Long-Term Supervised Treatment Interruption in HIV-Infected Patients

This study has been completed.
Sponsor:
Information provided by:
French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:
NCT00118677
First received: July 1, 2005
Last updated: August 29, 2007
Last verified: August 2007

July 1, 2005
August 29, 2007
February 2003
Not Provided
Proportion of patients who did not resume antiretroviral treatment at 12 months
Same as current
Complete list of historical versions of study NCT00118677 on ClinicalTrials.gov Archive Site
  • Time to resume antiretroviral treatment with CD4 cell count equal or below 300/mm3
  • Proportion of patients who did not resume antiretroviral treatment at M 24 and M 36
  • Predictive factors associated with the time of restart of antiretroviral therapy: 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 12 months
  • Change in lipodystrophy clinical score and quality of life during the follow-up
  • Criteria to resume antiretroviral treatment: CD4T cell count below or equal to 300/mm3
  • The occurrence of an AIDS defining event
Same as current
Not Provided
Not Provided
 
Long-Term Supervised Treatment Interruption in HIV-Infected Patients
Long-Term Supervised Treatment Interruption in HIV-Infected Patients Who Started Antiretroviral Treatment With CD4 Over 350/mm3 and Plasma HIV RNA Below 50 000/mL ANRS 116 Trial SALTO

This trial is aimed at studying the safety of long term supervised treatment interruption in HIV infected patients with CD4 over 350/mm3 and plasma HIV RNA under 50 000/mL. Another aim of this study is to assess the immunological and virological factors associated with the duration of treatment interruption.

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 are 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 HAART now in whom treatment would not have been started based on current guidelines), we evaluated the safety of long term supervised treatment interruption. 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 12 months).

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
Procedure: Treatment interruption
Not Provided
Weiss L, Piketty C, Assoumou L, Didier C, Caccavelli L, Donkova-Petrini V, Levy Y, Girard PM, Burgard M, Viard JP, Rouzioux C, Costagliola D; ANRS 116 SALTO study group. Relationship between regulatory T cells and immune activation in human immunodeficiency virus-infected patients interrupting antiretroviral therapy. PLoS One. 2010 Jul 21;5(7):e11659.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
130
May 2007
Not Provided

Inclusion Criteria:

  • Males and non pregnant females
  • 18 years of age and older
  • Who have confirmed laboratory diagnosis of HIV infection
  • Started on first line antiretroviral treatment with CD4 over 350/mm3 and plasma HIV RNA below 50 000/mL
  • Ongoing Antiretroviral therapy at inclusion with CD4 over 450/mm3 and plasma HIV RNA below 5000/mL

Exclusion Criteria:

  • HBV-HIV co-infection receiving lamivudine therapy
  • Ongoing immunotherapy including IL2, interferon or HIV specific vaccine
  • Pregnancy or project of pregnancy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00118677
ANRS 116 SALTO
Not Provided
Not Provided
French National Agency for Research on AIDS and Viral Hepatitis
Not Provided
Principal Investigator: Christophe Piketti, MD Hopital Georges Pompidou Paris France
Study Chair: Dominique Costagliola Inserm U720
French National Agency for Research on AIDS and Viral Hepatitis
August 2007

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