NCT00118677

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 130 (planned)
• Sponsor: French National Agency for Research on AIDS and Viral Hepatitis · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• HIV Infections

Interventions

Type	Name	Description
PROCEDURE	Treatment interruption

Timeline

• Start date: 2003-02-01
• Completion: 2007-05-01
• First posted: 2005-07-12
• Last updated: 2007-08-30

Locations

1 site across 1 country: France