NCT00005118UnknownPhase 2
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
Merck Sharp & Dohme LLC75 sites in 1 country100 target enrollmentStarted: August 31, 2001Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 100
- Locations
- 75
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Investigators
Study Sites (75)
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