Phase I study to assess pharmacokinetics of a candidate microbicide

• Research type

  Research Study

• Full title

  A randomised double blind phase 1 study to assess the pharmacokinetics of C2F5, C2G12 & C4E10 when administered together in a gel vehicle as a vaginal microbicide

• Contact name

  Georgina Morris

• Sponsor organisation

  York Hospitals NHS Foundation Trust

• Eudract number

  2008-000312-32

• ISRCTN Number

  n.a

• Clinicaltrials.gov Identifier

  n.a

• Research summary

  Vaginal microbicides are being developed as products to prevent HIV transmission. These products are designed to be applied intravaginally prior to sexual intercourse, and could provide women with a female-controlled HIV prevention method. The aim of this study is to assess the safety of a microbicide gel (??MABGEL??) containing 3 antibodies (C2F5, C2G12 & C4E10) when used in the vagina every day for 12 days. The antibodies used in the study gel have previously been given to humans intravenously and have been shown to be safe and well-tolerated. We do not expect there to be any serious adverse events caused by the study gel.Participation in the study will last approximately 6 to 8 weeks. We will recruit 30 healthy female volunteers, aged 18 to 45 years old. Participants will attend York Hospital for a screening visit. After giving their informed consent, they will have a medical examination including an internal vaginal examination. Blood and vaginal samples will be taken to screen for STIs and other abnormalities. If a participant's found to be healthy, after fully informed consent, they will enter the dosing stage of the study. Participants will be randomly assigned to receive either the gel containing the active ingredient, or a placebo gel. The participant will see a doctor or nurse who will administer the study gel for them. They will return for two more visits that day, and then administer the remaining 11 doses of the gel at home. The participant will attend for a visit once during the period when they are using the study gel and a further three times after completing all doses. At all of these visits, the participant will have vaginal examinations and they will provide blood and/or vaginal samples

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  08/H0304/87

• Date of REC Opinion

  23 Oct 2008

• REC opinion

  Further Information Favourable Opinion