A Phase III Study Comparing Two Different Anti-HIV Drug Combinations in HIV-Positive Patients Without Previous Anti-HIV Drug Therapy

February 19, 2009 updated by: Abbott

A Randomized, Double-Blind, Phase III Study of ABT-378/Ritonavir Plus Stavudine and Lamivudine vs Nelfinavir Plus Stavudine and Lamivudine in Antiretroviral Naive HIV-Infected Subjects

The purpose of this study is to see how safe a new protease inhibitor (PI) is and how well it fights HIV infection. A PI is a drug that stops HIV from using healthy cells to make more virus. This study will compare the new PI combination of ABT-378 plus ritonavir (RTV) with another PI, nelfinavir (NFV).

Earlier studies suggest ABT-378/RTV will be just as good as and perhaps better than NFV at fighting HIV infection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Based on the accumulated studies to date, it is expected that ABT-378/ritonavir will provide efficacy that is at least as good as (or superior to) nelfinavir when used in combination with reverse transcriptase inhibitors.

Patients are equally randomized to one of two treatment arms. In one arm, approximately 330 patients receive ABT-378/ritonavir plus nelfinavir placebo. In the other arm, approximately 330 patients receive nelfinavir plus ABT-378/ritonavir placebo. In both arms, these protease inhibitors are blinded to the investigator, patient, and sponsor. Both arms receive open-label stavudine and lamivudine. Vital sign measurements, physical examinations, ECGs, routine clinical laboratory evaluations, and determinations of antiviral and immunologic activity are performed at intervals throughout the study.

Study Type

Interventional

Enrollment

660

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
      • Perth, Australia
        • Royal Perth Hosp
      • Prahan, Australia
        • Alfred 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
        • 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
  • France
      • Compiegne, France
        • Centre Hospitalier de Compiegne
      • Paris, France
        • CHU de Bicêtre
      • Paris Cedex 18, France
        • Groupe hospitalier Bichat-Claude Bernard
      • 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
  • Poland
      • Warszawa, Poland
        • Ctr of AIDS Diagnosis and Treatment
  • Puerto Rico
      • San Juan, Puerto Rico, 00909
        • Clinical Research Puerto Rico Inc
  • South Africa
      • Belford Gardens, South Africa
        • Miller
      • Johannesburg, South Africa
        • Cyrildene
      • Parktown, South Africa
        • WITS Medical School
  • 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
        • Royal Free Hosp
      • London, United Kingdom
        • Imperial College School of Medicine
  • United States
    • 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
      • Miami, Florida, United States, 33133
        • Steinhart Medical Associates
      • 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, 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
      • East Orange, New Jersey, United States, 07018
        • East Orange Veterans Administration Med Ctr
    • 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 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
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Vanderbilt Univ Med Ctr
    • Texas
      • Austin, Texas, United States, 78751
        • Central Texas Med Foundation
      • Dallas, Texas, United States, 75235
        • Univ of Texas Southwestern Med Ctr
      • Dallas, Texas, United States, 75219
        • Oaklawn Physicians Group
      • Houston, Texas, United States, 77004
        • Joseph C Gathe
    • 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 (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

You may be eligible for this trial if you:

  • Are HIV positive.
  • Have a viral load (level of HIV in your blood) of more than 400 copies/ml.
  • Are age 12 or older.
  • Agree to practice abstinence or use effective methods of birth control during the study.

Exclusion Criteria

You will not be eligible for this trial if you:

  • Have taken anti-HIV drugs for more than 14 days in the past, or if you have ever taken d4T or 3TC.
  • Are seriously ill or have an AIDS-related infection.
  • Are pregnant or breast-feeding.
  • Are taking certain medications.

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
  • Masking: DOUBLE

Collaborators and Investigators

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

Sponsor

Abbott

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start

March 1, 1999

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

  • 285C
  • M98-863

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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