HIV Infections and Infestations
Conditions
Interventions
The participants will be randomly allocated to the following three vehicles for vaginal administration of monoclonal antibodies C2F5, C2G12 and C4E10:
Arm 1: Mabgel (high dose)
Arm 2: Mabgel (low do
Sponsors
York Hospitals NHS Foundation Trust (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Females 2. Aged >=18 and <=45 years 3. In good health as determined by medical history, physical examination and clinical judgement 4. Willing and able to give written informed consent 5. Available for the duration of the study 6. Willing to undergo screening for HIV, hepatitis B & C, and sexually transmitted infections 7. Willing to abstain from vaginal practices including receptive oral sex and sexual intercourse from 48 hours before the first dose of the study gel until after visit 5 8. If physiologically fertile, using a reliable method of contraception for the two to three menstrual cycles covering the pre-study, and study dosing periods (methods defined as one of: consistent use of condoms with every act of sexual intercourse; combined oral contraceptive pill; intra-uterine contraceptive device; injectable contraceptive; progesterone implant) 9. Willing to abstain from using any genital preparations, other than the study gel, during the period of gel administration until after visit 5 10. Willing to abstain from using tampons during the period of gel administration until after visit 5 11. Judged by clinician to be able, and likely, to comply with the procedures required as set out in the protocol 12. Have been registered with a GP for at least the past 3 months 13. Have access to a domestic refrigerator at home for the purposes of storing the study gel
Exclusion criteria
Exclusion criteria: 1. Untreated syphilis, gonorrhoea, trichomonas, chlamydia, Candida or bacterial vaginosis 2. Clinically significant (out of the normal range and deemed clinically significant by the Chief Investigator [CI]) haematological, biochemical, or coagulation assay abnormalities on screening 3. HIV infection, anti-HCV antibody positive, HbsAg positive 4. Abnormal findings on pelvic examination, deemed clinically significant by the CI 5. History of coagulation disorders 6. Significant current general medical illness 7. Irregular menstrual bleeding likely to cause vaginal bleeding during the dosing period as judged by the CI 8. Current participation, or participation within the last 2 months in another clinical trial 9. Treatment for cervical intraepithelial neoplasia (CIN) or other gynaecological instrumentation of the cervix within the past 3 months 10. Pregnant, within 12 weeks postpartum, or breast feeding 11. Unlikely to comply with protocol 12. Have any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives 13. Unable to fluently read and speak English to a level adequate for the full comprehension of procedures required in participation and consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Levels of MAbs in Weck-Cel vaginal secretions 1 and 8 hours post-1st dose and 1 and 8 hours post-12th dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. 8 hour post-1st dose and 8 hour post-12th dose cervico-vaginal lavage MAb levels 2. 8 hour post-1st dose and 8 hour post-12th dose MAb levels in self-sampled vaginal aspirate 3. 8 hour post-1st dose and 1 hour post-12th dose plasma MAb levels 4. Number of grade 3 or above genital adverse events during the dosing or follow-up period 5. Number of grade 3 or above other clinical or laboratory adverse events confirmed at examination or on repeat testing respectively during the dosing or follow-up period 6. Number of events attributable to the study gel leading to discontinuation of gel | — |
Countries
United Kingdom
Outcome results
None listed