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 | https://doi.org/10.1186/ISRCTN92729667 |
| Secondary identifying numbers | E164/40 |
- Submission date
- 03/10/2000
- Registration date
- 03/10/2000
- Last edited
- 30/07/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Naomi Low-Beer
Scientific
Scientific
Clinical Research Fellow
GU Medicine and Communicable Diseases
Imperial College at St Mary's
Praed Street
London
W2 1NY
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study acronym | SHIELD |
| Study objectives | This phase II trial will investigate the safety and acceptability of 0.125% Dextrin Sulphate in healthy sexually active females. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | HIV, Acquired Immunodeficiency Syndrome (AIDS) |
| Intervention | Female subjects will be randomised to receive Dextrin Sulphate or placebo gel |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | 0.125% Dextrin Sulphate |
| Primary outcome measure | Genital epithelium disruption and systematic absorption |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/12/1998 |
| Completion date | 30/04/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 117 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/12/1998 |
| Date of final enrolment | 30/04/2000 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Clinical Research Fellow
London
W2 1NY
United Kingdom
W2 1NY
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
| Phone | +44 (0)20 7636 5422 |
|---|---|
| clinical.trial@headoffice.mrc.ac.uk | |
| Website | http://www.mrc.ac.uk |
Funders
Funder type
Research council
Medical Research Council (MRC) (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2002 | Yes | No |
