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

February 19, 2009 updated by: Abbott

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

February 20, 2009

Last Update Submitted That Met QC Criteria

February 19, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 285D
  • M98-888

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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