NCT00035360

Brief Summary

This is a randomized, double-blind, multicenter trial testing 2 doses of PEG-Intron, 1.0mcg/kg/week and 3.0mcg/kg/week in heavily treatment-experienced HIV-infected patients compared to placebo. The study will evaluate the efficacy and safety of PEG-Intron when added to stable optimized background antiretroviral therapy in this patient population.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at below P25 for phase_3 hiv-infections

Timeline
Completed

Started Mar 2002

Shorter than P25 for phase_3 hiv-infections

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2002

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 6, 2002

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2003

Completed
Last Updated

March 10, 2017

Status Verified

March 1, 2017

Enrollment Period

1.6 years

First QC Date

May 2, 2002

Last Update Submit

March 7, 2017

Conditions

HIV InfectionsAIDS

Keywords

PEG-Introntreatment experienced

Interventions

PEG-IntronDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV positive
  • History of virologic failure on at least 2 antiretroviral regimens including exposure to at least one NRTI, one NNRTI and one PI
  • HIV RNA \>400-\<50,000 copies/mL
  • Laboratory parameters: platelet count (75,000u/L, hemoglobin \>9gm/dl, absolute neutrophil count \>1,000/uL, SGOT/SGPT\<5xULN.

You may not qualify if:

  • Current ribavirin therapy
  • Subjects with a recent diagnosis or history of moderate or severe depression requiring ongoing psychiatric intervention
  • Females of childbearing potential who are breastfeeding, who are pregnant, or not using adequate birth control measures
  • Concomitant use of immunosuppressants or cytotoxic agents
  • History of seizure disorder requiring use of anticonvulsants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Interventions

peginterferon alfa-2b

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2002

First Posted

May 6, 2002

Study Start

March 1, 2002

Primary Completion

October 1, 2003

Study Completion

October 1, 2003

Last Updated

March 10, 2017

Record last verified: 2017-03