Condition category
Infections and Infestations
Date applied
11/08/2005
Date assigned
15/09/2005
Last edited
25/05/2010
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

Mrs Julie Bakobaki

ORCID ID

Contact details

222 Euston Road
London
NW1 2DA
United Kingdom
+44 (0)20 7670 4896
jmb@ctu.mrc.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MIA-002 Version 3

Study information

Scientific title

Acronym

MIA: Microbicides Initiative in Africa

Study hypothesis

That PRO 2000/5 (P) gel in 0.5% and 2% formulations are as safe and acceptable for women to use as a vehicle placebo gel

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

Prevention

Patient information sheet

Condition

HIV-1

Intervention

Two active study products (0.5% and 2% PRO 2000/5 Gel [P]) and a matched vehicle placebo (Placebo Gel [P]) inserted intra-vaginally twice a day for 28 days

Intervention type

Drug

Phase

Phase II

Drug names

PRO 2000/5 gel

Primary outcome measures

The primary end-points are local and systemic safety parameters, namely:
1. Deep (any size) or extensive superficial (greater than or equal to 4 times the size of the tip of a 5 x 10 mm cotton-tipped swab) genital epithelial disruption visible on naked eye examination or colposcopy
2. The appearance of a coagulation abnormality which is considered clinically relevant by the local investigator/Trial Management Group

Secondary outcome measures

The secondary end-points are:
1. Grade 3 clinical or laboratory adverse event confirmed on examination or repeat testing respectively, thought to be possibly or probably related to gel
2. Grade 3 unexpected vaginal bleeding as reported at interview or on a diary card or recorded on examination
3. Grade 1 unexpected vaginal bleeding not due to menses
4. Acceptability of gel as assessed by a semi-structured questionnaire
5. Alterations in vaginal flora assessed by Nugent score performed on Gram-stained slides

Overall trial start date

11/06/2003

Overall trial end date

17/11/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. Healthy* women aged between 18 and 45
2. Sexually active and likely to remain so for the duration of the study at a minimum rate of twice per week
3. Willing to undergo a genital infection screen
4. Willing to undergo a human immunodeficiency virus (HIV) test**
5. Willing to accept health education about condoms and to be supplied with condoms to be used at every episode of sexual intercourse during the study, and has used condoms before
6. Able to give informed consent
7. Either HIV negative or HIV positive in a monogamous sexual relationship with another person who is also HIV positive and who will give his signed consent to say he has been informed and understands about the trial

* HIV-seropositive women will be eligible providing they fulfil all other criteria including exclusion 10, and have a primary partner who is also HIV-seropositive. Antiretroviral therapy is permitted provided it has been stable for 2 months prior to enrolment and is not expected to change during participation in the study
** Unnecessary if HIV-positivity documented in medical records at Nsambya Hospital

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

180

Participant exclusion criteria

1. Pregnant, wanting to become pregnant or within 6 weeks postpartum
2. Current genital tract epithelial ulceration/disruption
3. Untreated gonococcal, chlamydial, or trichomonal infection, syphilis or symptomatic bacterial vaginosis
4. Is HIV positive and in a sexual relationship with someone who is not HIV infected, who will not have an HIV test before the trial, and/or who will not sign a consent form for the trial
5. Abnormal (grade II) haematology, biochemistry
6. Cervical intraepithelial neoplasia (CIN) greater than or equal to CIN II within 3 months
7. Acute/subacute pelvic inflammatory disease
8. Clinical coagulation disorder
9. Latex allergy
10. Current, recent (within 2 weeks) or on-going ill health that necessitates drug treatment (other than prophylaxis) or attendance at hospital***
11. Post-coital or intermenstrual bleeding in the past 3 months
12. (If post-natal) Persistent abnormal vaginal discharge
13. No reported use of condoms between screening and enrolment
14. Having participated in another microbicide trial in previous 30 days
15. Considered unlikely to be able to comply with protocol

*** Except for HIV positive women from the HIV clinic, where the same exclusion applies without the phrase 'or ongoing'; women may enter the study following the initiation of appropriate treatment

Recruitment start date

11/06/2003

Recruitment end date

17/11/2004

Locations

Countries of recruitment

Uganda

Trial participating centre

222 Euston Road
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

Imperial College London (UK)

Sponsor details

St Mary's Campus
Clinical Trials Centre
Winston Churchill Wing
Winsland Mews
London
W2 1NY
United Kingdom

Sponsor type

University/education

Website

http://www.imperial.ac.uk

Funders

Funder type

Government

Funder name

The project was funded by the European Commission

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20444744

Publication citations

  1. Results

    Kamali A, Byomire H, Muwonge C, Bakobaki J, Rutterford C, Okong P, Profy A, Byaruhanga R, Namukwaya S, McCormack S, Grosskurth H, Nunn AJ, Lacey CJ, A randomised placebo-controlled safety and acceptability trial of PRO 2000 vaginal microbicide gel in sexually active women in Uganda., Sex Transm Infect, 2010, 86, 3, 222-226, doi: 10.1136/sti.2009.038372.

Additional files

Editorial Notes