Plain English Summary
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
Null Hypothesis: That there is no difference in aquisition of HIV and sexually transmitted infections (STIs) in women using Pro2000 and placebo gel.
Not provided at time of registration
International multi-centre randomised double-blind placebo-controlled trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Pro 2000/5 (P) 0.5% and 2% gels, Placebo gel
Primary outcome measures
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 measures
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
Overall trial start date
Overall trial end date
Participant inclusion criteria
Participants will be sexually active, HIV negative healthy women who are not pregnant.
Target number of participants
Participant 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
Recruitment start date
Recruitment end date
Countries of recruitment
South Africa, Tanzania, Uganda, United Kingdom, Zambia
Trial participating centre
MRC Clinical Trials Unit
Department for International Development
Department for International Development, UK, DFID
Funding Body Type
Funding Body Subtype
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
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
9. 2015 results in http://www.ncbi.nlm.nih.gov/pubmed/26259895
10. 2015 results in http://www.ncbi.nlm.nih.gov/pubmed/25227554
11. 2015 results in http://www.ncbi.nlm.nih.gov/pubmed/25488170
Nunn A, McCormack S, Crook AM, Pool R, Rutterford C, Hayes R, Microbicides Development Programme: design of a phase III trial to measure the efficacy of the vaginal microbicide PRO 2000/5 for HIV prevention., Trials, 2009, 10, 99, doi: 10.1186/1745-6215-10-99.
Vallely A, Shagi C, Lees S, Shapiro K, Masanja J, Nikolau L, Kazimoto J, Soteli S, Moffat C, Changalucha J, McCormack S, Hayes RJ, Microbicides development programme: engaging the community in the standard of care debate in a vaginal microbicide trial in Mwanza, Tanzania., BMC Med Ethics, 2009, 10, 17, doi: 10.1186/1472-6939-10-17.
Informed consent results
Vallely A, Lees S, Shagi C, Kasindi S, Soteli S, Kavit N, Vallely L, McCormack S, Pool R, Hayes RJ, , How informed is consent in vulnerable populations? Experience using a continuous consent process during the MDP301 vaginal microbicide trial in Mwanza, Tanzania., BMC Med Ethics, 2010, 11, 10, doi: 10.1186/1472-6939-11-10.
Vaginal gel results
McCormack S, Ramjee G, Kamali A, Rees H, Crook AM, Gafos M, Jentsch U, Pool R, Chisembele M, Kapiga S, Mutemwa R, Vallely A, Palanee T, Sookrajh Y, Lacey CJ, Darbyshire J, Grosskurth H, Profy A, Nunn A, Hayes R, Weber J, PRO2000 vaginal gel for prevention of HIV-1 infection (Microbicides Development Programme 301): a phase 3, randomised, double-blind, parallel-group trial., Lancet, 2010, 376, 9749, 1329-1337, doi: 10.1016/S0140-6736(10)61086-0.
Participant response results
Gafos M, Mzimela M, Ndlovu H, Mhlongo N, Hoogland Y, Mutemwa R, "One teabag is better than four": Participants response to the discontinuation of 2% PRO2000/5 microbicide gel in KwaZulu-Natal, South Africa., PLoS ONE, 2011, 6, 1, e14577, doi: 10.1371/journal.pone.0014577.
Effects of injectable hormonal contraceptives
Wand H, Ramjee G, The effects of injectable hormonal contraceptives on HIV seroconversion and on sexually transmitted infections., AIDS, 2012, 26, 3, 375-380, doi: 10.1097/QAD.0b013e32834f990f.
Abaasa A, Crook A, Gafos M, Anywaine Z, Levin J, Wandiembe S, Nanoo A, Nunn A, McCormack S, Hayes R, Kamali A, Long-term consistent use of a vaginal microbicide gel among HIV-1 sero-discordant couples in a phase III clinical trial (MDP 301) in rural south-west Uganda., Trials, 2013, 14, 33, doi: 10.1186/1745-6215-14-33.
Jentsch U, Lunga P, Lacey C, Weber J, Cairns J, Pinheiro G, Joseph S, Stevens W, McCormack S, The implementation and appraisal of a novel confirmatory HIV-1 testing algorithm in the Microbicides Development Programme 301 Trial (MDP301)., PLoS ONE, 2012, 7, 9, e42322, doi: 10.1371/journal.pone.0042322.
Moodley J, Naidoo S, Wand H, Ramjee G; and the Microbicides Development Programme team, Contraception use and impact on pregnancy prevention in women participating in an HIV prevention trial in South Africa, J Fam Plann Reprod Health Care, 2015, doi: 10.1136/jfprhc-2014-101100.
Sookrajh Y1, Naidoo S1, Ramjee G2; MDP Team, Shared responsibility for ensuring appropriate management of incidental findings: a case study from South Africa, J Med Ethics, 2015 , 41, 3, 281-283, doi: 10.1136/medethics-2013-101561.
Gafos M, Pool R, Mzimela MA, Ndlovu HB, McCormack S, Elford J; MDP Team, Communication About Microbicide Use Between Couples in KwaZulu-Natal, South Africa, AIDS Behav, 2015 , 19, 5, 832-846, doi: 10.1007/s10461-014-0965-y.