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A Study to Compare Two Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Previously Received Anti-HIV Treatment

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00004581
First received: November 2, 1999
Last updated: February 19, 2009
Last verified: February 2009
  Purpose

The purpose of this study is to compare the safety and effectiveness of 2 anti-HIV drug combinations in HIV-infected patients. Both combinations will include nevirapine (NVP), 2 nucleoside reverse transcriptase inhibitors (NRTIs), and at least 1 protease inhibitor (PI). One combination will include a new protease inhibitor, ABT-378, combined in a capsule with ritonavir (RTV).


Condition Intervention Phase
HIV Infections
Drug: Lopinavir/Ritonavir
Drug: Nevirapine
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label, Phase III Study of ABT-378/Ritonavir in Combination With Nevirapine and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) vs. Investigator Selected Protease Inhibitor(s) in Combination With Nevirapine and Two NRTIs in Antiretroviral-Experienced HIV-Infected Subjects

Resource links provided by NLM:


Further study details as provided by Abbott:

Estimated Enrollment: 300
Detailed Description:

Patients receive 1 of the following:

  1. ABT-378/RTV plus NVP plus 2 NRTIs; or
  2. Investigator-selected PI(s) plus NVP plus 2 NRTIs.
  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

  • Are at least 12 years old.
  • Are HIV-positive and have a viral load (level of HIV in the blood) of 1,000 - 100,000 copies/ml.
  • Are currently taking an anti-HIV drug combination that includes 1 PI and 2 NRTIs, and that has not been changed in at least 12 weeks.
  • Are naive to (have never taken) at least 1 NRTI, other than zalcitabine or abacavir.
  • Agree to abstinence or use of an effective barrier method (e.g., condom) of birth control.

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Have an active illness.
  • Have received treatment for any active opportunistic (AIDS-related) infection within 30 days of study entry.
  • Have ever received a nonnucleoside reverse transcriptase inhibitor (NNRTI).
  • Have received investigational (not yet approved by the FDA) drugs within 30 days of study entry.
  • Have received treatment with a PI other than their current PI.
  • Are receiving chemotherapy for cancer.
  • Are pregnant or breast-feeding.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004581

  Hide Study Locations
Locations
United States, Alabama
Univ of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Phoenix Body Positive
Phoenix, Arizona, United States, 85016
United States, California
Pacific Oaks Med Group
Beverly Hills, California, United States, 90211
Orange County Ctr for Special Immunology
Fountain Valley, California, United States, 92708
UCLA CARE Ctr
Los Angeles, California, United States, 90095
Tower ID Med Associates
Los Angeles, California, United States, 90048
AIDS Healthcare Foundation
Los Angeles, California, United States, 900276069
San Francisco Veterans Administration Med Ctr
San Francisco, California, United States, 94121
Harbor - UCLA Med Ctr
Torrance, California, United States, 90502
United States, Connecticut
Yale Univ / AIDS Clinical Trials Unit
New Haven, Connecticut, United States, 06510
United States, Florida
Univ of Miami School of Medicine
Miami, Florida, United States, 33136
Infectious Disease Research Institute
Tampa, Florida, United States, 33614
United States, Georgia
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States, 30308
Emory Univ
Atlanta, Georgia, United States, 30308
United States, Illinois
AIDS Research Alliance - Chicago
Chicago, Illinois, United States, 60657
Cook County Hosp
Chicago, Illinois, United States, 60612
United States, Indiana
Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis, Indiana, United States, 46202
United States, Kansas
Univ of Kansas School of Medicine
Wichita, Kansas, United States, 67214
United States, Louisiana
Tulane Univ Med School
New Orleans, Louisiana, United States, 70112
United States, Maryland
Johns Hopkins Hosp
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Boston Med Ctr
Boston, Massachusetts, United States, 02118
Community Research Initiative of New England
Brookline, Massachusetts, United States, 02445
United States, Michigan
Univ of Michigan Hospitals and Health Ctrs
Ann Arbor, Michigan, United States, 481090378
United States, Minnesota
Abbott Northwestern Hosp
Minneapolis, Minnesota, United States, 55407
United States, New Jersey
Saint Michael's Med Ctr / Dept of Infectious Diseases
Newark, New Jersey, United States, 07102
St Michaels Med Ctr
Newark, New Jersey, United States, 07102
United States, New York
Howard Grossman
New York, New York, United States, 10011
Cornell Clinical Trials Unit - Chelsea Clinic
New York, New York, United States, 10011
Beth Israel Med Ctr
New York, New York, United States, 10003
SUNY / Health Sciences Ctr at Stony Brook
Stony Brook, New York, United States, 117948153
SUNY at Stony Brook / Div of Infectious Disease
Stony Brook, New York, United States, 117948153
United States, North Carolina
Duke Univ Med Ctr / Infectious Disease Clinic
Durham, North Carolina, United States, 27710
United States, Ohio
Holmes Hosp / Univ of Cincinnati Med Ctr
Cincinnati, Ohio, United States, 452670405
United States, Oklahoma
Associates in Med and Mental Health
Tulsa, Oklahoma, United States, 74114
United States, Oregon
Oregon Health Sciences Univ
Portland, Oregon, United States, 972109951
United States, Pennsylvania
Philadelphia FIGHT
Philadelphia, Pennsylvania, United States, 19107
Stephen Hauptman
Philadelphia, Pennsylvania, United States, 19107
United States, Rhode Island
The Miriam Hosp
Providence, Rhode Island, United States, 02906
United States, Texas
Oaklawn Physicians Group
Dallas, Texas, United States, 75219
Univ of Texas Southwestern Med Ctr
Dallas, Texas, United States, 75235
Univ of Texas / Med Branch at Galveston
Galveston, Texas, United States, 775550835
Joseph C Gathe
Houston, Texas, United States, 77004
United States, Utah
Univ of Utah Med School / Clinical Trials Ctr
Salt Lake City, Utah, United States, 84108
United States, Virginia
Infectious Disease Physicians Inc
Annandale, Virginia, United States, 22203
Univ of Virginia Health Sciences Ctr
Charlottesville, Virginia, United States, 22908
United States, Wisconsin
Univ of Wisconsin
Madison, Wisconsin, United States, 53792
Australia
Royal Brisbane Hosp
Herston, Australia
Austria
Pulmologisches Zentrum Der Stadt Wien
Wien, Austria
Brazil
Hosp Evandro Chagas Fioernz
Manguinhos RJ, Brazil
Castelo
Sao Paulo, Brazil
Fundacao Zerbini Casa Da Aids
Sao Paulo, Brazil
Hosp Do Servidor Publico Estadual De Sao Paulo
Sao Paulo, Brazil
Hosp Heliopolis
Sao Paulo, Brazil
Canada, British Columbia
Saint Paul's Hosp
Vancouver, British Columbia, Canada
Canada, Ontario
Ottawa General Hospital
Ottawa, Ontario, Canada
Sunnybrook Health Science Ctr
Toronto, Ontario, Canada
Toronto Gen Hosp
Toronto, Ontario, Canada
Canada, Quebec
Clinique Medicale du Quartier Latin
Montreal, Quebec, Canada
Clinique Medicale L'Actuele
Montreal, Quebec, Canada
Montreal Chest Institute
Montreal, Quebec, Canada
Denmark
Righospitalet
Copenhagen, Denmark
Hvidovre Univ Hosp
Hvidovre, Denmark
Odense Univ Hosp
Odense C, Denmark
France
CHU De Bicetre
Paris, France
Groupe Hospitalier Bichat-Claude Bernard
Paris Cedex 18, France
Hopital Gustave Dron
Tourcoing, France
Hopital Paul Brousse
Villejuif, France
Germany
EPIMED
Berlin, Germany
Heinrich Heine Universitat
Dusseldorf, Germany
Klinikum Der Johann Wolfgang Goethe Universitat
Frankfurt, Germany
Allgemeines Krankenhaus St Georg
Hamburg, Germany
Univ Zu Koeln
Koeln, Germany
Aids Study Group Mannheim
Mannheim, Germany
Poland
Ctr of AIDS Diagnosis and Treatment
Warszawa, Poland
Puerto Rico
Ponce Univ Hosp
Ponce, Puerto Rico, 00731
South Africa
Miller
Belford Gardens, South Africa
Cyrildene
Johannesburg, South Africa
Spain
Hosp Germans Trias I Pujol
Barcelona, Spain
Hosp Carlos III
Madrid, Spain
Hosp De Mostoles
Madrid, Spain
Hosp Doce De Octubre
Madrid, Spain
Hosp La Paz
Madrid, Spain
Hosp Virgen Del Rocio
Sevilla, Spain
Switzerland
Universitatsspital Zurich
Zurich, Switzerland
United Kingdom
Brighton Gen Hosp
Brighton, United Kingdom
Chelsea and Westminster Hosp
London, United Kingdom
Imperial College School of Medicine
London, United Kingdom
Royal Free Hosp
London, United Kingdom
Sponsors and Collaborators
Abbott
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00004581     History of Changes
Other Study ID Numbers: 285D, M98-888
Study First Received: November 2, 1999
Last Updated: February 19, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Drug Therapy, Combination
Nevirapine
HIV Protease Inhibitors
Ritonavir
Reverse Transcriptase Inhibitors
Anti-HIV Agents
ABT 378

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
HIV Protease Inhibitors
Lopinavir
Nevirapine
Protease Inhibitors
Reverse Transcriptase Inhibitors
Ritonavir
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014