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.
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
- Marie Laga, Prince Leopold Institute for Tropical Medicine, STD/HIV
Research and Intervention Unit, Department of Microbiology, BE-Antwerp,
- Jan Balzarini, Katholieke Universiteit Leuven, Afdeling Virologie en
Chemotherapie – Faculteit Geneeskunde, Departement Microbiologie en Immunologie,
- Jag Whitworth, Uganda Virus Research Institute, Medical Research
Council Programme on Aids, Entebbe, Uganda
- Peter Ghys and I.M. Coulibaly, Programme National de Lutte
Contre Le Sida, Les MST et La Tuberculose, Abidjan, Ivory Coast