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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Study Completion Date

2003-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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MK0639, indinavir sulfate / Duration of Treatment: 48 Weeks

Intervention Type DRUG

Comparator: nelfinavir mesylate / Duration of Treatment: 48 Weeks

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No