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| A phase II, double blind, placebo controlled, randomised, single centre study to assess the safety, tolerability and acceptability of Dextrin-2 Sulphate gel in sexually active female subjects and their male sexual partners at low risk of Human Immunodeficiency Virus (HIV) infection |
| ISRCTN | ISRCTN92729667 |
| DOI | 10.1186/ISRCTN92729667 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | A phase II, double blind, placebo controlled, randomised, single centre study to assess the safety, tolerability and acceptability of Dextrin-2 Sulphate gel in sexually active female subjects and their male sexual partners at low risk of Human Immunodeficiency Virus (HIV) infection |
| Scientific title | |
| Acronym | SHIELD |
| Serial number at source | E164/40 |
| Study hypothesis | This phase II trial will investigate the safety and acceptability of 0.125% Dextrin Sulphate in healthy sexually active females. |
| Lay summary | |
| Ethics approval | Not provided at time of registration |
| Study design | Randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | HIV, Acquired Immunodeficiency Syndrome (AIDS) |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/12/1998 |
| Anticipated end date | 30/04/2000 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 117 |
| Interventions | Female subjects will be randomised to receive Dextrin Sulphate or placebo gel |
| Primary outcome measure(s) | Genital epithelium disruption and systematic absorption |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Medical Research Council (MRC) (UK) |
| Trial website | |
| Publications | 2002 results in http://www.ncbi.nlm.nih.gov/pubmed/12447009 |
| Contact name | Dr Naomi Low-Beer |
| Address |
Clinical Research Fellow
GU Medicine and Communicable Diseases Imperial College at St Mary's Praed Street |
| City/town | London |
| Zip/Postcode | W2 1NY |
| Country | United Kingdom |
| Sponsor | Medical Research Council (MRC) (UK) |
| Address | 20 Park Crescent |
| City/town | London |
| Zip/Postcode | W1B 1AL |
| Country | United Kingdom |
| Tel | +44 (0)20 7636 5422 |
| Fax | +44 (0)20 7436 6179 |
| clinical.trial@headoffice.mrc.ac.uk | |
| Sponsor website: | http://www.mrc.ac.uk |
| Date applied | 03/10/2000 |
| Last edited | 30/07/2009 |
| Date ISRCTN assigned | 03/10/2000 |
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