NCT00125814

Brief Summary

The purpose of this study is to determine whether the adjunctional of interferon alfa to structured treatment interruptions correlated with a long time off treatment in HIV-1 infection.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
200

participants targeted

Target at P25-P50 for phase_3 hiv-infections

Timeline
Completed

Started Dec 2001

Geographic Reach
1 country

1 active site

Status
terminated

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

December 1, 2001

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 2, 2005

Completed
Last Updated

August 16, 2005

Status Verified

August 1, 2005

First QC Date

August 1, 2005

Last Update Submit

August 15, 2005

Conditions

HIV Infections

Keywords

Interferon Alfa-2bHIV infections

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients who did not reach the criteria to resume antiretroviral treatment at week 72 [W 72] (viral load over 30000 cp/ml at two consecutive monthly samples and/or CD4 count below 350/mm3 at two consecutive monthly samples)

Secondary Outcomes (5)

  • Viral rebound one and 3 months after stopping all antiviral treatments

  • Specific anti-HIV CD4 and CD8 response

  • Proviral HIV DNA at baseline and during follow-up

  • Description of genetic HIV viral mutations during procedure

  • Safety

Interventions

Interferon alfa-2bDRUG
Structured treatment interruptionsPROCEDURE

Eligibility Criteria

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

You may qualify if:

  • Males and non pregnant females
  • Confirmed laboratory diagnosis of HIV infection
  • Viral load below 50 cp/ml for at least 6 months
  • CD4 over 350 cells/mm3
  • Previous viral load over 10000 cp/ml in their history
  • No CD4 cell count under 100/mm3 in their history
  • For women of reproductive ages: negative serum pregnancy test
  • Signed written consent to participate.

You may not qualify if:

  • Already had interferon or interleukin-2 (IL-2)
  • Positive hepatitis C virus (HCV) PCR
  • Under treatment with abacavir during screening
  • Serious psychiatric history, suicide attempt, or severe depression
  • History of thyroid abnormality
  • Opportunistic infection ongoing
  • Lymphoma or Kaposi's sarcoma (KS) under chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Medecine Interne

Clamart, 92140, France

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Interferon alpha-2

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Interferon-alphaInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • François Boue, MD

    Hopital Antoine Beclere service de Medecine Interne Clamart France

    PRINCIPAL INVESTIGATOR

  • Dominique Costagliola

    INSERM U 720

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

August 1, 2005

First Posted

August 2, 2005

Study Start

December 1, 2001

Study Completion

January 1, 2005

Last Updated

August 16, 2005

Record last verified: 2005-08

Locations

FR(1)