Clinical trial NCT00005012: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: Interferon Alfa-2b
Lymphocyte Transformation
CD4 Lymphocyte Count
RNA, Viral
Virus Inhibitors
Anti-HIV Agents
Viral Load
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 250
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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.

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