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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 Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about A Phase III Study Comparing Two Different Anti-HIV Drug Combinations in HIV-Positive Patients without Previous Anti-HIV Drug Therapy conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. A Phase III Study Comparing Two Different Anti-HIV Drug Combinations in HIV-Positive Patients without Previous Anti-HIV Drug Therapy Clinical research trials and A Phase III Study Comparing Two Different Anti-HIV Drug Combinations in HIV-Positive Patients without Previous Anti-HIV Drug Therapy health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as 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 Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a A Phase III Study Comparing Two Different Anti-HIV Drug Combinations in HIV-Positive Patients without Previous Anti-HIV Drug Therapy clinical trial. Human subjects frequently get the finest healthcare available for their A Phase III Study Comparing Two Different Anti-HIV Drug Combinations in HIV-Positive Patients without Previous Anti-HIV Drug Therapy condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > 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
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
Other Hiv Infections Studies:
1. Safety and Effectiveness of Nitazoxanide for the Treatment of Cryptosporidiosis in AIDS Patients
2. A Study of Two Anti-HIV Drug Combinations
3. A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Vaccinia-Derived HIV-1 Recombinant Envelope Glycoprotein (gp160)
4. Ganciclovir Implant Study for Cytomegalovirus Retinitis
5. A Study of Viracept in HIV-Positive Women
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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
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