Clinical trial NCT00028067: A Comparison of Atazanavir and Nelfinavir, Each in Combination With 2 NRTIs, in Patients Who Have Failed Treatments Without a Protease Inhibitor
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: HIV Infections
Keywords: Drug Therapy, Combination
HIV Protease Inhibitors
RNA, Viral
Reverse Transcriptase Inhibitors
Viral Load
BMS 232632
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2001-12-11
Enrollment: 500
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

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