Atazanavir Versus Lopinavir/Ritonavir (LPV/RTV) in Patients Who Have Not Had Success With Protease Inhibitor-Containing HAART Regimen(s)

HIV Infections Clinical Trial

Official title:

A Randomized Open-label Study of the Antiviral Efficacy and Safety of Atazanavir Versus Lopinavir/Ritonavir(LPV/RTV), Each in Combination With Two Nucleosides in Subjects Who Have Experienced Virologic Failure With Prior Protease Inhibitor-Containing HAART Regimen(s)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00028301
• Other study ID #: 302D
• Secondary ID: AI424-043
• Status: Completed
• Phase: Phase 3
• First received: December 20, 2001
• Last updated: September 10, 2010
• Start date: February 2001
• Est. completion date: September 2003

Study information

• Verified date: September 2010
• 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

This study will compare 2 treatments in the way they affect cholesterol levels and the amount of HIV in the blood.

Description:

The study is designed to determine the metabolic changes, antiviral activity, safety, and tolerability of atazanavir as compared to LPV/RTV, each in combination with 2 nucleosides, over the initial 24 weeks, with a final analysis at 48 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: September 2003
• Est. primary completion date: September 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria

Patients may be eligible for this study if they:

• Are receiving a PI-containing highly active antiretroviral therapy (HAART) for at least 12 weeks.

• Have a viral load of 1,000 or more copies/ml within 4 weeks of screening and within 4 weeks prior to randomization.

• Have 2 CD4 cell counts of 50 or more cells/mm3 at least 96 hours apart and within 4 weeks before randomization.

• Are at least 16 years old.

• Have a documented virologic response to at least 1 HAART regimen.

• Have phenotypic sensitivity to at least 2 of the following: ddl, d4T, ZDV, 3TC, ABC.

• Have phenotypic sensitivity to atazanavir and LPV/RTV.

• Use effective barrier methods of birth control.

• Will be available for 48 weeks.

Exclusion Criteria

Patients will not be eligible for this study if they:

• Have taken 2 or more PIs and had virologic failure.

• Have taken atazanavir or LPV/RTV.

• Have an HIV-related infection (within 30 days) or any medical condition requiring treatment at the time of enrollment.

• Have had acute hepatitis in the 30 days prior to study entry.

• Have received certain drugs within 3 months of study start or expect to need them at time of enrollment.

• Abuse alcohol or drugs in a way that would interfere with the study.

• Have very bad diarrhea within 30 days prior to study entry.

• Are pregnant or breast-feeding.

• Have a history of hemophilia.

• Use lipid-lowering drugs (within the previous 30 days).

• Have cardiomyopathy or symptoms of other heart disease.

• Cannot take medicine by mouth.

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

• Have pancreatitis, if choosing ddI as part of NRTI pair.

• Have bilateral peripheral neuropathy at time of screening, if choosing ddI or or d4T as part of the NRTI pair.

Study Design

Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Atazanavir

• Lopinavir/Ritonavir

Locations

Country	Name	City	State
Argentina	Claudia Rodriguez MD	Buenos Aires
Argentina	Elida Pallone MD	Buenos Aires
Argentina	Fundacion Huesped	Buenos Aires
Argentina	Hospital Italiano	Buenos Aires
Argentina	CAICI	Rosario Santa Fe
Australia	Alfred Hosp	Prahan
Australia	Prahran Market Clinic	South Yarra
Australia	Saint Vincent's Hosp Med Centre	Sydney
Australia	Taylors Square Clinic	Sydney
Belgium	Inst of Tropical Medicine	Antwerpe
Belgium	CHU Saint Pierre	Brussels
Belgium	Cliniques Universitaires Saint Luc	Bruxelles
Belgium	University Hospital Gent	Gent
Belgium	Domaine Universitaire Du SART-TILMAN	Liege
Brazil	Hospital de Clinicas da Universidade Federal do Parana	Curitiba
Brazil	Hospital Nossa Senhora da Conceicao-GCH	Porto Alegre
Brazil	Instituto de Infectologia Emilio Ribas	Sao Paulo
Canada	Clinique Medicale du Quartier Latin	Montreal	Quebec
Canada	Dr Roger P Leblanc	Montreal	Quebec
Canada	Montreal Gen Hosp / Div of Clin Immuno and Allergy	Montreal	Quebec
Canada	Toronto Hosp	Toronto	Ontario
Chile	Fundacion Arriaran	Santiago
Chile	Hosp Sotero de Rio	Santiago
Finland	Aurora Hospital	Unknown
France	Hopital Hotel Dieu de Lyon	Lyon
France	CHU De Bicetre	Paris
France	Hopital Cochin - Port Royal	Paris
France	Services des Maladies Infectieuses	Paris Cedex 12
France	Hopital Gustave Dron	Tourcoing
Italy	Ospedale S Orsola	Bologna
Italy	Immunoligia Universita Cagliari	Cagliari
Italy	Reparto di Malattie Infettive	Corso Svizzera
Italy	Ospedale Luigi Sacco Cargnel	Milano
Italy	Ospedale S Raffaele	Milano
Italy	Ospedale degli Infermi	Rimini
Italy	Cat All Immun Clin	Roma
Italy	Ospedale Amedeo de Savoia	Torino
Italy	Ospedale Amedeo di Savoia	Torino
Mexico	Hospital 1 ro de Octubre	Mexico City
Mexico	Hospital General	Mexico City
Mexico	Hospital Regional	Mexico City
Mexico	Instituto Nacional de la Nutricion	Mexico City
Netherlands	Univ Medical Center Utrecht	CX Utrecht
Peru	Hosp Guillermo Almenara-Medicina 1	Lima
Peru	Hosp Nacional Cayetano Heredia	Lima
Poland	Klinicka Chorobzkaznych AM	Unknown
Puerto Rico	San Cristobal Hosp	Coto Laurel, Ponce
Puerto Rico	Clinical Research Puerto Rico Inc	San Juan
Spain	Hosp Clinic	Barcelona
Spain	Hospital Germans Trias I Pujol	Barcelona
Spain	Hosp de Basurto / Enfermedades Infecciosas	Bilboa
Spain	Hosp Reina Sofia	Cordoba
Spain	Hosp Carlos III	Madrid
Spain	Hosp Ramon y Cajal	Madris
Spain	Hosp Nuestra Senora de Covadonga	Oviedo
Spain	Hosp Virgen Del Rocio	Sevilla
United Kingdom	Whittal Street Clinic	Birmingham
United Kingdom	Royal Liverpool Univ Hosp	Liverpool
United Kingdom	Department of Infection & Tropical Medicine	Unknown
United States	Albany Med College	Albany	New York
United States	IDC Research Initiative	Altamonte Springs	Florida
United States	Larry Bush	Atlantis	Florida
United States	East Bay AIDS Ctr	Berkeley	California
United States	Cooper Green Hosp	Birmingham	Alabama
United States	Sky Blue	Boise	Idaho
United States	Beacon Clinic / Boulder Community Hosp	Boulder	Colorado
United States	Community Research Initiative	Brookline	Massachusetts
United States	Erie County Med Ctr	Buffalo	New York
United States	Univ of South Carolina School of Medicine	Columbia	South Carolina
United States	Nicholas Bellos	Dallas	Texas
United States	North Texas Center for AIDS & Clinical Research	Dallas	Texas
United States	Infectious Disease Specialists of Atlanta	Decatur	Georgia
United States	VAMC New Jersey Healthcare System	East Orange	New Jersey
United States	Community Health Care	Fort Lauderdale	Florida
United States	Univ of Hawaii	Honolulu	Hawaii
United States	Houston Clinical Research Network	Houston	Texas
United States	Infectious Diseases Associates of Houston	Houston	Texas
United States	Jemsek Clinic	Huntersville	North Carolina
United States	Infectious Disease of Indiana	Indianapolis	Indiana
United States	Univ of Kentucky Med Ctr	Lexington	Kentucky
United States	North Shore Univ Hosp	Manhasset	New York
United States	South Beach Medical Associates	Miami Beach	Florida
United States	North Jersey Community Research Initiative	Newark	New Jersey
United States	Florida ID Group	Orlando	Florida
United States	Mark Watkins	Philadelphia	Pennsylvania
United States	Phoenix Body Positive	Phoenix	Arizona
United States	Oregon Health Sciences Univ	Portland	Oregon
United States	Research & Education Group	Portland	Oregon
United States	Steven Zell	Reno	Nevada
United States	Community Health Network	Rochester	New York
United States	Kaiser Foundation Hospital	San Francisco	California
United States	Saint Francis Mem Hosp / HIV Care Unit	San Francisco	California
United States	San Francisco Veterans Administration Med Ctr	San Francisco	California
United States	Southampton Healthcare Inc	St Louis	Missouri
United States	Harbor UCLA Med Ctr	Torrance	California
United States	Univ of Kansas School of Medicine	Wichita	Kansas
United States	Univ of Massachusetts	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Canada,  Chile,  Finland,  France,  Italy,  Mexico,  Netherlands,  Peru,  Poland,  Puerto Rico,  Spain,  United Kingdom, 

External Links

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