A Study of Indinavir Taken With or Without DMP 266

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).

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

13 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Southern Alberta HIV Clinic / Foot Hills Hosp, Calgary, Alberta, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Indinavir sulfate

Drug

Efavirenz

Drug

Sponsors and collaborators

Lead sponsor

Dupont Merck

Industry

Registry information

Official study title

A Phase III, Double-Blind, Placebo-Controlled, Multicenter Study to Determine the Effectiveness and Tolerability of the Combination of DMP 266 and Indinavir Versus Indinavir in HIV-Infected Patients Receiving Nucleoside Analogue (NRTI) Therapy

Important dates

First posted: Aug 31, 2001
Registry last updated: Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed