The objective of the project is the prevention of heterosexual transmission of HIV through the development and use of vaginal microbicides.
The goals of the project are:
1) To conduct and to publish the results of a Ugandan phase II, randomised, placebo-controlled study of the candidate microbicides Dextrin Sulphate and PRO 2000. The safety, tolerability and acceptability of these agents will be assessed in sexually active women attending St Francis Hospital, Nsambya, Kampala using the gels for a period of one month.[+] Read More
2) To determine the suitability of these vaginal microbicides for phase III studies. The safety and acceptability data from the successful completion of the placebo-controlled phase II safety study will enable the partners to select suitable agent(s) for phase III safety, tolerability and efficacity studies.
3) To prepare the African site for phase III studies of vaginal microbicides. The infrastructure of the developing country (DC) site will be prepared for phase III studies of vaginal microbicides by the transfer of technology, the development of local skills through workshops, the experience gained through conducting the phase II study and by the upgrading of local facilities.
4) To conduct a third part of a phase I study of Dextrin sulphate to explore the phenomenon of vaginal bleeding.
5) To conduct laboratory studies on cervico-vaginal lavages (CVLs) from a phase I study of Dextrin sulphate to evaluate cytokines and HIV-RNA.
Imperial College of Science, Technology and Medicine
Department of Genito-Urinary Medicine and Communicable Diseases
Imperial College School of Medicine at St Mary's, Norfolk Place
UK-W2 1PG London
Tel: +44 171 8861539
Fax: +44 171 8866645