Overview

This trial is active, not recruiting.

Condition hiv infections
Treatments indinavir sulfate, ritonavir
Phase phase 2
Sponsor Merck Sharp & Dohme Corp.
Trial size 100 participants
Trial identifier NCT00005118, 107-00, 246V, CRX481

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Primary purpose treatment

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria Patients may be eligible for this study if they: - Are HIV-positive. - Are 18 years of age or older. - Have a CD4 cell count of at least 50 cells/mm3. - Have a viral load (level of HIV in the blood) of at least 400 copies/ml but no more than 20,000 copies/ml. - Have had an initial response to protease inhibitor therapy with a viral load of less than 400 copies/ml in two consecutive tests at least 1 week apart. - Have been on anti-HIV (antiretroviral) treatment including indinavir or nelfinavir for at least 16 weeks. - Have had virologic failure (two consecutive viral loads that were greater than or equal to 400 copies/ml and less than or equal to 20,000 copies/ml at least 1 week apart) that is not due to another infection, vaccination, or a temporary stop in treatment. - Are naive to at least one of the selected NRTIs.

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2005.
Information provided to ClinicalTrials.gov by NIH AIDS Clinical Trials Information Service.