Condition category
Infections and Infestations
Date applied
03/05/2005
Date assigned
06/07/2005
Last edited
12/01/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Sheena McCormack

ORCID ID

Contact details

MRC Clinical Trials Unit
222 Euston Rd
London
NW1 2DA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00262106

Protocol/serial number

MDP301

Study information

Scientific 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

Acronym

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.

Ethics approval

Not provided at time of registration

Study design

International multi-centre randomised double-blind placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

HIV

Intervention

Pro 2000/5 (P) 0.5% and 2% gels, Placebo gel

Intervention type

Drug

Phase

Not Applicable

Drug names

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

01/08/2005

Overall trial end date

31/03/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Participants will be sexually active, HIV negative healthy women who are not pregnant.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

9,673

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

01/08/2005

Recruitment end date

31/03/2009

Locations

Countries of recruitment

South Africa, Tanzania, Uganda, United Kingdom, Zambia

Trial participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

Medical Research Council (MRC) (UK)

Sponsor details

Ian Viney
MRC Centre London
Stephenson House
158-160 North Gower Street
London
NW1 2DA
United Kingdom

Sponsor type

Research council

Website

Funders

Funder type

Government

Funder name

Department for International Development

Alternative name(s)

Department for International Development, UK, DFID

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

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

Publication summary

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

Publication citations

  1. Protocol

    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.

  2. Results

    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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Results

    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.

  8. 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.

  9. Results

    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.

  10. Results

    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.

  11. Results

    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.

Additional files

Editorial Notes