Structured Treatment Interruptions With or Without Pegylated Interferon Alpha for HIV-Infected Patients After Prolonged Viral Suppression

This study has been terminated.
Sponsor:
Collaborator:
Schering-Plough
Information provided by:
French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:
NCT00125814
First received: August 1, 2005
Last updated: August 15, 2005
Last verified: August 2005
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Interferon alfa-2b
Procedure: Structured treatment interruptions
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multi-Center Trial to Evaluate the Efficacy and Safety of Structured Treatment Interruptions With or Without Pegylated Interferon Alpha for HIV-Infected Patients After Prolonged Viral Suppression (ANRS 105 INTERVAC)

Resource links provided by NLM:


Further study details as provided by French National Agency for Research on AIDS and Viral Hepatitis:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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

Estimated Enrollment: 200
Study Start Date: December 2001
Estimated Study Completion Date: January 2005
Detailed Description:

The limitations of the drugs used against HIV include their toxicity, their tolerability, their propensity to induce resistance when not taken with absolute regularity and their cost. Treatment interruption in patients receiving antiretroviral treatment in the setting of chronic infection is associated with viral rebound and rapid CD4 T cell decrease conducting to antiretroviral therapy restart. In patients with high CD4+ cell counts (patients receiving treatment of chronic infection with controlled viremia and patients who are receiving highly active antiretroviral therapy (HAART) now in whom treatment would not have been started based on current guidelines), the investigators evaluated whether the adjunctional of interferon alfa 2b to 3 structured treatment interruptions correlated with a long time off treatment. HAART was interrupted for 4 weeks, restarted and continued for 12 weeks. After 3 such cycles treatment was indefinitely suspended 48 weeks after study entry. Another aim of this study was to assess the immunological and virological factors associated with the duration of treatment interruption (proviral HIV DNA at baseline and during follow-up, plasma HIV RNA at baseline and during follow-up, CD4 T cell and CD8 T cell HIV specific responses at baseline and after 6 months of interruption).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Males and non pregnant females
  • Confirmed laboratory diagnosis of HIV infection
  • Have been on the same continuous HAART regimen for at least 6 months prior to inclusion
  • 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.

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00125814

Locations
France
Service de Medecine Interne
Clamart, France, 92140
Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
Schering-Plough
Investigators
Principal Investigator: François Boue, MD Hopital Antoine Beclere service de Medecine Interne Clamart France
Study Chair: Dominique Costagliola INSERM U 720
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00125814     History of Changes
Other Study ID Numbers: ANRS 105 INTERVAC
Study First Received: August 1, 2005
Last Updated: August 15, 2005
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:
Interferon Alfa-2b
HIV infections

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Interferon-alpha
Interferons
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 26, 2014