MIA-002: A randomised, vaginal microbicide trial assessing the safety of PRO 2000/5 gel (P) versus vehicle placebo in Uganda

ISRCTN ISRCTN02518250
DOI https://doi.org/10.1186/ISRCTN02518250
Secondary identifying numbers MIA-002 Version 3
Submission date
11/08/2005
Registration date
15/09/2005
Last edited
25/05/2010
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

Mrs Julie Bakobaki
Scientific

222 Euston Road
London
NW1 2DA
United Kingdom

Phone +44 (0)20 7670 4896
Email jmb@ctu.mrc.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typePrevention
Scientific title
Study acronymMIA: Microbicides Initiative in Africa
Study objectivesThat 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedHIV-1
InterventionTwo 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 typeDrug
Pharmaceutical study type(s)
PhasePhase II
Drug / device / biological / vaccine name(s)PRO 2000/5 gel
Primary outcome measureThe 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 measuresThe 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 study start date11/06/2003
Completion date17/11/2004

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit45 Years
SexFemale
Target number of participants180
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment11/06/2003
Date of final enrolment17/11/2004

Locations

Countries of recruitment

  • England
  • Uganda
  • United Kingdom

Study participating centre

222 Euston Road
London
NW1 2DA
United Kingdom

Sponsor information

Imperial College London (UK)
University/education

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

Website http://www.imperial.ac.uk
ROR logo "ROR" https://ror.org/041kmwe10

Funders

Funder type

Government

The project was funded by the European Commission

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/06/2010 Yes No