HIV, Acquired Immunodeficiency Syndrome (AIDS) Infections and Infestations HIV, Acquired Immunodeficiency Syndrome (AIDS)
Conditions
Interventions
Female subjects will be randomised to receive Dextrin Sulphate or placebo gel
Sponsors
Medical Research Council (MRC) (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Female subjects inclusion: 1. Healthy sexually active women, aged between 18 and 45 years, with a regular male partner 2. Using a combined oral contraceptive pill (first pill within last two or next two days) 3. Willing to undergo a sexually transmitted disease (STD) screen 4. Willing to complete a daily diary 5. Willing to abstain from using any genital preparations, other than the study gel 6. Willing to abstain from using any aspirin-related drugs (NSAIDs) eg 'Neurofen', 'Anadin' 7. Written informed consent given 8. Male partner willing to use condoms for every episode of sexual intercourse. For those whose male partner wishes to participate in Part 2 of the study, an HIV antibody test will be required at visit 3. Male subjects inclusion: 1. Healthy man aged 18 years or more 2. Willing to undergo STD screen 3. Willing to complete daily diary 4. Willing to abstain from using any genital preparations 5. Willing to have an HIV antibody test 6. Given written informed consent
Exclusion criteria
Exclusion criteria: Female subjects exclusion: 1. Pregnancy 2. Breastfeeding 3. Within 12 weeks postpartum 4. Within 12 weeks of treatment of cervical intra-epithelial neoplasia (CIN) 5. Current use of an intravaginal preparation (e.g. tampons) 6. Past history of genital ulcerative disease 7. Current antibiotic or anticoagulant therapy 8. Chemotherapy or immunotherapy within the past three months 9. Known intolerance to heparin, dextrin sulphate or other anticoagulants 10. Current discomfort or pain during sexual intercourse 11. Post-coital bleeding in the past three months 12. Known HIV positive 13. Currently participating in another trial 14. Considered unsuitable for trial Male subjects exclusion: 1. Past history of genital ulcerative disease 2. Current antibiotic or anticoagulant therapy 3. Chemotherapy or immunotherapy within the past three months 4. Known intolerance to heparin, dextrin sulphate or other anticoagulants 5. Current discomfort or pain during sexual intercourse 6. Known HIV positive 7. Currently participating in another trial 8. Considered unsuitable for the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Genital epithelium disruption and systematic absorption | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
United Kingdom
Outcome results
None listed