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
Protocol serial number E164/40
Sponsor Medical Research Council (MRC) (UK)
Funder Medical Research Council (MRC) (UK)
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

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

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study acronymSHIELD
Study objectivesThis 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) studiedHIV, Acquired Immunodeficiency Syndrome (AIDS)
InterventionFemale subjects will be randomised to receive Dextrin Sulphate or placebo gel
Intervention typeDrug
PhasePhase II
Drug / device / biological / vaccine name(s)0.125% Dextrin Sulphate
Primary outcome measure(s)

Genital epithelium disruption and systematic absorption

Key secondary outcome measure(s)

Not provided at time of registration

Completion date30/04/2000

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target sample size at registration117
Key inclusion criteriaFemale 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 criteriaFemale 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 enrolment01/12/1998
Date of final enrolment30/04/2000

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Clinical Research Fellow
London
W2 1NY
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot 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
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