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| Sponsor: | 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 |
| 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 | |
More Information
| Study ID Numbers: | 260B, BMS 002 |
| Study First Received: | November 2, 1999 |
| Last Updated: | October 1, 2007 |
| ClinicalTrials.gov Identifier: | NCT00002168 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Didanosine 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 Didanosine HIV Infections Sexually Transmitted Diseases Lentivirus Infections |
