Skip to content
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Menu
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Menu
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Microbicides Development Programme: Design of a phase III trial to measure the efficacy of the vaginal microbicide PRO 2000/5 for HIV prevention
Trials, Volume 10, Article 99, Year 2009
Notification
URL copied to clipboard!
Description
Background: With 2.5 million new HIV infections per year, effective preventive methods against HIV are urgently needed, especially in sub-Saharan Africa. MDP301 is an ongoing trial of the vaginal microbicide PRO 2000/5 being conducted by the Microbicides Development Programme. The main objective of the trial is to determine the efficacy and safety of 0.5% and 2% concentrations of PRO 2000/5 gel compared to placebo in preventing vaginally acquired HIV infection. Methods/Design: MDP301 is a multicentre randomised placebo-controlled Phase III trial. The design was informed by pre-trial feasibility and pilot studies. The choice of trial population, assessments and endpoints are discussed along with statistical and ethical considerations. Adaptations to the design were made during the conduct of the trial; these included closing a study arm and changing the timing of the primary endpoint. Discussion: The development of effective microbicide products remains one of the strongest hopes for new biomedical prevention tools. MDP301 is the largest Phase III microbicide trial to date, with 9404 enrolments, and is scheduled for completion in September 2009. Results are expected towards the end of 2009. Trial registration: Current controlled trials ISRCTN64716212. © 2009 Nunn et al; licensee BioMed Central Ltd.
Authors & Co-Authors
Nunn, Andrew J.
United Kingdom, London
Mrc Clinical Trials Unit
McCormack, Sheena Mary G.
United Kingdom, London
Mrc Clinical Trials Unit
Crook, Angela M.
United Kingdom, London
Mrc Clinical Trials Unit
Pool, Robert C.
Spain, Barcelona
Universitat de Barcelona
Rutterford, Clare M.
United Kingdom, London
Queen Mary University of London
Hayes, Richard John
United Kingdom, London
London School of Hygiene & Tropical Medicine
Statistics
Citations: 60
Authors: 6
Affiliations: 4
Identifiers
Doi:
10.1186/1745-6215-10-99
ISSN:
17456215
Research Areas
Infectious Diseases
Study Design
Cross Sectional Study