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| Descriptive Information Fields | |
| Brief Title † | A Comparison of Two Anti-HIV Triple-Drug Combinations in HIV-Infected Patients |
| 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 |
| Brief Summary | 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. |
| Detailed Description | 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. |
| Study Phase | |
| Study Type † | Interventional |
| Study Design † | Treatment, Parallel Assignment, Safety Study |
| Primary Outcome Measure † | |
| Secondary Outcome Measure † | |
| Condition † | HIV Infections |
| Intervention † | Drug: Indinavir sulfate Drug: Lamivudine Drug: Stavudine Drug: Zidovudine Drug: Didanosine |
| MEDLINE PMIDs | |
| Links | BMS Clinical Trials Disclosure  For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm |
| Recruitment Information Fields | |
| Recruitment Status † | Completed |
| Enrollment † | 200 |
| Start Date † | |
| Completion Date | |
| Eligibility Criteria † | 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. |
| Gender | Both |
| Ages | 16 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts †† | |
| Location Countries † | United States, Puerto Rico |
| Administrative Information Fields | |
| NCT ID † | NCT00002168 |
| Organization ID | 260B |
| Secondary IDs †† | BMS 002 |
| Study Sponsor † | Bristol-Myers Squibb |
| Collaborators †† | |
| Investigators † | |
| Information Provided By | Bristol-Myers Squibb |
| Verification Date | October 2007 |
| First Received Date † | November 2, 1999 |
| Last Updated Date | October 1, 2007 |
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