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Home > "P" Clinical Trials Conditions > Phase III PEG-Intron in HIV-infected patients  Phase III PEG-Intron in HIV-infected patients
Phase III PEG-Intron in HIV-infected patients
For Condition: HIV Infections,AIDS
Status: Completed
Sponsor(s): Schering-Plough ,
Synopsis: This is a randomized, double-blind, multicenter trial testing 2 doses of PEG-Intron, 1.0mcg/kg/week and 3.0mcg/kg/week in heavily treatment-experienced HIV-infected patients compared to placebo. The study will evaluate the efficacy and safety of PEG-Intron when added to stable optimized background antiretroviral therapy in this patient population.
Details: This study will randomize 675 patients (225 in each of the 3 arms) to either: PEG-Intron 1mcg; 3mcg or Placebo, at 90 centers worldwide. Each center will enroll approximately 10 patients. Study drug will be added to optimized background anti-retroviral therapy of patients whose HIV RNA is incompletely suppressed by their therapy (HIV RNA 400-50,000 copies/ML) after 2-6 months. A single dose reduction of 50% will be allowed for toxicity. An Interim Analysis will be conducted when 50% of patients have completed 24 weeks of therapy. The study treatment phase will be 48 weeks with monthly visits for virologic virologic and safety monitoring. The primary endpoint is change in HIV RNA from baseline to week to assess efficacy. Durability of response will be assessed at 48 weeks.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - HIV positive - History of virologic failure on at least 2 antiretroviral regimens including exposure to at least one NRTI, one NNRTI and one PI - HIV RNA >400-<50,000 copies/mL - Laboratory parameters: platelet count (75,000u/L, hemoglobin >9gm/dl, absolute neutrophil count >1,000/uL, SGOT/SGPT<5xULN. Exclusion Criteria: - Current ribavirin therapy - Subjects with a recent diagnosis or history of moderate or severe depression requiring ongoing psychiatric intervention - Females of childbearing potential who are breastfeeding, who are pregnant, or not using adequate birth control measures - Concomitant use of immunosuppressants or cytotoxic agents - History of seizure disorder requiring use of anticonvulsants
Total Enrollment: 675
Location and Contact Information:
Hudson Medical Group
Atlanta, Georgia,
United States
Hospital de Clinicas da Universidade Federal do Parano
Curitiba, ,
Brazil
HIV Immunology Clinic
Oakland, California,
United States
Amelia Court HIV Research Clinic
Dallas, Texas,
United States
Infectious Disease Research Institute, Inc.
Tampa, Florida,
United States
VA Medical Center
Miami, Florida,
United States
University of Miami School of Medicine
Miami, Florida,
United States
University of Texas
Houston, Texas,
United States
San Juan VA medical Center
San Juan, ,
Puerto Rico
Washington University
Albany, New York,
United States
Dr DJ Martin Private Practice
Johannesburg, ,
South Africa
North Texas Center for AIDS and Clinical Research
Dallas, Texas,
United States
Harbor-UCLA Research and Education Institute
Torrance, California,
United States
Infectious Diseases Syndicate
Johannesburg, ,
South Africa
Northwest Medical Specialties
Tacoma, Washington,
United States
Clinical Research Puerto Rico, Inc.
San Juan, ,
Puerto Rico
Hospital De Infecciosas Francisco J. Muniz
Buenos Aires, ,
Argentina
Dr. DJ Martin Private Practice
Johannesburg, ,
South Africa
Community Research Initiative of New England
Springfield, Massachusetts,
United States
Hospital Universitario Virgen del Rocio
Sevilla, ,
Spain
Albany Medical College Clinical Pharmacology Study Unit
Albany, New York,
United States
4900 Fannin Street
Houston, Texas,
United States
Fundacao Oswaldo Cruz - Centro de Pesq Hospital
Rio de Janeiro, ,
Brazil
Beth Israel Medical Center
New York City, New York,
United States
Fundacion Huesped
Buenos Aires, ,
Argentina
St. Micheal's Medical Center
Newark, New Jersey,
United States
Centro de Referencia e Treinamento em DST/AIDS
Sao Paulo, ,
Brazil
South Jersey Infectious Disease
Somers Point, New Jersey,
United States
Cooper Hospital
Camden, New Jersey,
United States
Evans Biomedical Research Center
Boston, Massachusetts,
United States
Hospital das Clinicas da UFMG
Belo Horizonte, ,
Brazil
University of Kansas School of Medicine-Wichita
Wichita, Kansas,
United States
EM DST/Aids
San Paulo, ,
Spain
Dupont Circle Physician's Group
Washington D.C., District of Columbia,
United States
Hospital Nacional Guillermo Irigoyen
Lima, ,
Peru
Boulevard Comprehensive Care Center
Jacksonville, Florida,
United States
Irigoyen
Lima, ,
Peru
Dr. Robert Scott - Internal Medicine
Oakland, California,
United States
Infectious Disease Associates
Sarasota, Florida,
United States
Casa Da AIDS
Sao Paulo, ,
Brazil
Tower ID Medical Associates
Los Angeles, California,
United States
Hospital Universitario Virgen del Rocio
Sevilla, ,
Spain
IDC Research Initiative
Altamonte Springs, Florida,
United States
Harbor-UCLA Research and Education Institute
Torrance, California,
United States
Lehigh Valley Hospital
Allentown, Pennsylvania,
United States
Centro Medico Nacional La Raza I.M.S.S.
Mexico, D.F., ,
Mexico
Methodist Healthcare
Memphis, Tennessee,
United States
Tan Tock Seng Hospital
Singapore, ,
Singapore
North Texas ID Consultants
Dallas, Texas,
United States
Additional Information:
Study ID Numbers: P00738;
Study Start Date: April 2002
Record last reviewed: May 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00035360
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2. CSP #512 - Options in Management with Anti-Retrovirals (OPTIMA)
3. L-Carnitine to Treat Fatigue in AIDS Patients
4. Relaxation Response with Acupuncture for HIV Patients
5. Distant Healing for HIV/AIDS
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Phase III PEG-Intron in HIV-infected patients
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