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	https://doi.org/10.1186/ISRCTN64716212
ClinicalTrials.gov number	NCT00262106
Secondary identifying numbers	MDP301

Submission date: 03/05/2005
Registration date: 06/07/2005
Last edited: 14/03/2017

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

Not provided at time of registration

Study website

Contact information

Dr Sheena McCormack
Scientific

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

Study information

Study design	International multi-centre randomised double-blind placebo-controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
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
Study 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(s)	Not provided at time of registration
Condition	HIV
Intervention	Pro 2000/5 (P) 0.5% and 2% gels, Placebo gel
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)
Primary outcome measure	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 study start date	01/08/2005
Overall study end date	31/03/2009

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Sex	Female
Target number of participants	9,673
Participant inclusion criteria	1. Sexually active 2. HIV-negative healthy women 3. Not pregnant
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

England
South Africa
Tanzania
Uganda
United Kingdom
Zambia

Study participating centre

MRC Clinical Trials Unit

London
NW1 2DA
United Kingdom

Sponsor information

Medical Research Council (MRC) (UK)
Research council

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

"ROR"	https://ror.org/03x94j517

Funders

Funder type

Government

Department for International Development
Government organisation / National government

Alternative name(s): Department for International Development, UK, DFID
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	results	09/10/2009	Yes	No
Protocol article	protocol	27/10/2009	Yes	No
Results article	informed consent results	13/06/2010	Yes	No
Results article	vaginal gel results	16/10/2010	Yes	No
Results article	participant response results	21/01/2011	Yes	No
Results article	substudy HIV-1 testing algorithm results	01/01/2012	Yes	No
Other publications	effects of injectable hormonal contraceptives	28/01/2012	Yes	No
Results article	results	01/02/2013	Yes	No
Results article	results	01/03/2015	Yes	No
Results article	results	01/05/2015	Yes	No
Results article	results	01/01/2016	Yes	No
Results article	results	01/01/2016	Yes	No
Results article	HSV-2 results	12/12/2016	Yes	No
Results article	results	11/03/2017	Yes	No

Editorial Notes

14/03/2017: Publication reference added.
16/02/2017: Publication reference added.
31/01/2017: Publication reference added.