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| Sponsored by: |
Merck |
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00005118 |
Purpose
The purpose of this study is to see if it is safe and effective to give indinavir plus ritonavir plus 2 NRTIs to HIV-infected patients who need early intervention treatment.
| Condition | Intervention | Phase |
|
HIV Infections |
Drug: Indinavir sulfate Drug: Ritonavir |
Phase II |
| MedlinePlus related topics: | AIDS |
| ChemIDplus related topics: | Indinavir Indinavir Sulfate Nelfinavir Nelfinavir Mesylate Ritonavir |
| Study Type: | Interventional |
| Study Design: | Treatment, Safety Study |
| Official Title: | A Multicenter, Open-Label, 24-Week Study to Evaluate the Efficacy and Safety of Indinavir Sulfate 800 Mg and Ritonavir 200 Mg b.i.d. Plus 2 NRTIs b.i.d. in HIV-1 Infected Individuals Who Require Early Treatment Intervention |
| Estimated Enrollment: | 100 |
Patients receive indinavir bid plus ritonavir bid, plus 2 NRTIs bid (2 new NRTIs or 1 new NRTI and 1 NRTI without evidence of resistance). CD4 cell counts and plasma viral RNA are measured every 4 weeks for the duration of the study. Physical examination and laboratory tests of blood and urine are performed every 4 weeks for the duration of the study. Chest x-ray and 12-lead ECG are done prestudy.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients may be eligible for this study if they:
Contacts and Locations![]() |
Show 40 Study Locations |
| Merck |
More Information
| Study ID Numbers: | 246V, CRX481, 107-00 |
| First Received: | April 7, 2000 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00005118 |
| Health Authority: | United States: Food and Drug Administration |
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