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



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

For Condition: HIV Infections
Status: Completed
Sponsor(s): Abbott Laboratories ,
Synopsis: 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.
Details: 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:
Study Type:
  Interventional, Treatment, Double-Blind, Efficacy Study
Minimum Age/Maximum Age: 12 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 660

Location and Contact Information:

Oaklawn Physicians Group
Dallas,  Texas,  75219
United States
 

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

Infectious Disease Research Institute
Tampa,  Florida,  33614
United States
 

Alfred Hosp
Prahan,  , 
Australia
 

Abbott Northwestern Hosp
Minneapolis,  Minnesota,  55407
United States
 

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

Royal Free Hosp
London,  , 
United Kingdom
 

Allgemeines Krankenhaus St Georg
Hamburg,  , 
Germany
 

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

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

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

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

Vanderbilt Univ Med Ctr
Nashville,  Tennessee,  37203
United States
 

Heinrich Heine Universitat
Dusseldorf,  , 
Germany
 

Castelo
Sao Paulo,  , 
Brazil
 

Univ of Wisconsin
Madison,  Wisconsin,  53792
United States
 

Hosp Doce De Octubre
Madrid,  , 
Spain
 

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

UCLA CARE Ctr
Los Angeles,  California,  90095
United States
 

Hopital Paul Brousse
Villejuif,  , 
France
 

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

AIDS Healthcare Foundation
Los Angeles,  California,  900276069
United States
 

Toronto Gen Hosp
Toronto,  Ontario, 
Canada
 

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

Hvidovre Univ Hosp
Hvidovre,  , 
Denmark
 

Montreal Chest Institute
Montreal,  Quebec, 
Canada
 

Philadelphia FIGHT
Philadelphia,  Pennsylvania,  19107
United States
 

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

Klinikum Der Johann Wolfgang Goethe Universitat
Frankfurt,  , 
Germany
 

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

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

The Miriam Hosp
Providence,  Rhode Island,  02906
United States
 

Hosp Do Servidor Publico Estadual De Sao Paulo
Sao Paulo,  , 
Brazil
 

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

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

CHU De Bicetre
Paris,  , 
France
 

Centre Hospitalier De Compiegne
Compiegne,  , 
France
 

Saint Paul's Hosp
Vancouver,  British Columbia, 
Canada
 

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

Univ Zu Koeln
Koeln,  , 
Germany
 

Ottawa General Hospital
Ottawa,  Ontario, 
Canada
 

EPIMED
Berlin,  , 
Germany
 

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

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

Brighton Gen Hosp
Brighton,  , 
United Kingdom
 

Fundacao Zerbini Casa Da Aids
Sao Paulo,  , 
Brazil
 

Hosp De Mostoles
Madrid,  , 
Spain
 

Clinique Medicale du Quartier Latin
Montreal,  Quebec, 
Canada
 

Emory Univ
Atlanta,  Georgia,  30308
United States
 

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

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

Hosp Evandro Chagas Fioernz
Manguinhos RJ,  , 
Brazil
 

Joseph C Gathe
Houston,  Texas,  77004
United States
 

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

Pulmologisches Zentrum Der Stadt Wien
Wien,  , 
Austria
 

Wits Medical School
PARKTOWN,  , 
South Africa
 

Righospitalet
Copenhagen,  , 
Denmark
 

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

Clinique Medicale L'Actuele
Montreal,  Quebec, 
Canada
 

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

Ctr of AIDS Diagnosis and Treatment
Warszawa,  , 
Poland
 

Stephen Hauptman
Philadelphia,  Pennsylvania,  19107
United States
 

Hosp Germans Trias I Pujol
Barcelona,  , 
Spain
 

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

Royal Brisbane Hosp
HERSTON,  , 
Australia
 

Johns Hopkins Hosp
Baltimore,  Maryland,  21205
United States
 

Oregon Health Sciences Univ
Portland,  Oregon,  972109951
United States
 

Imperial College School of Medicine
London,  , 
United Kingdom
 

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

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

Steinhart Medical Associates
Miami,  Florida,  33133
United States
 

Central Texas Med Foundation
Austin,  Texas,  78751
United States
 

Hosp La Paz
Madrid,  , 
Spain
 

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

Hosp Carlos III
Madrid,  , 
Spain
 

Universitatsspital Zurich
Zurich,  , 
Switzerland
 

Royal Perth Hosp
Perth,  , 
Australia
 

Infectious Disease Physicians Inc
Annandale,  Virginia,  22203
United States
 

Miller
Belford Gardens,  , 
South Africa
 

Hosp Virgen Del Rocio
Sevilla,  , 
Spain
 

Boston Med Ctr
Boston,  Massachusetts,  02118
United States
 

Hosp Heliopolis
Sao Paulo,  , 
Brazil
 

Cyrildene
Johannesburg,  , 
South Africa
 


Additional Information:
Study ID Numbers:
  285C;  M98-863
Study Start Date: March 1999
Record last reviewed: January 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004583

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