, Florida, United States, 33614 | |
| HIV Clinical Research Ctr | |
| Fort Lauderdale, Florida, United States, 33316 | |
| United States, Georgia | |
| Advance Clinical Research | |
| Atlanta, Georgia, United States, 30327 | |
| United States, Louisiana | |
| Louisiana State Univ Med Ctr / HIV Outpatient Clinic | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Massachusetts | |
| Community Research Initiative of New England | |
| Brookline, Massachusetts, United States, 02445 | |
| Boston Univ Med Ctr Hosp / Evans - 556 | |
| Boston, Massachusetts, United States, 02118 | |
| United States, Missouri | |
| Washington Univ School of Medicine | |
| St Louis, Missouri, United States, 63108 | |
| United States, Texas | |
| Blackstock Family Health Ctr | |
| Austin, Texas, United States, 76751 | |
| Puerto Rico | |
| Hosp Regional de Ponce - Area Vieja | |
| Ponce, Puerto Rico, 00731 | |
| San Juan AIDS Program | |
| Santurce, Puerto Rico, 00908 | |
More Information
| Study ID Numbers: | 260A, BMS 001 |
| Study First Received: | November 2, 1999 |
| Last Updated: | October 1, 2007 |
| ClinicalTrials.gov Identifier: | NCT00002369 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Drug Therapy, Combination Zidovudine Stavudine HIV Protease Inhibitors CD4 Lymphocyte Count |
Lamivudine Indinavir Reverse Transcriptase Inhibitors Anti-HIV Agents Viral Load |
|
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Stavudine Indinavir Molecular Mechanisms of Pharmacological Action Zidovudine Lamivudine Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses 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 |
