Clinical trial NCT00118677: Long-Term Supervised Treatment Interruption in HIV-Infected Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: HIV Infections
Lead sponsor: French National Agency for Research on AIDS and Viral Hepatitis
Sponsor class: OTHER_GOV
First posted: 2005-07-12
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients who did not resume antiretroviral treatment at 12 months
Secondary outcomes:
measure: Time to resume antiretroviral treatment with CD4 cell count equal or below 300/mm3
measure: Proportion of patients who did not resume antiretroviral treatment at M 24 and M 36
measure: Predictive factors associated with the time of restart of antiretroviral therapy: Proviral HIV DNA at baseline and during follow-up
measure: Plasma HIV RNA at baseline and during follow-up
measure: CD4 T cell and CD8 T cell HIV specific responses at baseline and after 12 months
measure: Change in lipodystrophy clinical score and quality of life during the follow-up
measure: Criteria to resume antiretroviral treatment: CD4T cell count below or equal to 300/mm3
measure: The occurrence of an AIDS defining event
Other outcomes:
Locations:
city: Paris
country: France
facility: Service d'immunologie Clinique, Höpital Européen Georges Pompidou
Study officials:
affiliation: Hopital Georges Pompidou Paris France
name: Christophe Piketti, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Inserm U720
name: Dominique Costagliola
role: STUDY_CHAIR
References:
citation: 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.