Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00125814
Recruitment Status : Terminated
First Posted : August 2, 2005
Last Update Posted : August 16, 2005
Sponsor:
Collaborator:
Schering-Plough
Information provided by:
French National Agency for Research on AIDS and Viral Hepatitis

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

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

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).
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : December 2001
Study Completion Date : January 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  1. Viral rebound one and 3 months after stopping all antiviral treatments
  2. Specific anti-HIV CD4 and CD8 response
  3. Proviral HIV DNA at baseline and during follow-up
  4. Description of genetic HIV viral mutations during procedure
  5. Safety

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00125814


Locations
Layout table for location information
France
Service de Medecine Interne
Clamart, France, 92140
Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
Schering-Plough
Investigators
Layout table for investigator information
Principal Investigator: François Boue, MD Hopital Antoine Beclere service de Medecine Interne Clamart France
Study Chair: Dominique Costagliola INSERM U 720
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00125814    
Other Study ID Numbers: ANRS 105 INTERVAC
First Posted: August 2, 2005    Key Record Dates
Last Update Posted: August 16, 2005
Last Verified: August 2005
Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:
Interferon Alfa-2b
HIV infections
Additional relevant MeSH terms:
Layout table for MeSH terms
HIV Infections
Infections
Blood-Borne Infections
Communicable Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Immunologic Deficiency Syndromes
Immune System Diseases
Interferons
Interferon-alpha
Interferon alpha-2
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs