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

HIV Infections Clinical Trial

Official title:

A Phase III Study Comparing the Antiviral Efficacy and Safety of Atazanavir With Nelfinavir: Each in Combination With Dual Nucleoside Therapy in HIV-Infected Subjects Who Have Failed a Regimen Not Containing a Protease Inhibitor

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00028067
• Other study ID #: 302F
• Secondary ID: AI424-037
• Status: Terminated
• Phase: Phase 3
• First received: December 10, 2001
• Last updated: April 28, 2011
• Start date: August 2001
• Est. completion date: April 2002

Study information

• Verified date: April 2011
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Terminated
• Enrollment: 500
• Est. completion date: April 2002
• Est. primary completion date: April 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria

Patients may be eligible for this study if they:

• Have a viral load of 1000 or more copies/ml within 3 weeks before randomization. Have a CD4 cell count of 50 or more cells/mm3 within 3 weeks prior to randomization.

• Are at least 16 years old (or the minimum age by local requirements).

• Have had more than 16 weeks of therapy with a non-nucleoside reverse transcriptase inhibitor (NNRTI) and/or nucleoside reverse transcriptase inhibitor (NRTI).

• Use effective barrier method of contraception.

• Give written informed consent.

• Are available for follow-up for at least 52 weeks.

Exclusion Criteria

Patients may not be eligible for this study if they:

• Have used a protease inhibitor (PI) treatment for more than 7 days or within 30 days prior to screening.

• Have a newly-diagnosed HIV-related infection or any medical condition requiring relatively short but intense therapy at the time of enrollment.

• Have hepatitis in the 30 days before the study. Patients with long-term hepatitis are eligible if their liver function meets certain requirements.

• Are unable to demonstrate responsiveness to a provided NRTI.

• Have had previous or expect a need for therapy with agents that may cause damage to nerve tissue, the pancreas, the liver, bone marrow, or cells within 3 months of study start.

• Use too much alcohol or drugs to be able to follow the study therapy; or if they use enough to increase the risk of developing pancreatitis or chemical hepatitis.

• Have severe diarrhea within 30 days prior to study entry.

• Are pregnant or breast-feeding.

• Have a history of hemophilia.

• Have history or signs of bilateral peripheral neuropathy.

• Have cardiomyopathy.

• Have certain heart problems.

• Cannot tolerate oral medication.

• Have any other problems that would interfere with the study.

Study Design

Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Atazanavir

• Nelfinavir mesylate

Locations

Country	Name	City	State
Canada	McMaster Univ Med Ctr	Hamilton	Ontario
Canada	Clinique Medicale du Quartier Latin	Montreal	Quebec
Canada	Clinique Medicale L'Actuele	Montreal	Quebec
Canada	Sunnybrook Health Science Ctr	Toronto	Ontario
Canada	Downtown Infectious Diseases Clinic	Vancouver	British Columbia
Mexico	Hospital General De Mexico	Mexico City
Mexico	Hospital Regional	Mexico City
Mexico	Instituto Nacional de Enfermedades Respiratorias	Mexico City
Mexico	Instituto Nacional de la Nutricion	Mexico City
Puerto Rico	Ponce School of Medicine	Ponce
Puerto Rico	Hepatology / Infectious Diseases	Santruce
Thailand	Program on AIDS / Thai Red Cross Society	Bangkok
Thailand	Ramathibodi Hosp	Bangkok
Thailand	Siriraj Hosp / Mahidol Univ	Bangkok
Thailand	Khonkaen Univ	Khonkaen
United States	Summa Health System	Akron	Ohio
United States	IDC Research Initiative	Altamonte Springs	Florida
United States	Philip Brachman	Atlanta	Georgia
United States	Larry Bush	Atlantis	Florida
United States	Med College of Georgia	Augusta	Georgia
United States	East Bay AIDS Ctr	Berkeley	California
United States	Beth Israel Deaconess Med Ctr	Boston	Massachusetts
United States	Bach and Godofsky	Bradenton	Florida
United States	Albert Einstein College of Medicine	Bronx	New York
United States	Community Research Initiative of New England	Brookline	Massachusetts
United States	Ludwig Lettau Private Practice	Charleston	South Carolina
United States	Carolinas Med Ctr	Charlotte	North Carolina
United States	Cook County Gen Hosp / Division of Infect Diseases	Chicago	Illinois
United States	Univ of South Carolina School of Medicine	Columbia	South Carolina
United States	North Texas Center for AIDS & Clinical Research	Dallas	Texas
United States	Univ of Texas Southwestern Med Ctr	Dallas	Texas
United States	Henry Ford Hosp	Detroit	Michigan
United States	Gary Richmond MD	Fort Lauderdale	Florida
United States	North Broward Hosp District / HIV Clinical Research	Fort Lauderdale	Florida
United States	Orange County Ctr for Special Immunology	Fountain Valley	California
United States	Hampton Roads Med Specialists	Hampton	Virginia
United States	Piedmont Infectious Disease Consultants	Hickory	North Carolina
United States	Joseph Gathe	Houston	Texas
United States	Univ TX Health Science Ctr	Houston	Texas
United States	Jemsek Clinic	Huntersville	North Carolina
United States	Division of Inf Diseases/ Indiana Univ Hosp	Indianapolis	Indiana
United States	Health for Life Clinic	Little Rock	Arkansas
United States	Tower Infectious Diseases	Los Angeles	California
United States	Wisconsin AIDS Research Consortium	Milwaukee	Wisconsin
United States	Tulane Univ School of Medicine	New Orleans	Louisiana
United States	Community Research Initiative on AIDS	New York	New York
United States	Mount Sinai Med Ctr	New York	New York
United States	Saint Luke's - Roosevelt Hosp Ctr	New York	New York
United States	Hahnemann Univ Hosp	Philadelphia	Pennsylvania
United States	Research & Education Group	Portland	Oregon
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	Infectious Diseases Associates	Sarasota	Florida
United States	South Jersey Infectious Diseases Inc	Somers Point	New Jersey
United States	CRI - Springfield	Springfield	Massachusetts
United States	Washington Univ School of Medicine	St Louis	Missouri
United States	Daniel Seekins	Tampa	Florida
United States	Infectious Disease Research Inst	Tampa	Florida
United States	Associates in Med and Mental Health	Tulsa	Oklahoma
United States	Infectious Disease Clinic	Warren	Michigan
United States	Wake Forest Univ School of Medicine	Winston Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Canada,  Mexico,  Puerto Rico,  Thailand, 

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm