Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
E164/40
Study information
Scientific title
Acronym
SHIELD
Study hypothesis
This phase II trial will investigate the safety and acceptability of 0.125% Dextrin Sulphate in healthy sexually active females.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
HIV, Acquired Immunodeficiency Syndrome (AIDS)
Intervention
Female subjects will be randomised to receive Dextrin Sulphate or placebo gel
Intervention type
Drug
Phase
Phase II
Drug names
0.125% Dextrin Sulphate
Primary outcome measure
Genital epithelium disruption and systematic absorption
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/12/1998
Overall trial end date
30/04/2000
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
117
Participant 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
Recruitment start date
01/12/1998
Recruitment end date
30/04/2000
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Clinical Research Fellow
London
W2 1NY
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2002 results in http://www.ncbi.nlm.nih.gov/pubmed/12447009
Publication citations
-
Results
Low-Beer N, Gabe R, McCormack S, Kitchen VS, Lacey CJ, Nunn AJ, Dextrin sulfate as a vaginal microbicide: randomized, double-blind, placebo-controlled trial including healthy female volunteers and their male partners., J. Acquir. Immune Defic. Syndr., 2002, 31, 4, 391-398.