A Comparison of Two Anti-HIV Triple-Drug Combinations in HIV-Infected Patients
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00002168
First received: November 2, 1999
Last updated: October 1, 2007
Last verified: October 2007
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Purpose
The purpose of this study is to compare the safety and effectiveness of two anti-HIV drug combinations when given to HIV-infected patients who have never been treated with anti-HIV drugs. One drug combination is stavudine (d4T) plus didanosine (ddI) plus Crixivan. The other combination is Retrovir (AZT) plus Epivir (3TC) plus Crixivan.
| Condition | Intervention |
|---|---|
|
HIV Infections |
Drug: Indinavir sulfate Drug: Lamivudine Drug: Stavudine Drug: Zidovudine Drug: Didanosine |
| 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) + Videx (ddI) + Crixivan Versus Retrovir (AZT) + Epivir (3TC) + Crixivan in HIV-Infected, Antiretroviral Naive Subjects With CD4 Cell Counts of 200 - 700/mm3 and HIV RNA Baseline Copy Number of >= 10,000 Copies/ml |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
Drug Information available for:
Stavudine
Zidovudine
Didanosine
Lamivudine
Indinavir
Indinavir Sulfate
U.S. FDA Resources
Further study details as provided by Bristol-Myers Squibb:
| Estimated Enrollment: | 200 |
100 patients will be randomized to receive Zerit (Stavudine) + Videx (Didanosine) + 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: NCT00002168
Locations
| United States, California | |
| East Bay AIDS Clinic | |
| Berkeley, California, United States, 94705 | |
| Harbor UCLA Med Ctr / Division of Immunology / N-24 | |
| Torrance, California, United States, 90509 | |
| United States, District of Columbia | |
| George Washington Med Ctr / Clinical Trials Unit | |
| Washington, District of Columbia, United States, 20037 | |
| Anderson Clinical Research | |
| Washington, District of Columbia, United States, 20037 | |
| United States, Illinois | |
| Northwestern Univ | |
| Chicago, Illinois, United States, 60611 | |
| Chicago Ctr for Clinical Research | |
| Chicago, Illinois, United States, 60610 | |
| United States, Nebraska | |
| Univ of Nebraska | |
| Omaha, Nebraska, United States, 68195 | |
| United States, North Carolina | |
| Univ of North Carolina / Infectious Disease Division | |
| Chapel Hill, North Carolina, United States, 27599 | |
| The Nalle Clinic / Clinical Research Dept | |
| Charlotte, North Carolina, United States, 28207 | |
| United States, Pennsylvania | |
| Univ of Pennsylvania / Infectious Diseases Division | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Texas | |
| Southwest Infectious Disease Association / PA | |
| Dallas, Texas, United States, 75225 | |
| Univ of Texas Southwestern Med Ctr of Dallas | |
| Dallas, Texas, United States, 75235 | |
| Puerto Rico | |
| Hosp Regional de Ponce - Area Vieja | |
| Ponce, Puerto Rico, 00731 | |
Sponsors and Collaborators
Bristol-Myers Squibb
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00002168 History of Changes |
| Other Study ID Numbers: | 260B, BMS 002 |
| 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:
|
Didanosine 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 Didanosine Zidovudine Stavudine Lamivudine |
Reverse Transcriptase Inhibitors Indinavir 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 Anti-HIV Agents Protease Inhibitors |
ClinicalTrials.gov processed this record on March 14, 2013
