A Multicenter, Open-Label, Randomized, Study to Compare the Efficacy and Safety of Indinavir 800 mg b.i.d. Plus Ritonavir 100 mg b.i.d. Plus Two NRTIs vs. Nelfinavir 1250 mg b.i.d. Plus Two NRTIs in HIV-1 Seropositive Patients Who Have Failed or Are Intolerant to an NNRTI Containing Regimen

Merck Sharp & Dohme LLC0 sites330 target enrollmentJanuary 2001

DrugsMK0639, indinavir sulfate / Duration of Treatment: 48 Weeks Comparator: nelfinavir mesylate / Duration of Treatment: 48 Weeks

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: HIV Infections
Sponsor: Merck Sharp & Dohme LLC
Enrollment: 330
Primary Endpoint: Plasma viral RNA levels will be measured at predetermined time points to determine mean change
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

A study comparing Indinavir plus Ritonavir plus 2 NRTIs vs. Nelfinavir 1250 plus two nucleoside reverse transcriptase inhibitors (NRTIs) in the treatment of HIV positive patients who have not responded to or are intolerant to a non-nucleoside reverse transcriptase inhibitor (NNRTI) containing treatment.

Registry

clinicaltrials.gov

Start Date

January 2001

End Date

May 2003

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Merck Sharp & Dohme LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•At least 18 years of age
•HIV positive
•No active heart disease

Exclusion Criteria

•Pregnant or breast feeding
•Unwilling to use birth control or abstinence to prevent pregnancy
•Received an investigational drug or vaccine within the past 30 days or is planning to receive other investigational study drug/vaccine or interferon while in the study
•Plan to receive NNRTIs while in the study
•Received therapy which lowers body's ability to fight infection within the past 30 days or while in the study
•Alcohol or substance abuse
•Hepatitis