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

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)

Sponsors

Lead Sponsor: Bristol-Myers Squibb

Source Bristol-Myers Squibb
Brief Summary

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

Detailed 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.

Overall Status Completed
Start Date February 2001
Completion Date September 2003
Primary Completion Date September 2003
Phase Phase 3
Study Type Interventional
Condition
Intervention

Intervention Type: Drug

Intervention Name: Atazanavir

Intervention Type: Drug

Intervention Name: Lopinavir/Ritonavir

Eligibility

Criteria:

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.

Gender: All

Minimum Age: 16 Years

Maximum Age: N/A

Healthy Volunteers: No

Location
Facility:
Cooper Green Hosp | Birmingham, Alabama, 35233, United States
Phoenix Body Positive | Phoenix, Arizona, 85006, United States
East Bay AIDS Ctr | Berkeley, California, 94705, United States
Saint Francis Mem Hosp / HIV Care Unit | San Francisco, California, 94109, United States
Kaiser Foundation Hospital | San Francisco, California, 94118, United States
San Francisco Veterans Administration Med Ctr | San Francisco, California, 94121, United States
Harbor UCLA Med Ctr | Torrance, California, 90502, United States
Beacon Clinic / Boulder Community Hosp | Boulder, Colorado, 80304, United States
IDC Research Initiative | Altamonte Springs, Florida, 32701, United States
Larry Bush | Atlantis, Florida, 33462, United States
Community Health Care | Fort Lauderdale, Florida, 33306, United States
South Beach Medical Associates | Miami Beach, Florida, 33160, United States
Florida ID Group | Orlando, Florida, 32801, United States
Infectious Disease Specialists of Atlanta | Decatur, Georgia, 30033, United States
Univ of Hawaii | Honolulu, Hawaii, 96816, United States
Sky Blue | Boise, Idaho, 83704, United States
Infectious Disease of Indiana | Indianapolis, Indiana, 46218, United States
Univ of Kansas School of Medicine | Wichita, Kansas, 672143124, United States
Univ of Kentucky Med Ctr | Lexington, Kentucky, 40536, United States
Community Research Initiative | Brookline, Massachusetts, 02445, United States
Univ of Massachusetts | Worcester, Massachusetts, 01655, United States
Southampton Healthcare Inc | St Louis, Missouri, 63139, United States
Steven Zell | Reno, Nevada, 89502, United States
VAMC New Jersey Healthcare System | East Orange, New Jersey, 07018, United States
North Jersey Community Research Initiative | Newark, New Jersey, 071032842, United States
Albany Med College | Albany, New York, 12208, United States
Erie County Med Ctr | Buffalo, New York, 14215, United States
North Shore Univ Hosp | Manhasset, New York, 11030, United States
Community Health Network | Rochester, New York, 14620, United States
Jemsek Clinic | Huntersville, North Carolina, 28078, United States
Oregon Health Sciences Univ | Portland, Oregon, 97201, United States
Research & Education Group | Portland, Oregon, 97209, United States
Mark Watkins | Philadelphia, Pennsylvania, 19107, United States
Univ of South Carolina School of Medicine | Columbia, South Carolina, 29203, United States
North Texas Center for AIDS & Clinical Research | Dallas, Texas, 75208, United States
Nicholas Bellos | Dallas, Texas, 75246, United States
Houston Clinical Research Network | Houston, Texas, 77006, United States
Infectious Diseases Associates of Houston | Houston, Texas, 77030, United States
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, Argentina
Alfred Hosp | Prahan, Australia
Prahran Market Clinic | South Yarra, Australia
Saint Vincent's Hosp Med Centre | Sydney, Australia
Taylors Square Clinic | Sydney, Australia
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, Belgium
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, Brazil
Toronto Hosp | Toronto, Ontario, 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
Fundacion Arriaran | Santiago, Chile
Hosp Sotero de Rio | Santiago, Chile
Hopital Hotel Dieu de Lyon | Lyon, France
Services des Maladies Infectieuses | Paris Cedex 12, France
CHU De Bicetre | Paris, France
Hopital Cochin - Port Royal | Paris, France
Hopital Gustave Dron | Tourcoing, France
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, Italy
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, Mexico
Univ Medical Center Utrecht | CX Utrecht, Netherlands
Hosp Guillermo Almenara-Medicina 1 | Lima, Peru
Hosp Nacional Cayetano Heredia | Lima, Peru
San Cristobal Hosp | Coto Laurel, Ponce, 00780, Puerto Rico
Clinical Research Puerto Rico Inc | San Juan, 009091711, Puerto Rico
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, Spain
Whittal Street Clinic | Birmingham, United Kingdom
Royal Liverpool Univ Hosp | Liverpool, United Kingdom
Aurora Hospital
Department of Infection & Tropical Medicine
Klinicka Chorobzkaznych AM
Location Countries

Argentina

Australia

Belgium

Brazil

Canada

Chile

France

Italy

Mexico

Netherlands

Peru

Puerto Rico

Spain

United Kingdom

United States

Verification Date

September 2010

Keywords
Condition Browse
Study Design Info

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov