MedPath

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)

Ramathibodi Hosp

🇹🇭

Bangkok, Thailand

Khonkaen Univ

🇹🇭

Khonkaen, Thailand

Health for Life Clinic

🇺🇸

Little Rock, Arkansas, United States

Downtown Infectious Diseases Clinic

🇨🇦

Vancouver, British Columbia, Canada

Clinique Medicale L'Actuele

🇨🇦

Montreal, Quebec, Canada

South Jersey Infectious Diseases Inc

🇺🇸

Somers Point, New Jersey, United States

Univ of South Carolina School of Medicine

🇺🇸

Columbia, South Carolina, United States

Hospital General De Mexico

🇲🇽

Mexico City, Mexico

Siriraj Hosp / Mahidol Univ

🇹🇭

Bangkok, Thailand

Hepatology / Infectious Diseases

🇵🇷

Santruce, Puerto Rico

Program on AIDS / Thai Red Cross Society

🇹🇭

Bangkok, Thailand

Beth Israel Deaconess Med Ctr

🇺🇸

Boston, Massachusetts, United States

Univ TX Health Science Ctr

🇺🇸

Houston, Texas, United States

East Bay AIDS Ctr

🇺🇸

Berkeley, California, United States

Tower Infectious Diseases

🇺🇸

Los Angeles, California, United States

Bach and Godofsky

🇺🇸

Bradenton, Florida, United States

Gary Richmond MD

🇺🇸

Fort Lauderdale, Florida, United States

Clinique Medicale du Quartier Latin

🇨🇦

Montreal, Quebec, Canada

North Broward Hosp District / HIV Clinical Research

🇺🇸

Fort Lauderdale, Florida, United States

North Texas Center for AIDS & Clinical Research

🇺🇸

Dallas, Texas, United States

Community Research Initiative on AIDS

🇺🇸

New York, New York, United States

Orange County Ctr for Special Immunology

🇺🇸

Fountain Valley, California, United States

Hospital Regional

🇲🇽

Mexico City, Mexico

Cook County Gen Hosp / Division of Infect Diseases

🇺🇸

Chicago, Illinois, United States

Joseph Gathe

🇺🇸

Houston, Texas, United States

CRI - Springfield

🇺🇸

Springfield, Massachusetts, United States

Carolinas Med Ctr

🇺🇸

Charlotte, North Carolina, United States

Philip Brachman

🇺🇸

Atlanta, Georgia, United States

Univ of Texas Southwestern Med Ctr

🇺🇸

Dallas, Texas, United States

Infectious Diseases Associates

🇺🇸

Sarasota, Florida, United States

Community Research Initiative of New England

🇺🇸

Brookline, Massachusetts, United States

Infectious Disease Clinic

🇺🇸

Warren, Michigan, United States

Associates in Med and Mental Health

🇺🇸

Tulsa, Oklahoma, United States

Med College of Georgia

🇺🇸

Augusta, Georgia, United States

Saint Luke's - Roosevelt Hosp Ctr

🇺🇸

New York, New York, United States

Mount Sinai Med Ctr

🇺🇸

New York, New York, United States

Wake Forest Univ School of Medicine

🇺🇸

Winston Salem, North Carolina, United States

McMaster Univ Med Ctr

🇨🇦

Hamilton, Ontario, Canada

Hahnemann Univ Hosp

🇺🇸

Philadelphia, Pennsylvania, United States

Sunnybrook Health Science Ctr

🇨🇦

Toronto, Ontario, Canada

Division of Inf Diseases/ Indiana Univ Hosp

🇺🇸

Indianapolis, Indiana, United States

Kaiser Foundation Hospital

🇺🇸

San Francisco, California, United States

Henry Ford Hosp

🇺🇸

Detroit, Michigan, United States

HIV Institute / Davies Med Ctr

🇺🇸

San Francisco, California, United States

Research & Education Group

🇺🇸

Portland, Oregon, United States

Daniel Seekins

🇺🇸

Tampa, Florida, United States

Infectious Disease Research Inst

🇺🇸

Tampa, Florida, United States

Wisconsin AIDS Research Consortium

🇺🇸

Milwaukee, Wisconsin, United States

IDC Research Initiative

🇺🇸

Altamonte Springs, Florida, United States

Washington Univ School of Medicine

🇺🇸

St Louis, Missouri, United States

Larry Bush

🇺🇸

Atlantis, Florida, United States

Piedmont Infectious Disease Consultants

🇺🇸

Hickory, North Carolina, United States

Ponce School of Medicine

🇵🇷

Ponce, Puerto Rico

Instituto Nacional de Enfermedades Respiratorias

🇲🇽

Mexico City, Mexico

Instituto Nacional de la Nutricion

🇲🇽

Mexico City, Mexico

Summa Health System

🇺🇸

Akron, Ohio, United States

Jemsek Clinic

🇺🇸

Huntersville, North Carolina, United States

Hampton Roads Med Specialists

🇺🇸

Hampton, Virginia, United States

Kaiser Hospital

🇺🇸

Sacramento, California, United States

Tulane Univ School of Medicine

🇺🇸

New Orleans, Louisiana, United States

Albert Einstein College of Medicine

🇺🇸

Bronx, New York, United States

Ludwig Lettau Private Practice

🇺🇸

Charleston, South Carolina, United States

© Copyright 2025. All Rights Reserved by MedPath