Immunological Impact of HCQ-1; SSAT 039

• Research type

  Research Study

• Full title

  The immunological impact of adding hydroxychloroquine in patients with discordant CD4+ cell responses to suppressive HAART: A Phase I pilot study

• IRAS ID

  57970

• Contact name

  Laura Waters

• Sponsor organisation

  St Stephen's AIDS Trust

• Eudract number

  2010-020996-22

• ISRCTN Number

  n/a

• Research summary

  The Human Immunodeficiency Virus (HIV) attacks the body's immune system, which provides a natural defence system against disease and infection. The HIV virus can be spread through the exchange of bodily fluids, such as blood, semen, and vaginal fluids. There is no cure, or vaccine, for HIV infection. The introduction of suppressive combination antiretroviral therapy has revolutionised the treatment of HIV disease, leading to marked reductions in HIV related diseases and deaths. Suppressive combination antiretroviral therapy (cART) is usually associated with a rise in CD4 cell count. The CD4 cell is a white blood cell involved in the body’s immune response, a cell count is used as a marker for recovery of the immune system. However, a proportion of individuals, despite achieving HIV viral suppression, do not experience satisfactory recovery of their immune response system. A number of studies have shown that the risk of developing an ‘AIDS defining illness’ on suppressive cART is greater for subjects with reduced immunological recovery. Studies exploring changes in antiretrovirals or addition of antiretrovirals from new classes in patients with reduced immunological recovery have, in general, yielded disappointing results. Chronic HIV infection is characterised by gradual loss of CD4 cells. Increased immune activation is an indirect mechanism that is central to CD4 cell loss. The level of immune activation is associated with the rate of CD4 decline. Immune activation has also been shown to correlate with disease progression and survival. The purpose of this study is to examine the effects of adding a drug called hydroxychloroquine, to participants’ usual antiretroviral combination. Hydroxychloroquine works by inhibiting immune activation. Hydroxychloroquine has also been shown to inhibit HIV replication and promote CD4 immune protection. The study will primarily investigate the effect of adding this medication on immunological parameters (particularly CD4 count), on other safety parameters (such as cholesterol), participants’ side effects and participants’ viral load.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  10/H0806/78

• Date of REC Opinion

  15 Nov 2010

• REC opinion

  Further Information Favourable Opinion