Condition category
Infections and Infestations
Date applied
03/10/2000
Date assigned
03/10/2000
Last edited
30/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Naomi Low-Beer

ORCID ID

Contact details

Clinical Research Fellow
GU Medicine and Communicable Diseases
Imperial College at St Mary's
Praed Street
London
W2 1NY
United Kingdom

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 measures

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

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 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Results - basic reporting

Publication summary

2002 results in http://www.ncbi.nlm.nih.gov/pubmed/12447009

Publication citations

  1. 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.

Additional files

Editorial Notes