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

Phase 2

Completed

• Conditions: HIV Infections

• Registration Number: NCT00541463
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2001-01
• Study Completion: 2003-05
• Study First Submitted: 2007-10-09
• Study First Submitted QC: 2007-10-09
• Study First Posted: 2007-10-10
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-16
• Last Update Posted: 2017-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Plasma viral RNA levels will be measured at predetermined time points to determine mean change

Secondary Outcome Measures

Name	Time	Method
CD4 cell counts will be measured at predetermined time points to determine change from baseline