Long-Term Supervised Treatment Interruption in HIV-Infected Patients

NCT00118677 | Completed Phase 3

• 1 other identifier: ANRS 116 SALTO
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

HIV Infections

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (8)

• 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

Interventions

Treatment interruption PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and non pregnant females
• 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

You may not qualify if:

• HBV-HIV co-infection receiving lamivudine therapy
• Ongoing immunotherapy including IL2, interferon or HIV specific vaccine
• Pregnancy or project of pregnancy

Sponsors & Collaborators

• French National Agency for Research on AIDS and Viral Hepatitis: lead

Study Sites (1)

Service d'immunologie Clinique, Höpital Européen Georges Pompidou

Paris, 75015, France

Location

Related Publications (1)

• 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.

  PMID: 20657770 DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Treatment Interruption

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Treatment Adherence and Compliance; Attitude to Health; Delivery of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Christophe Piketti, MD

  Hopital Georges Pompidou Paris France

  PRINCIPAL INVESTIGATOR

• Dominique Costagliola

  Inserm U720

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: July 1, 2005
• First Posted: July 12, 2005
• Study Start: February 1, 2003
• Study Completion: May 1, 2007
• Last Updated: August 30, 2007

Record last verified: 2007-08

Locations

FR (1)