R-PrEP Trial

• Research type

  Research Study

• Full title

  The time to protection and adherence requirements of Raltegravir with or without lamivudine in protection from HIV-1 infection

• IRAS ID

  202316

• Contact name

  Julie Fox

• Contact email

  julie.fox@kcl.ac.uk

• Sponsor organisation

  Guy's & St. Thomas' NHS Foundation Trust

• Eudract number

  2016-000437-43

• Duration of Study in the UK

  0 years, 7 months, 1 days

• Research summary

  This study evaluates whether a one week course of Raltegravir alone or in combination with lamivudine can prevent HIV from infecting genital tissue and relates this to the level of drug in the blood and genital tissue. 36 HIV negative individuals will be randomised to take Raltegravir alone or Raltegravir/lamivudine for one week. All individuals will have a genital tissue biopsy taken before they start antiretroviral therapy to confirm that it can be infected with HIV in the laboratory. They are then randomised to one of six groups to have blood and tissue samples taken a pre-determined number of days after starting ARV and once off ART. Tissue samples comprise the following: mouth swab, vaginal swab and biopsy (women only), rectal swab (men and women) and rectal biopsy (men and women). The individuals will then have a one month drug wash out period and then commence the second ARV regime and have genital tissue biopsies taken at a pre-stipulated day both on therapy and after stopping therapy. Individuals will attend 8 times over a 7-8 week period.
  All samples taken will be 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 profile of Raltegravir and lamivudine drug levels (in the mouth, blood, 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 and women). The results from the two drug regimes will be compared. Lamivudine is now a generic drug so expanding its use makes economic sense.

  Lay summary of study results: Raltegravir alone:
  - 70-80% protection achieved by day 2. Similar protection in vagina and rectum. Protection reducing after day 10
  Raltegravir/3TC:
  - Rectum: 100% protection from day 2 until day 8 then down to 80% thereafter
  - Vagina: 65% protection day 2. increasing to 100% protection at day 8
  - 3TC increases the level and longevity of protection in vagina and rectum
  Has the registry been updated to include summary results?: Yes
  If yes - please enter the URL to summary results: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fregister.clinicaltrials.gov%252Fprs%252Fbeta%252Fstudies%252FS00071P200000190%252Fresults%252FresultsSummary%2FNBTI%2FkeTAAQ%2FAQ%2F0d13317e-f32e-483e-8bff-110d4004ee59%2F3%2F58CjrpmgfT&data=05%7C02%7Csurreyborders.rec%40hra.nhs.uk%7C5660f6d74dc84a4d9aec08de124230f9%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638968272692923047%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=BhJ2tFuy6S9hZsj6Goddv3TH182kAUfmTFk8y671AQk%3D&reserved=0
  If no – why not?:
  Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: Yes
  If yes, describe or provide URLs to disseminated materials: The trial results were presented at a number of international conferences in in journal publications e.g J Antimicrob Chemother. 2021 Jul 15;76(8):2129-2136. doi: 10.1093/jac/dkab136.
  If pending, date when dissemination is expected:
  If no, explain why you didn't follow it:
  Have participants been informed of the results of the study?: Yes
  If yes, describe and/or provide URLs to materials shared and how they were shared: Summary results were circulated in recruiting clinics and among patient forums.
  If pending, date when feedback is expected:
  If no, explain why they haven't:
  Have you enabled sharing of study data with others?: Yes
  If yes, describe or provide URLs to how it has been shared: Analysed data can be shared by contacting the trial CI
  If no, explain why sharing hasn't been enabled:
  Have you enabled sharing of tissue samples and associated data with others?: Yes
  If yes, describe or provide a URL: Data generated from sample analysis can be obtained via contacting the trial CI
  If no, explain why: There were no residua
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• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  17/LO/0094

• Date of REC Opinion

  27 Jan 2017

• REC opinion

  Favourable Opinion