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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20444744
Publication citations
-
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.