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Safety and Effectiveness of PEG-Intron in HIV-Infected Patients Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Safety and Effectiveness of PEG-Intron in HIV-Infected Patients conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Safety and Effectiveness of PEG-Intron in HIV-Infected Patients Clinical research trials and Safety and Effectiveness of PEG-Intron in HIV-Infected Patients medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Safety and Effectiveness of PEG-Intron in HIV-Infected Patients. Safety and Effectiveness of PEG-Intron in HIV-Infected Patients Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Safety and Effectiveness of PEG-Intron in HIV-Infected Patients clinical trial. Subjects typically recieve the finest healthcare available for their Safety and Effectiveness of PEG-Intron in HIV-Infected Patients condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Safety and Effectiveness of PEG-Intron in HIV-Infected Patients Safety and Effectiveness of PEG-Intron in HIV-Infected Patients
Safety and Effectiveness of PEG-Intron in HIV-Infected Patients
For Condition: HIV Infections
Status: Completed
Sponsor(s): Schering-Plough ,
Synopsis: The purpose of this study is to see if it is effective to give PEG-Intron (PEG-IFN) to HIV-infected patients who are not doing well with their current anti-HIV drug combination (HAART).
Details: At entry, patients undergo HIV genotypic/phenotypic analysis. Patients continue their current antiretroviral regimen but are randomized to receive one of four doses of PEG-IFN or PEG-IFN placebo administered subcutaneously once per week until results of HIV genotyping/phenotyping are available (approximately 4 weeks). Patients who respond with a 0.5 log or greater decrease in HIV RNA at Week 4 have optimized HAART added to their ongoing PEG-IFN regimen and are followed for 24 weeks in an observational study.
Eligibility:
Study Type: Interventional, Treatment, Efficacy Study
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients may be eligible for this study if they: - Have HIV levels of more than 2000 copies/ml. - Have failed their current HAART (had a significant increase in their HIV levels with HAART). - Have a CD4 cell count greater than 200 cells/microL. - Have had more than 6 months of HAART. - Have been on their current HAART for at least 6 weeks. - Agree to use an effective method of birth control during the study. Exclusion Criteria Patients will not be eligible for this study if they: - Have a history of a serious mental disorder. - Are allergic to interferons. - Are pregnant or breast-feeding. - Are taking certain medications such as ribavirin, hydroxyurea, and ganciclovir.
Total Enrollment: 250
Location and Contact Information:
IDC Research Initiative
Altamonte Springs, Florida, 32701
United States
Amelia Ct Clinic
Dallas, Texas, 75235
United States
MCP Hahnemann Univ
Philadelphia, Pennsylvania, 19102
United States
Joseph C Gathe
Houston, Texas, 77004
United States
New England Med Ctr / Div of Geo Med & Infect Disease
Boston, Massachusetts, 02111
United States
East Bay AIDS Ctr
Berkeley, California, 94705
United States
Piedmont Physicians at Vinings
Atlanta, Georgia, 30339
United States
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19107
United States
Regions Hosp
St. Paul, Minnesota, 55101
United States
Southwestern New Jersey AIDS Clinical Trials
Camden, New Jersey, 08103
United States
East Orange Veterans Administration Med Ctr
East Orange, New Jersey, 07018
United States
Duval County Health Department
Jacksonville, Florida, 32206
United States
Infectious Diseases Associates
Sarasota, Florida, 34239
United States
San Juan VAMC
San Juan, , 009265800
Puerto Rico
TRIAD Health Practice
Chicago, Illinois, 60657
United States
Univ Hosps of Cleveland
Cleveland, Ohio, 44106
United States
Washington Univ
St. Louis, Missouri, 63110
United States
Beth Israel Med Ctr
New York City, New York, 10003
United States
Univ of Miami School of Medicine
Miami, Florida, 33136
United States
Dupont Circle Physicians Group
Washington D.C., District of Columbia, 200091104
United States
Univ of Maryland Institute of Human Virology
Baltimore, Maryland, 212011192
United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
United States
Additional Information:
Study ID Numbers: B010; P00737
Study Start Date: March 2000
Record last reviewed: August 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005012
Other Hiv Infections Studies:
1. A Phase I Trial of Peptide T: Efficacy for the Neuropsychiatric Complications of Acquired Immunodeficiency Syndrome (AIDS).
2. A Study to Evaluate the Effect of Anti-HIV Therapy on Lean Tissue (Muscle) in HIV-Positive Patients
3. A Pilot Trial Evaluating an Alternating Schedule of Recombinant Human GM-CSF and Azidothymidine in Patients With HIV Infection and Leukopenia
4. A Study of Two Forms of Pentamidine in the Treatment of Pneumocystis carinii Pneumonia (PCP) in Patients with AIDS
5. A Study to Evaluate the Safety and Effectiveness of WF10 Given to Patients with Late-Stage HIV Disease
Related Studies:
Other HIV Infections Clinical Trials
Other New Jersey Clinical Trials
Other East Orange Clinical Trials
Safety and Effectiveness of PEG-Intron in HIV-Infected Patients
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