A Comparison of Epivir Plus Crixivan Combined With Zerit or Retrovir in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00002369
First received: November 2, 1999
Last updated: October 1, 2007
Last verified: October 2007
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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: | Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
| 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 |
Criteria
Inclusion Criteria
Patients must have:
- Documented HIV infection.
- CD4 cell count of 200 - 700 cells/mm3.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002369
Locations
| United States, Alabama | |
| Univ of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| United States, Florida | |
| HIV Clinical Research Ctr | |
| Fort Lauderdale, Florida, United States, 33316 | |
| Infectious Disease Research Institute Inc | |
| Tampa, Florida, United States, 33614 | |
| 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 | |
| Boston Univ Med Ctr Hosp / Evans - 556 | |
| Boston, Massachusetts, United States, 02118 | |
| Community Research Initiative of New England | |
| Brookline, Massachusetts, United States, 02445 | |
| 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 | |
Sponsors and Collaborators
Bristol-Myers Squibb
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00002369 History of Changes |
| Other Study ID Numbers: | 260A, BMS 001 |
| Study First Received: | November 2, 1999 |
| Last Updated: | October 1, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Bristol-Myers Squibb:
|
Drug Therapy, Combination Zidovudine Stavudine HIV Protease Inhibitors CD4 Lymphocyte Count |
Lamivudine Indinavir Reverse Transcriptase Inhibitors Anti-HIV Agents Viral Load |
Additional relevant MeSH terms:
|
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 |
Reverse Transcriptase Inhibitors Indinavir Anti-HIV Agents HIV Protease Inhibitors Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Protease Inhibitors |
ClinicalTrials.gov processed this record on June 17, 2013