Long-Term Supervised Treatment Interruption in HIV-Infected Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2007-05-31

Brief Summary

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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

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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).

Conditions

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HIV Infections

Keywords

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HIV Infections

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Treatment interruption

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Christophe Piketti, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Georges Pompidou Paris France

Dominique Costagliola

Role: STUDY_CHAIR

Inserm U720

Locations

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Service d'immunologie Clinique, Höpital Européen Georges Pompidou

Paris, , France

Site Status

Countries

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France

References

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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. doi: 10.1371/journal.pone.0011659.

Reference Type DERIVED

PMID: 20657770 (View on PubMed)

Other Identifiers

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ANRS 116 SALTO

Identifier Type: -

Identifier Source: org_study_id