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An international multi-centre, randomised, double-blind, placebo controlled trial to evaluate the efficacy and safety of 0.5% and 2% Pro 2000/5 gels for the prevention of vaginally acquired human immunodeficiency virus (HIV) infections
ISRCTN ISRCTN64716212
DOI 10.1186/ISRCTN64716212
ClinicalTrials.gov identifier NCT00262106
EudraCT number
Public title An international multi-centre, randomised, double-blind, placebo controlled trial to evaluate the efficacy and safety of 0.5% and 2% Pro 2000/5 gels for the prevention of vaginally acquired human immunodeficiency virus (HIV) infections
Scientific title
Acronym MDP301
Serial number at source MDP301
Study hypothesis Null Hypothesis: That there is no difference in aquisition of HIV and sexually transmitted infections (STIs) in women using Pro2000 and placebo gel.
Lay summary http://www.ctu.mrc.ac.uk/research_areas/study_details.aspx?s=16
Ethics approval Not provided at time of registration
Study design International multi-centre randomised double-blind placebo controlled trial
Countries of recruitment South Africa, Tanzania, Uganda, United Kingdom, Zambia
Disease/condition/study domain HIV
Participants - inclusion criteria Participants will be sexually active, HIV negative healthy women who are not pregnant.
Participants - exclusion criteria 1. Unable or unwilling to provide a reliable method of contact for the field team
2. Likely to move permanently out of the area within the next year
3. Likely to have sex more than 14 times a week on a regular basis during the course of follow-up
4. Using spermicides regularly
5. Pregnant or within 6 weeks postpartum at enrolment
6. Has grade 3 clinical or laboratory abnormalities which are considered by the clinician or the Trial Management Group to make enrolment inadvisable
7. Requiring referral for assessment of a clinically suspicious cervical lesion
8. Treatment to the cervix, or to the womb through the cervix, within 30 days of enrolment
9. Known latex allergy
10. Participating, or having participated within 30 days of enrolment, in a clinical trial of an unlicensed product, microbicide, barrier method or any other intervention likely to impact on the outcome of this trial
11. Considered unlikely to be able to comply with the protocol
Anticipated start date 01/08/2005
Anticipated end date 31/03/2009
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 9,673
Interventions Pro 2000/5 (P) 0.5% and 2% gels, Placebo gel
Primary outcome measure(s) 1. Acquisition of HIV infection before or at the 9 month time point, confirmed by a Central Reference Laboratory, in participants confirmed to be HIV negative at enrolment
2. Grade 3 (severe) or 4 (life-threatening) clinical events noted through systematically solicited questions, or laboratory adverse events confirmed on examination or repeat testing respectively
Secondary outcome measure(s) 1. Acquisition of HIV infection before or at the 6 and 12 month time points, confirmed by a Central Reference Laboratory, in participants confirmed to be HIV negative at enrolment
2. Acquisition of herpes simplex virus type 2 (HSV-2) in women uninfected at enrolment
3. The point prevalence of Neisseria gonorrhoeae (NG) or Chlamydia trachomatis (CT) after 24 weeks of follow-up, determined by a positive nucleic acid amplification assay
4. All systematically solicited genital adverse events
5. All clinical and laboratory adverse events
Sources of funding Department for International Development (DFID) (UK)
Trial website http://www.mdp.mrc.ac.uk
Publications 1. 2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19860888
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19814830
3. 2010 informed consent results in http://www.ncbi.nlm.nih.gov/pubmed/20540803
4. 2010 vaginal gel results in http://www.ncbi.nlm.nih.gov/pubmed/20851460
5. 2011 participant response results in http://www.ncbi.nlm.nih.gov/pubmed/21344002
6. 2012 effects of injectable hormonal contraceptives in http://www.ncbi.nlm.nih.gov/pubmed/22156970
7. 2012 substudy HIV-1 testing algorithm results in http://www.ncbi.nlm.nih.gov/pubmed/22984401
8. 2013 results in www.ncbi.nlm.nih.gov/pubmed/23374729
Contact name Dr  Sheena  McCormack
  Address MRC Clinical Trials Unit
222 Euston Rd
  City/town London
  Zip/Postcode NW1 2DA
  Country United Kingdom
Sponsor Medical Research Council (MRC) (UK)
  Address Ian Viney
MRC Centre London
Stephenson House
158-160 North Gower Street
  City/town London
  Zip/Postcode NW1 2DA
  Country United Kingdom
Date applied 03/05/2005
Last edited 07/02/2013
Date ISRCTN assigned 06/07/2005
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