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

HIV Infections Clinical Trial

Official title:

Antiviral Activity and Tolerability of PEG-Intron in HIV-Infected Subjects Failing HAART

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005012
• Other study ID #: B010
• Secondary ID: P00737
• Status: Completed
• Phase: Phase 2
• First received: March 29, 2000
• Last updated: June 23, 2005
• Start date: March 2000
• Est. completion date: September 2000

Study information

• Verified date: August 2000
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: September 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Peginterferon alfa-2b

Locations

Country	Name	City	State
Puerto Rico	San Juan VAMC	San Juan
United States	IDC Research Initiative	Altamonte Springs	Florida
United States	Piedmont Physicians at Vinings	Atlanta	Georgia
United States	Univ of Maryland Institute of Human Virology	Baltimore	Maryland
United States	East Bay AIDS Ctr	Berkeley	California
United States	New England Med Ctr / Div of Geo Med & Infect Disease	Boston	Massachusetts
United States	Southwestern New Jersey AIDS Clinical Trials	Camden	New Jersey
United States	TRIAD Health Practice	Chicago	Illinois
United States	Univ Hosps of Cleveland	Cleveland	Ohio
United States	Amelia Ct Clinic	Dallas	Texas
United States	East Orange Veterans Administration Med Ctr	East Orange	New Jersey
United States	Joseph C Gathe	Houston	Texas
United States	Duval County Health Department	Jacksonville	Florida
United States	Univ of Miami School of Medicine	Miami	Florida
United States	Beth Israel Med Ctr	New York	New York
United States	MCP Hahnemann Univ	Philadelphia	Pennsylvania
United States	Philadelphia FIGHT	Philadelphia	Pennsylvania
United States	Infectious Diseases Associates	Sarasota	Florida
United States	Washington Univ	St. Louis	Missouri
United States	Regions Hosp	St. Paul	Minnesota
United States	Dupont Circle Physicians Group	Washington	District of Columbia
United States	Georgetown Univ Med Ctr	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Schering-Plough

Countries where clinical trial is conducted

United States,  Puerto Rico,