Impact of Maraviroc on immune function

• Research type

  Research Study

• Full title

  A Randomised, Placebo Controlled, Phase IV, Safety and Exploratory Immunogenicity Study into the Impact of Maraviroc, an Orally Administered CCR5 Inhibitor, on the Intensification of Immune Function in HIV-1 Infected Subjects Receiving Immunisation with Novel Antigens.

• IRAS ID

  10097

• Sponsor organisation

  St Stephen's AIDS Trust

• Eudract number

  2008-006769-95

• ISRCTN Number

  not known

• Research summary

  HIV treatment involves using a combination of medicines because HIV infection can quickly adapt and become resistant to one single treatment. Maraviroc is an antiretroviral drug developed for treating HIV. This study aims to evaluate its impact on immune function. 92 HIV-1 infected adults who are currently on a stable HIV medication regime and who have been immunised with tetanus in the past or are known to have tetanus antibodies in their blood will be randomly assigned to one of two treatment groups (46 in each): - one 150mg Maraviroc tablet twice dailyor- one Maraviroc placebo tablet twice dailyAll will continue their usual HIV medication. All participants will receive three vaccinations (cholera, tetanus toxoid and meningococcal vaccines) and a skin test (Mantoux skin test) used to identify patients previously infected with the tuberculosis bacterium. This study will look at the effect of Maraviroc on patient response to these vaccinations and the skin test. This study is double blind, meaning that neither the participant nor the study doctor will know whether they/the participant's receiving Maraviroc or placebo.There is also an optional sub-study, for 20 participants, which will look at the impact of Maraviroc on mucosal immune function. In order to do this the participant will be asked to donate a sample of tissue from the lining of the intestine at the start and end of the study in a procedure called an endoscopic biopsy. This is a single centre study with a treatment period of 24 weeks (plus a screening period up to 4 weeks prior to the start of the study). Participants will be asked to visit the clinic 8 times for the duration of this trial (consisting of screening visit, baseline visit and then 4, 12, 16 and 24 weeks after baseline).

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  08/H0711/116

• Date of REC Opinion

  5 Mar 2009

• REC opinion

  Further Information Favourable Opinion