Assessing the safety, pharmacokinetics and pharmacodynamics of single and 14 days dosing with two vaginal microbicide formulations containing either Darunavir, or Dapivirine and Darunavir.
- Conditions
- Topic: Infectious diseases and microbiologySubtopic: Infection (all Subtopics)Disease: Infectious diseases and microbiologyInfections and Infestations
- Registration Number
- ISRCTN23353517
- Lead Sponsor
- York Hospital NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 24
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:
10.1. Consistent use of condoms with every act of sexual intercourse
10.2. Combined oral contraceptive pill
10.3. Desogestrel containing progesterone only pill (Cerazette)
10.4. Intrauterine contraceptive device or system
10.5. Injectable contraceptive or progesterone implant
11. Willing to undergo a urinary pregnancy test at screening, on the day of randomisation, on the day of receipt of the second dose of the microbicide and at the final follow up visit
12. Have been registered with a General Practitioner (GP) for at least the past 3 months and willing to allow the investigators to discuss the volunteer’s medical history with their GP prior to randomisation
13. Agree to registration on a national database of trial subjects to prevent overvolunteering (TOPS), and to the taking of a photograph to be kept at the trial site
14. Upper Age Limit 50 years ; Lower Age Limit 18 years
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
10. Pregnant, less than 12 weeks postpartum, lactating or willingness/intention to become pregnant during the study
11. Significant concern raised by GP in relation to participation
12. Unable to read and speak English to a fluency level adequate for the full comprehension of procedures required inparticipation and consent
13. Unlikely to comply with the study protocol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Concentrations of IMP in secretions, plasma and tissue; Timepoint(s): 8 and 24 hours after a single dose,<br> 12 and 36 hours after 14 doses<br>
- Secondary Outcome Measures
Name Time Method