Patients Infected With HIV Since More Than 10 Years With a Plasma Viral RNA <400 Copies / mL in the Absence of Any Treatment: Study Mechanisms Involved in Controlling the Infection
Condition: HIV Infection
MeSH terms: Infections
Study type: Interventional

Summary: 
      The investigators have previously described a limited group of HIV-1-infected patients, we
      called HIV controllers (HIC), who have been infected for more than 10 years, in whom viral
      replication is spontaneously controlled without any treatment. These patients are defined
      according to virological criteria: more than 90% of the quantifications of plasma viral load
      should be less than 400 RNA copies/mL. The purpose of the ANRS EP36 study was to characterize
      these patients.
    

Detailed description: 
      To study the virological and immunological features of these patients, a consortium of
      research teams has been set up. Several results were obtained (cf publications) : HIC are
      infected with replication-competent virus, HIV infects HIC CD4 T cells ex vivo but the CD8 T
      cells fully control this viral replication. This study led to set up a national observatory
      of the HICs. This observatory, set up from May 2006 to May 2008, has allowed to identify and
      include 86 HIC patients in France (about one hundred had been reported by the ANRS centers).
      When a patient is included, clinical data are collected and a biologic collection set up
      which can be used in genomic studies. The main characteristics of the patients included in
      the observatory are a median age at the diagnosis of HIV infection of 29 years (range 1-49),
      a median age at inclusion of 45 years [19-78], 42% are women, 87% are caucasians. The median
      year of HIV diagnosis is 1989 (1983-1999), so a median of 18 years of known HIV infection.
      The CD4 median between 1986 and 2008 is 762 CD4/mm3 [IQR:589-962], 3% of the 1368 measures
      are ≤ 350 /mm3; 23% patients have a CD4 T cell count < 500/mm3 and 6% < 350/mm3 at the
      inclusion consultation. The CD4 slope on this period shows a slow decrease estimated to -13
      [-15,-11] CD4/mm3 per year. Between 1989 and 2007, 2% of the viral loads measured were ≥ 1000
      RNA copies/mL. The viral load at inclusion is > 400 RNA copies/mL in 4%. Median viral DNA at
      the inclusion in the observatory is 1, 75 [1, 44-2, 07] log copies/millions PBMC.

      The transformation of the observatory in a cohort CO 18 has several goals. The first one is
      to allow the long-term follow-up of the HIV controllers. Epidemiological, clinical,
      virological, and immunological data will be collected. The outcome of these patients is a
      major question: some patients could loose their HIC status either because of a drop in their
      CD4 T cell counts to a level below 200/mm3 without major viral replication or because viral
      replication becomes detectable. To understand the mechanisms involved in the control of the
      viral replication in HIC implies to study the patients in whom the viral control is lost and
      to compare them to the HIC in whom the control is preserved. Therefore it is of major
      importance to follow the patients now included in the observatory during a prolonged time. To
      increase the frequency of loss of control, the patients in whom the virus is controlled for
      at least 5 years but for less than 10 years will be included to increase the diversity of the
      HICs. Clinical events as neoplasias will be collected. The genomic studies will be continued
      with the benefits of new inclusions and european collaborations will be developed. The
      question of the quality-of-life of the patients HIC will be studied.
    

Intervention name(s): blood test at day one
Intervention type(s): Biological
Intervention description(s): Epidemiological, clinical, virological, and immunological data will be collected.
Clinical events as neoplasia will be collected
Intervention model: Single Group Assignment
Masking: None (Open Label)