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| Sponsored by: |
Merck |
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002430 |
Purpose
The purpose of this study is to compare two different anti-HIV drug combinations, one that contains nelfinavir (NFV) and one that does not. The best dosing schedule for indinavir (IDV) also will be studied.
| Condition | Intervention |
|
HIV Infections |
Drug: Indinavir sulfate Drug: Nelfinavir mesylate Drug: Lamivudine Drug: Stavudine |
| MedlinePlus related topics: | AIDS AIDS Medicines |
| Drug Information available for: | Lamivudine Indinavir Indinavir Sulfate Stavudine Nelfinavir Nelfinavir Mesylate |
| Study Type: | Interventional |
| Study Design: | Treatment, Safety Study |
| Official Title: | A Multicenter, Open-Label, 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate/d4T/3TC Versus Indinavir Sulfate/Nelfinavir Mesylate/d4T/3TC in HIV-Infected Individuals |
| Estimated Enrollment: | 220 |
Patients are stratified by screening plasma viral RNA results (50,000 copies/ml or below vs above 50,000 copies/ml) and randomized to 1 of 2 treatment arms. Group 1 receives IDV 3 times daily plus d4T/3TC twice daily. Group 2 receives IDV/NFV/d4T/3TC twice daily. Patients remain on study medications for 24 weeks and are seen at the clinic once every 4 weeks after entering the study. At each clinic visit, blood samples are taken to evaluate CD4 cell count and plasma HIV RNA levels.
Eligibility
| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
You may be eligible for this study if you:
Exclusion Criteria
You will not be eligible for this study if you:
Contacts and Locations![]() |
Show 46 Study Locations |
| Merck |
More Information
| Study ID Numbers: | 246R, 079-02, CRX454 |
| First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002430 |
| Health Authority: | United States: Food and Drug Administration |
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