A Study of Indinavir Taken With or Without DMP 266

Dupont Merck300 enrolled

Overview

The purpose of this study is to see if it is safe and effective to add DMP 266 to an anti-HIV treatment program of indinavir and nucleoside reverse transcriptase inhibitors (NRTIs).

In this double-blind, placebo-controlled study, 300 patients are randomized to 1 or 2 reverse transcriptase inhibitors of their choice plus blinded therapy on Arm A or B as follows: Arm A: DMP 266 placebo plus indinavir. Arm B: DMP 266 plus indinavir. After 16 weeks, patients may switch the NRTI portion of their regimen if they meet a treatment failure criterion. After the completion of the 24-week period, patients have the option to continue on open-label DMP 266 and indinavir.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

300

Conditions

HIV Infections

Interventions

Indinavir sulfateDRUG

EfavirenzDRUG

Eligibility

Sex: ALLMin age: 13 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria Patients must have: * CD4+ cell count of at least 50 cells/mm3. * HIV RNA level of at least 10,000 copies/ml by reverse transcriptase polymerase chain reaction (RT-PCR, Amplicor test kit) at screening. * Signed, informed consent from parent or legal guardian for patients less than 18 years of age. Exclusion Criteria Prior Medication: Excluded: * DMP 266. * Other nonnucleoside reverse transcriptase inhibitors. Required: One or two NRTIs (except ZDV and d4T in combination) for a minimum of 8 weeks, within 12 weeks prior to screening.

Locations (12)

Kaiser Foundation Hospital

San Francisco, California, United States

Med College of Georgia

Augusta, Georgia, United States

Chicago Ctr for Clinical Research

Chicago, Illinois, United States

Data from ClinicalTrials.gov

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