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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Peginterferon alfa-2b
Sponsored by
Schering-Plough
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Interferon Alfa-2b, Lymphocyte Transformation, CD4 Lymphocyte Count, RNA, Viral, Virus Inhibitors, Anti-HIV Agents, Viral Load

Eligibility Criteria

0 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • East Bay AIDS Ctr
  • Georgetown Univ Med Ctr
  • Dupont Circle Physicians Group
  • IDC Research Initiative
  • Duval County Health Department
  • Univ of Miami School of Medicine
  • Infectious Diseases Associates
  • Piedmont Physicians at Vinings
  • TRIAD Health Practice
  • Univ of Maryland Institute of Human Virology
  • New England Med Ctr / Div of Geo Med & Infect Disease
  • Regions Hosp
  • Washington Univ
  • Southwestern New Jersey AIDS Clinical Trials
  • East Orange Veterans Administration Med Ctr
  • Beth Israel Med Ctr
  • Univ Hosps of Cleveland
  • MCP Hahnemann Univ
  • Philadelphia FIGHT
  • Amelia Ct Clinic
  • Joseph C Gathe
  • San Juan VAMC

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 29, 2000
Last Updated
June 23, 2005
Sponsor
Schering-Plough
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1. Study Identification

Unique Protocol Identification Number
NCT00005012
Brief Title
Safety and Effectiveness of PEG-Intron in HIV-Infected Patients
Official Title
Antiviral Activity and Tolerability of PEG-Intron in HIV-Infected Subjects Failing HAART
Study Type
Interventional

2. Study Status

Record Verification Date
August 2000
Overall Recruitment Status
Completed
Study Start Date
March 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2000 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Schering-Plough

4. Oversight

5. Study Description

Brief Summary
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).
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Interferon Alfa-2b, Lymphocyte Transformation, CD4 Lymphocyte Count, RNA, Viral, Virus Inhibitors, Anti-HIV Agents, Viral Load

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
250 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Peginterferon alfa-2b

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
East Bay AIDS Ctr
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
Facility Name
Georgetown Univ Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Dupont Circle Physicians Group
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
200091104
Country
United States
Facility Name
IDC Research Initiative
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
Facility Name
Duval County Health Department
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32206
Country
United States
Facility Name
Univ of Miami School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Infectious Diseases Associates
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Piedmont Physicians at Vinings
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30339
Country
United States
Facility Name
TRIAD Health Practice
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Univ of Maryland Institute of Human Virology
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
212011192
Country
United States
Facility Name
New England Med Ctr / Div of Geo Med & Infect Disease
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Regions Hosp
City
St. Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Facility Name
Washington Univ
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Southwestern New Jersey AIDS Clinical Trials
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
East Orange Veterans Administration Med Ctr
City
East Orange
State/Province
New Jersey
ZIP/Postal Code
07018
Country
United States
Facility Name
Beth Israel Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Univ Hosps of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
MCP Hahnemann Univ
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
Philadelphia FIGHT
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Amelia Ct Clinic
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Joseph C Gathe
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
San Juan VAMC
City
San Juan
ZIP/Postal Code
009265800
Country
Puerto Rico

12. IPD Sharing Statement

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

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