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

History of Changes

Tracking Information

First Received Date ^ICMJE

July 1, 2005

Last Updated Date

August 29, 2007

Start Date ^ICMJE

February 2003

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Proportion of patients who did not resume antiretroviral treatment at 12 months

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00118677 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Long-Term Supervised Treatment Interruption in HIV-Infected Patients

Official Title ^ICMJE

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

Brief Summary

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.

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 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).

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

Procedure: Treatment interruption

Study Arm (s)

Not Provided

Publications *

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.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

130

Completion Date

May 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT00118677

Other Study ID Numbers ^ICMJE

ANRS 116 SALTO

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

French National Agency for Research on AIDS and Viral Hepatitis

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Christophe Piketti, MD	Hopital Georges Pompidou Paris France
Study Chair:	Dominique Costagliola	Inserm U720

Information Provided By

French National Agency for Research on AIDS and Viral Hepatitis

Verification Date

August 2007

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

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