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
Protocol serial number	MIA-002 Version 3
Sponsor	Imperial College London (UK)
Funder	The project was funded by the European Commission

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	MIA: Microbicides Initiative in Africa
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	PRO 2000/5 gel
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	17/11/2004

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	45 Years
Sex	Female
Target sample size at registration	180
Key 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
Key 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
Date of first enrolment	11/06/2003
Date of final enrolment	17/11/2004

Locations

Countries of recruitment

United Kingdom
England
Uganda

Study participating centre

222 Euston Road

London
NW1 2DA
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not 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