Clinical trial NCT01019044: Exploration of HIV Reservoirs
Official title: Virologic and Immunologic Evaluation of the Deep Viral Reservoirs in HIV-1 Infected Patients With Long Term Viral Suppression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV-1 Infection
Keywords: HIV
Viral reservoirs
Viral load
Lead sponsor: Objectif Recherche Vaccins SIDA
Sponsor class: OTHER
First posted: 2009-11-25
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV-1 infected patients followed in specialized infectious disease/HIV hospital department

Brief summary: Prospective study in HIV-1 infected patients with a plasma viral load below the limit of detection and stable for at least 5 years.

Detailed description: Evaluation of the mucosal HIV reservoirs (HIV-DNA quantification and distribution of the infected T lymphocytes in the gut mucosa associated lymphoid tissue compared to the blood in HIV-1 infected patients under antiretroviral treatment with an undetectable plasma viral load below the 50 copies/ml limit of detection for at least 5 years).

Eligibility criteria: Inclusion Criteria:

* HIV-1 documented infection
* HIV-1 plasma viral load measurable before antiretroviral treatment initiation
* Patients treated with an antiretroviral combination containing a protease inhibitor and/or a non-nucleosidic reverse transcriptase inhibitor without any interruption since treatment initiation
* Patients with a stable plasma viral load below the limit of detection (HIV-RNA \< 50 copies/ml since January 2006 and/or HIV-RNA \< 200 copies/ml during the anterior period) under antiretroviral treatment for at least 5 years and for at least 90 % of the measures

Exclusion Criteria:

* Contraindication to the biopsy
* No ability or willingness to provide informed consent
* Concomitant treatment with antithrombotics or platelets antiaggregatory
* Patients co-infected with HCV and or HBV
* Patients who received an immunosuppressive treatment during 3 months prior enrollment (chemotherapy, radiotherapy, corticotherapy, splenectomy) or an immunotherapy during 5 years prior enrolment (IL-2, anti-HIV vaccine, IFN-alpha)

Primary outcomes:
measure: Quantification of the HIV-RNA plasma viral load using ultrasensible assay (limit of detection: 1 copy/ml)
timeFrame: Single patient visit
Secondary outcomes:
measure: Quantification of the HIV proviral DNA in the rectal mucosa biopsies and in the PPBMCs
timeFrame: Single patient visit
measure: Quantitative, phenotypic and functional description of the long-term immune reconstitution in the rectal mucosa biopsies
timeFrame: Single patient visit
measure: Quantification of HIV proviral DNA in the total CD4 lymphocytes
timeFrame: Single patient visit
measure: Pharmacokinetics of the antiretroviral molecules in the rectal mucosa biopsies and in the blood
timeFrame: Single patient visit
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Pitié-Salpêtrière
Study officials:
affiliation: Groupe Hospitalier Pitié-Salpêtrière
name: Christine KATLAMA, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: ORVACS
name: François LECARDONNEL, MSc
role: STUDY_DIRECTOR
References:
citation: Descours B, Lambert-Niclot S, Mory B, Samri A, Charlotte F, Peytavin G, Tubiana R, Papagno L, Bacchus C, Lecardonnel F, Katlama C, Autran B, Marcelin AG, Valantin MA, Carcelain G; DECAMUNE and ORVACS Study Groups. Direct quantification of cell-associated HIV DNA in isolated rectal and blood memory CD4 T cells revealed their similar and low infection levels in long-term treated HIV-infected patients. J Acquir Immune Defic Syndr. 2013 Mar 1;62(3):255-9. doi: 10.1097/QAI.0b013e318282537f.