The Safety and Effectiveness of Indinavir Plus Ritonavir Plus Two NRTIs in HIV-Infected Patients Who Need Early Intervention Treatment

Merck Sharp & Dohme (MSD)

Status and phase: Unknown; Phase 2

Conditions: HIV Infections

Treatments: Drug: Ritonavir; Drug: Indinavir sulfate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00005118

CRX481

246V

107-00

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.