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

August 1, 2005
August 15, 2005
December 2001
Not Provided
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)
Proportion of patients who did not reach the criteria to resume antiretroviral treatment at W 72 (viral load over 30000cp/ml at two consecutive monthly samples and/or CD4 count below 350 /mm3 at two consecutive monthly samples )
Complete list of historical versions of study NCT00125814 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Structured Treatment Interruptions With or Without Pegylated Interferon Alpha for HIV-Infected Patients After Prolonged Viral Suppression
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)

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.

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).

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: Interferon alfa-2b
  • Procedure: Structured treatment interruptions
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
200
January 2005
Not Provided

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
Both
18 Years and older
Not Provided
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00125814
ANRS 105 INTERVAC
Not Provided
Not Provided
French National Agency for Research on AIDS and Viral Hepatitis
Schering-Plough
Principal Investigator: François Boue, MD Hopital Antoine Beclere service de Medecine Interne Clamart France
Study Chair: Dominique Costagliola INSERM U 720
French National Agency for Research on AIDS and Viral Hepatitis
August 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP