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

Condition(s) targeted: HIV Infections

Intervention: Lopinavir/Ritonavir (Drug); Nelfinavir mesylate (Drug); Lamivudine (Drug); Stavudine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Abbott

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.

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

Study design: Treatment, Double-Blind, Efficacy Study

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.

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

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.

Alfred Hosp, Prahan, Australia

Royal Brisbane Hosp, Herston, Australia

Royal Perth Hosp, Perth, Australia

Pulmologisches Zentrum Der Stadt Wien, Wien, Austria

Castelo, Sao Paulo, 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

Righospitalet, Copenhagen, Denmark

Hvidovre Univ Hosp, Hvidovre, Denmark

Groupe Hospitalier Bichat-Claude Bernard, Paris Cedex 18, France

CHU De Bicetre, Paris, France

Centre Hospitalier De Compiegne, Compiegne, France

Hopital Paul Brousse, Villejuif, France

Allgemeines Krankenhaus St Georg, Hamburg, Germany

Heinrich Heine Universitat, Dusseldorf, Germany

EPIMED, Berlin, Germany

Univ Zu Koeln, Koeln, Germany

Klinikum Der Johann Wolfgang Goethe Universitat, Frankfurt, Germany

Ctr of AIDS Diagnosis and Treatment, Warszawa, Poland

Clinical Research Puerto Rico Inc, San Juan 00909, Puerto Rico

Cyrildene, Johannesburg, South Africa

Miller, Belford Gardens, South Africa

Wits Medical School, Parktown, South Africa

Hosp La Paz, Madrid, Spain

Hosp De Mostoles, Madrid, Spain

Hosp Germans Trias I Pujol, Barcelona, Spain

Hosp Carlos III, Madrid, Spain

Hosp Doce De Octubre, Madrid, Spain

Hosp Virgen Del Rocio, Sevilla, Spain

Universitatsspital Zurich, Zurich, Switzerland

Royal Free Hosp, London, United Kingdom

Brighton Gen Hosp, Brighton, United Kingdom

Imperial College School of Medicine, London, United Kingdom

Saint Paul's Hosp, Vancouver, British Columbia, Canada

UCLA CARE Ctr, Los Angeles, California 90095, United States

San Francisco Veterans Administration Med Ctr, San Francisco, California 94121, United States

Pacific Oaks Med Group, Beverly Hills, California 90211, United States

Harbor - UCLA Med Ctr, Torrance, California 90502, United States

Tower ID Med Associates, Los Angeles, California 90048, United States

AIDS Healthcare Foundation, Los Angeles, California 900276069, United States

Orange County Ctr for Special Immunology, Fountain Valley, California 92708, United States

Yale Univ / AIDS Clinical Trials Unit, New Haven, Connecticut 06510, United States

Steinhart Medical Associates, Miami, Florida 33133, United States

Univ of Miami School of Medicine, Miami, Florida 33136, United States

Infectious Disease Research Institute, Tampa, Florida 33614, United States

Emory Univ, Atlanta, Georgia 30308, United States

AIDS Research Consortium of Atlanta, Atlanta, Georgia 30308, United States

AIDS Research Alliance - Chicago, Chicago, Illinois 60657, United States

Division of Inf Diseases/ Indiana Univ Hosp, Indianapolis, Indiana 46202, United States

Univ of Kansas School of Medicine, Wichita, Kansas 67214, United States

Tulane Univ Med School, New Orleans, Louisiana 70112, United States

Johns Hopkins Hosp, Baltimore, Maryland 21205, United States

Boston Med Ctr, Boston, Massachusetts 02118, United States

Community Research Initiative of New England, Brookline, Massachusetts 02445, United States

Univ of Michigan Hospitals and Health Ctrs, Ann Arbor, Michigan 481090378, United States

Abbott Northwestern Hosp, Minneapolis, Minnesota 55407, United States

East Orange Veterans Administration Med Ctr, East Orange, New Jersey 07018, United States

Howard Grossman, New York, New York 10011, United States

SUNY at Stony Brook / Div of Infectious Disease, Stony Brook, New York 117948153, United States

Cornell Clinical Trials Unit - Chelsea Clinic, New York, New York 10011, United States

Beth Israel Med Ctr, New York, New York 10003, United States

Duke Univ Med Ctr / Infectious Disease Clinic, Durham, North Carolina 27710, United States

Holmes Hosp / Univ of Cincinnati Med Ctr, Cincinnati, Ohio 452670405, United States

Associates in Med and Mental Health, Tulsa, Oklahoma 74114, United States

Ottawa General Hospital, Ottawa, Ontario, Canada

Toronto Gen Hosp, Toronto, Ontario, Canada

Oregon Health Sciences Univ, Portland, Oregon 972109951, United States

Philadelphia FIGHT, Philadelphia, Pennsylvania 19107, United States

Stephen Hauptman, Philadelphia, Pennsylvania 19107, United States

Montreal Chest Institute, Montreal, Quebec, Canada

Clinique Medicale L'Actuele, Montreal, Quebec, Canada

Clinique Medicale du Quartier Latin, Montreal, Quebec, Canada

The Miriam Hosp, Providence, Rhode Island 02906, United States

Vanderbilt Univ Med Ctr, Nashville, Tennessee 37203, United States

Univ of Texas Southwestern Med Ctr, Dallas, Texas 75235, United States

Central Texas Med Foundation, Austin, Texas 78751, United States

Oaklawn Physicians Group, Dallas, Texas 75219, United States

Joseph C Gathe, Houston, Texas 77004, United States

Infectious Disease Physicians Inc, Annandale, Virginia 22203, United States

Univ of Virginia Health Sciences Ctr, Charlottesville, Virginia 22908, United States

Univ of Wisconsin, Madison, Wisconsin 53792, United States

Related publications:

Murphy RL, Brun S, Hicks C, Eron JJ, Gulick R, King M, White AC Jr, Benson C, Thompson M, Kessler HA, Hammer S, Bertz R, Hsu A, Japour A, Sun E. ABT-378/ritonavir plus stavudine and lamivudine for the treatment of antiretroviral-naive adults with HIV-1 infection: 48-week results. AIDS. 2001 Jan 5;15(1):F1-9.

Starting date: March 1999
Last updated: June 23, 2005