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A Comparison of Atazanavir and Nelfinavir, Each in Combination With 2 NRTIs, in Patients Who Have Failed Treatments Without a Protease Inhibitor

Phase 3
Terminated
Conditions
HIV Infections
Registration Number
NCT00028067
Lead Sponsor
Bristol-Myers Squibb
Brief Summary

The purpose of this study is to compare the atazanavir and nelfinavir (NFV) treatments in their ability to reduce viral load.

Detailed Description

In this double-blind, double-placebo, randomized, 2-arm study, atazanavir and NFV each are given in combination with 2 open-label nucleoside reverse transcriptase inhibitors (NRTIs) over 48 weeks. Patients assigned to atazanavir will receive placebo capsules which are identical in size and appearance to NFV. Patients assigned to NFV will receive placebo capsules which are identical in size and appearance to atazanavir. HIV levels are monitored.

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
500
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (62)

Health for Life Clinic

🇺🇸

Little Rock, Arkansas, United States

East Bay AIDS Ctr

🇺🇸

Berkeley, California, United States

Orange County Ctr for Special Immunology

🇺🇸

Fountain Valley, California, United States

Tower Infectious Diseases

🇺🇸

Los Angeles, California, United States

Kaiser Hospital

🇺🇸

Sacramento, California, United States

HIV Institute / Davies Med Ctr

🇺🇸

San Francisco, California, United States

Kaiser Foundation Hospital

🇺🇸

San Francisco, California, United States

IDC Research Initiative

🇺🇸

Altamonte Springs, Florida, United States

Larry Bush

🇺🇸

Atlantis, Florida, United States

Bach and Godofsky

🇺🇸

Bradenton, Florida, United States

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Health for Life Clinic
🇺🇸Little Rock, Arkansas, United States

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