Completed

PEG-IFN Antiviral Activity in HIV Patients Failing HAART

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Study Aim

This phase 2 study aims to evaluate the antiviral activity of PEG-IFN treatment in HIV patients who are not responding well to their current HAART therapy.

What is being tested

Peginterferon alfa-2b

Drug
Who is being recruted

Blood-Borne Infections+11

+ Urogenital Diseases

+ Genital Diseases

+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: March 2000
See protocol details

Summary

Principal SponsorSchering-Plough
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2000

Actual date on which the first participant was enrolled.

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.

NCT00005012
Principal SponsorSchering-Plough
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

250 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsHIV Infections

Criteria

6 inclusion criteria required to participate
Agree to use an effective method of birth control during the study
Have HIV levels of more than 2000 copies/ml
Have a CD4 cell count greater than 200 cells/microL
Have been on their current HAART for at least 6 weeks
Show More Criteria
4 exclusion criteria prevent from participating
Are allergic to interferons
Are pregnant or breast-feeding
Are taking certain medications such as ribavirin, hydroxyurea, and ganciclovir
Have a history of a serious mental disorder

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 22 locations

East Bay AIDS Ctr

Berkeley, United StatesOpen East Bay AIDS Ctr in Google Maps

Georgetown Univ Med Ctr

Washington D.C., United States

Dupont Circle Physicians Group

Washington D.C., United States

IDC Research Initiative

Altamonte Springs, United States
Completed22 Study Centers