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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

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Safety and Effectiveness of PEG-Intron in HIV-Infected Patients

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