Long-Term Supervised Treatment Interruption in HIV-Infected Patients

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00118677
• Other study ID #: ANRS 116 SALTO
• Status: Completed
• Phase: Phase 3
• First received: July 1, 2005
• Last updated: August 29, 2007
• Start date: February 2003
• Est. completion date: May 2007

Study information

• Verified date: August 2007
• Source: French National Agency for Research on AIDS and Viral Hepatitis
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Procedure:
• Treatment interruption

Locations

Country	Name	City	State
France	Service d'immunologie Clinique, Höpital Européen Georges Pompidou	Paris

Sponsors (1)

Lead Sponsor	Collaborator
French National Agency for Research on AIDS and Viral Hepatitis

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients who did not resume antiretroviral treatment at 12 months
Secondary	Time to resume antiretroviral treatment with CD4 cell count equal or below 300/mm3
Secondary	Proportion of patients who did not resume antiretroviral treatment at M 24 and M 36
Secondary	Predictive factors associated with the time of restart of antiretroviral therapy: Proviral HIV DNA at baseline and during follow-up
Secondary	Plasma HIV RNA at baseline and during follow-up
Secondary	CD4 T cell and CD8 T cell HIV specific responses at baseline and after 12 months
Secondary	Change in lipodystrophy clinical score and quality of life during the follow-up
Secondary	Criteria to resume antiretroviral treatment: CD4T cell count below or equal to 300/mm3
Secondary	The occurrence of an AIDS defining event