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) infectio
- Conditions
- Infections and InfestationsHIV, Acquired Immunodeficiency Syndrome (AIDS)
- Registration Number
- ISRCTN92729667
- Lead Sponsor
- Medical Research Council (MRC) (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 117
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Genital epithelium disruption and systematic absorption
- Secondary Outcome Measures
Name Time Method ot provided at time of registration