PrEP-investigating the role of Maraviroc 300mg in protection from HIV

• Research type

  Research Study

• Full title

  A phase IV study to determine the oral and genital tract concentration of Maraviroc required for ex vivo protection from HIV-1 using Maraviroc 300mg stat

• IRAS ID

  113495

• Contact name

  Alastair Teague

• Eudract number

  2012-003778-16

• Research summary

  This study evaluates whether a one-off dose of Maraviroc 300mg can prevent HIV from infecting genital tissue for the following 72-hour period and will relate this to the level of drug in the blood, mouth and genital tract. 54 HIV negative individuals will be randomised to take Maraviroc 300mg stat or not, and then to have blood and tissue samples taken a pre-determined number of hours later (up to 72 hours), dependent on randomization arm.  Tissue samples comprise the following: mouth swab, urethral swab (men only), vaginal swab and biopsy (women only), rectal swab (men and women) and rectal biopsy (men only). This process will take place on two occasions one month apart. Individuals will attend 6 times over a 4-6 week period. All samples taken will have drug levels measured and all vaginal and rectal samples will be assessed in the laboratory for how easily HIV can infect the tissue. This will provide a 72-hour profile of Maraviroc drug levels (in the mouth, blood urethra (in men), vagina (in women) and rectum (in men and women) and the degree of protection from HIV that this confers in the vagina (in women) and rectum (in men).

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  13/LO/0147

• Date of REC Opinion

  4 Apr 2013

• REC opinion

  Further Information Favourable Opinion