A Study of Indinavir Plus Ritonavir Plus Two NRTIs vs. Nelfinavir Plus Two NRTIs in HIV Positive Patients (0639-112)(COMPLETED)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: HIV Infections

Treatments: Drug: MK0639, indinavir sulfate / Duration of Treatment: 48 Weeks; Drug: Comparator: nelfinavir mesylate / Duration of Treatment: 48 Weeks

Study type: Interventional

Funder types: Industry

Identifiers

NCT00541463

0639-112

2007_642

Details and patient eligibility

About

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.

Enrollment: 330 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)