A randomised, double blind phase I study to assess the safety, pharmacokinetics and pharmacodynamics of single and 14 days dosing with two vaginal microbicide formulations containing either Darunavir, or Dapivirine and Darunavir.

York Hospital NHS Trust0 sites24 target enrollmentFebruary 5, 2015

Overview

No summary available.

Registry

who.int

Start Date

February 5, 2015

End Date

June 30, 2015

Last Updated

7 years ago

Study Type

Interventional

Sex

Female

Sponsor

York Hospital NHS Trust

•1\. Available for the duration of the study
•2\. Willing and able to give written informed consent
•3\. In good health as determined by medical history, physical examination, results of screening tests and the clinical judgment of a medically qualified investigator
•4\. Judged, in the opinion of a medically qualified investigator, to be able and likely to comply with all study requirements as set out in the protocol
•5\.Willing to undergo screening for HIV, Hepatitis B, Hepatitis C and sexually transmitted infections (Chlamydia, Gonorrhoea and Trichomonas)
•6\. Willing to abstain from vaginal practices including sexual intercourse and receptive oral sex from 48 hours before any given dose and up to 72 hours after
•7\. Willing to abstain from using any genital preparations other than the study gel during the period of gel administration and until the final follow up visit
•8\. Willing to abstain from using tampons during the two periods of gel administration
•9\. Willing to refrain from blood donation for the duration of the study
•10\. If fertile, using a reliable method of contraception for the 3 to 4 menstrual cycles covering the cycles pre study, during study dosing and until the final follow up visit has been completed. For the purposes of this trial only the following will be accepted as a reliable form of contraception:

•Untreated syphilis, gonorrhoea, trichomonas, chlamydia, vaginal candidosis or bacterial vaginosis (participants who test positive for any of these infections and are subsequently treated will be eligible provided all other inclusion criteria are met)
•1\. Seropositive for hepatitis B surface antigen (HBsAg) or Hepatitis C (antibodies to HCV) or HIV
•2\. Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis
•3\. Abnormal findings on pelvic examination, deemed clinically significant by a medically qualified investigator
•4\. Irregular menstrual bleeding likely to cause vaginal bleeding during the dosing period as judged by a medically qualified investigator
•5\. Treatment for CIN or other gynaecological instrumentation of the cervix within the last 3 months
•6\. An allergy to parabens or any of the other IMP constituents
•7\. Insertion of an intrauterine contraceptive device or system within the last 6 weeks
•8\. Any other significant disease, disorder or finding, which, in the opinion of a medically qualified investigator, may either put the volunteer at risk because of participation in the study, or may influence the result of the study, or the volunteer’s ability to participate in the study
•9\. Participation in another research study involving an investigational product in the 3 months preceding enrollment, or planned use during the study period