Long-Term Supervised Treatment Interruption in HIV-Infected Patients

Phase 3

Completed

• Conditions: HIV Infections

• Registration Number: NCT00118677
• Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis

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 Timeline

• Study Start: 2003-02
• Study First Submitted: 2005-07-01
• Study First Submitted QC: 2005-07-01
• Study First Posted: 2005-07-12
• Study Completion: 2007-05
• Status Verified: 2007-08
• Last Update Submitted: 2007-08-29
• Last Update Posted: 2007-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Service d'immunologie Clinique, Höpital Européen Georges Pompidou; 🇫🇷 Paris, France