Long-Term Supervised Treatment Interruption in HIV-Infected Patients

French National Agency for Research on AIDS and Viral Hepatitis

Status and phase: Completed; Phase 3

Conditions: HIV Infections

Treatments: Procedure: Treatment interruption

Study type: Interventional

Funder types: Other

Identifiers

NCT00118677

ANRS 116 SALTO

Details and patient eligibility

About

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.

Full 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).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)