A Phase III Study Comparing Two Different Anti-HIV Drug Combinations in HIV-Positive Patients Without Previous Anti-HIV Drug Therapy
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
2 other identifiers
interventional
660
13 countries
80
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 hiv-infections
80 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 1999
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedFebruary 20, 2009
February 1, 2009
November 2, 1999
February 19, 2009
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbottlead
Study Sites (83)
Pacific Oaks Med Group
Beverly Hills, California, 90211, United States
Orange County Ctr for Special Immunology
Fountain Valley, California, 92708, United States
AIDS Healthcare Foundation
Los Angeles, California, 900276069, United States
Tower ID Med Associates
Los Angeles, California, 90048, United States
UCLA CARE Ctr
Los Angeles, California, 90095, United States
San Francisco Veterans Administration Med Ctr
San Francisco, California, 94121, United States
Harbor - UCLA Med Ctr
Torrance, California, 90502, 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
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308, United States
Emory Univ
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
Beth Israel Med Ctr
New York, New York, 10003, United States
Cornell Clinical Trials Unit - Chelsea Clinic
New York, New York, 10011, 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
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
Oregon Health Sciences Univ
Portland, Oregon, 972109951, United States
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19107, United States
Stephen Hauptman
Philadelphia, Pennsylvania, 19107, United States
The Miriam Hosp
Providence, Rhode Island, 02906, United States
Vanderbilt Univ Med Ctr
Nashville, Tennessee, 37203, United States
Central Texas Med Foundation
Austin, Texas, 78751, United States
Oaklawn Physicians Group
Dallas, Texas, 75219, United States
Univ of Texas Southwestern Med Ctr
Dallas, Texas, 75235, 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
Royal Brisbane Hosp
Herston, Australia
Royal Perth Hosp
Perth, Australia
Alfred Hosp
Prahan, Australia
Pulmologisches Zentrum Der Stadt Wien
Vienna, Austria
Hosp Evandro Chagas Fioernz
Manguinhos RJ, Brazil
Castelo
São Paulo, Brazil
Fundacao Zerbini Casa Da Aids
São Paulo, Brazil
Hosp Do Servidor Publico Estadual De Sao Paulo
São Paulo, Brazil
Hosp Heliopolis
São Paulo, Brazil
Saint Paul's Hosp
Vancouver, British Columbia, Canada
Ottawa General Hospital
Ottawa, Ontario, Canada
Toronto Gen Hosp
Toronto, Ontario, Canada
Clinique Medicale du Quartier Latin
Montreal, Quebec, Canada
Clinique Medicale L'Actuele
Montreal, Quebec, Canada
Montreal Chest Institute
Montreal, Quebec, Canada
Righospitalet
Copenhagen, Denmark
Hvidovre Univ Hosp
Hvidovre, Denmark
Centre Hospitalier De Compiegne
Compiègne, France
CHU De Bicetre
Paris, France
Groupe Hospitalier Bichat-Claude Bernard
Paris, France
Hopital Paul Brousse
Villejuif, France
EPIMED
Berlin, Germany
Univ Zu Koeln
Cologne, Germany
Heinrich Heine Universitat
Düsseldorf, Germany
Klinikum Der Johann Wolfgang Goethe Universitat
Frankfurt, Germany
Allgemeines Krankenhaus St Georg
Hamburg, Germany
Ctr of AIDS Diagnosis and Treatment
Warsaw, Poland
Clinical Research Puerto Rico Inc
San Juan, 00909, Puerto Rico
Miller
Belford Gardens, South Africa
Cyrildene
Johannesburg, South Africa
Wits Medical School
Parktown, South Africa
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
Seville, Spain
Universitatsspital Zurich
Zurich, Switzerland
Brighton Gen Hosp
Brighton, United Kingdom
Imperial College School of Medicine
London, United Kingdom
Royal Free Hosp
London, United Kingdom
Related Publications (1)
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. doi: 10.1097/00002030-200101050-00002.
PMID: 11192874BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Start
March 1, 1999
Last Updated
February 20, 2009
Record last verified: 2009-02