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Safety and Effectiveness of PEG-Intron in HIV-Infected Patients Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Safety and Effectiveness of PEG-Intron in HIV-Infected Patients conditions. Clinical Trials Search.org is a website devoted 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 evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as 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 permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Safety and Effectiveness of PEG-Intron in HIV-Infected Patients clinical trial. Subjects often receive the most expert healthcare possible for their Safety and Effectiveness of PEG-Intron in HIV-Infected Patients condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed 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 Study to See If Taking One or Two Extra Drugs Can Lower HIV Levels in Patients Who Have Failed Their Anti-HIV Drug Treatment
2. The Safety and Effectiveness of RMP-7 Plus Amphotericin B in Patients with HIV and Cryptococcal Meningitis
3. A Study of the Safety and Effectiveness of Combination Anti-HIV Therapy in HIV-Infected Adults
4. A Study to Evaluate the Effects of Anti-HIV Drugs in HIV-Positive Patients Who Also Have Hepatitis C Infection
5. A Study of ISIS 2922 in the Treatment of Advanced Cytomegalovirus Retinitis
Related Studies:
Other HIV Infections Clinical Trials
Other Texas Clinical Trials
Other Dallas Clinical Trials
Safety and Effectiveness of PEG-Intron in HIV-Infected Patients
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