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| Sponsored by: |
Bristol-Myers Squibb |
| Information provided by: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00002168 |
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 |
| MedlinePlus related topics: | AIDS AIDS Medicines |
| ChemIDplus related topics: | Zidovudine Lamivudine Indinavir Indinavir Sulfate Didanosine Stavudine BaseLine |
| Study Type: | Interventional |
| Study Design: | Treatment, Parallel Assignment, Safety Study |
| 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 |
| 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 |
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, California | |||||
| Harbor UCLA Med Ctr / Division of Immunology / N-24 | |||||
| Torrance, California, United States, 90509 | |||||
| East Bay AIDS Clinic | |||||
| Berkeley, California, United States, 94705 | |||||
| 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 | |||||
| Bristol-Myers Squibb |
More Information
BMS Clinical Trials Disclosure
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For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm
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| Study ID Numbers: | 260B, BMS 002 |
| First Received: | November 2, 1999 |
| Last Updated: | October 1, 2007 |
| ClinicalTrials.gov Identifier: | NCT00002168 |
| Health Authority: | United States: Food and Drug Administration |
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