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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00004583
First received: November 2, 1999
Last updated: February 19, 2009
Last verified: February 2009
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Lopinavir/Ritonavir
Drug: Nelfinavir mesylate
Drug: Lamivudine
Drug: Stavudine
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Abbott:

Estimated Enrollment: 660
Study Start Date: March 1999
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.

  Eligibility

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

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.
  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: NCT00004583

  Hide Study Locations
Locations
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
AIDS Healthcare Foundation
Los Angeles, California, United States, 900276069
Tower ID Med Associates
Los Angeles, California, United States, 90048
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
Steinhart Medical Associates
Miami, Florida, United States, 33133
Infectious Disease Research Institute
Tampa, Florida, United States, 33614
United States, Georgia
Emory Univ
Atlanta, Georgia, United States, 30308
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States, 30308
United States, Illinois
AIDS Research Alliance - Chicago
Chicago, Illinois, United States, 60657
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
East Orange Veterans Administration Med Ctr
East Orange, New Jersey, United States, 07018
United States, New York
Howard Grossman
New York, New York, United States, 10011
Beth Israel Med Ctr
New York, New York, United States, 10003
Cornell Clinical Trials Unit - Chelsea Clinic
New York, New York, United States, 10011
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, Tennessee
Vanderbilt Univ Med Ctr
Nashville, Tennessee, United States, 37203
United States, Texas
Central Texas Med Foundation
Austin, Texas, United States, 78751
Univ of Texas Southwestern Med Ctr
Dallas, Texas, United States, 75235
Oaklawn Physicians Group
Dallas, Texas, United States, 75219
Joseph C Gathe
Houston, Texas, United States, 77004
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
Royal Perth Hosp
Perth, Australia
Alfred Hosp
Prahan, Australia
Austria
Pulmologisches Zentrum Der Stadt Wien
Wien, Austria
Brazil
Hosp Evandro Chagas Fioernz
Manguinhos RJ, Brazil
Hosp Do Servidor Publico Estadual De Sao Paulo
Sao Paulo, Brazil
Hosp Heliopolis
Sao Paulo, Brazil
Fundacao Zerbini Casa Da Aids
Sao Paulo, Brazil
Castelo
Sao Paulo, Brazil
Canada, British Columbia
Saint Paul's Hosp
Vancouver, British Columbia, Canada
Canada, Ontario
Ottawa General Hospital
Ottawa, Ontario, Canada
Toronto Gen Hosp
Toronto, Ontario, Canada
Canada, Quebec
Montreal Chest Institute
Montreal, Quebec, Canada
Clinique Medicale L'Actuele
Montreal, Quebec, Canada
Clinique Medicale du Quartier Latin
Montreal, Quebec, Canada
Denmark
Righospitalet
Copenhagen, Denmark
Hvidovre Univ Hosp
Hvidovre, Denmark
France
Centre Hospitalier De Compiegne
Compiegne, France
CHU De Bicetre
Paris, France
Groupe Hospitalier Bichat-Claude Bernard
Paris Cedex 18, 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
Poland
Ctr of AIDS Diagnosis and Treatment
Warszawa, Poland
Puerto Rico
Clinical Research Puerto Rico Inc
San Juan, Puerto Rico, 00909
South Africa
Miller
Belford Gardens, South Africa
Cyrildene
Johannesburg, South Africa
Wits Medical School
Parktown, South Africa
Spain
Hosp Germans Trias I Pujol
Barcelona, Spain
Hosp De Mostoles
Madrid, Spain
Hosp La Paz
Madrid, Spain
Hosp Carlos III
Madrid, Spain
Hosp Doce De Octubre
Madrid, Spain
Hosp Virgen Del Rocio
Sevilla, Spain
Switzerland
Universitatsspital Zurich
Zurich, Switzerland
United Kingdom
Brighton Gen Hosp
Brighton, United Kingdom
Royal Free Hosp
London, United Kingdom
Imperial College School of Medicine
London, United Kingdom
Sponsors and Collaborators
Abbott
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00004583     History of Changes
Other Study ID Numbers: 285C, M98-863
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
Administration, Oral
Stavudine
HIV Protease Inhibitors
Lamivudine
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Nelfinavir
ABT 378

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

ClinicalTrials.gov processed this record on September 22, 2014