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

Merck Sharp & Dohme LLC330 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

330

Conditions

HIV Infections

Interventions

MK0639, indinavir sulfate / Duration of Treatment: 48 WeeksDRUG

Comparator: nelfinavir mesylate / Duration of Treatment: 48 WeeksDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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