A Randomized Controlled Safety and Acceptability Trial of Dextrin Sulphate Vaginal Microbicide Gel in Sexually Active Women in Uganda
Date
2005-06-27
Authors
Journal Title
Journal ISSN
Volume Title
Publisher
Lippincott Williams & Wilkins
Abstract
Objective: To assess the safety of dextrin sulphate (DS) gel compared to placebo gel in terms of local and systemic adverse events, and to determine the acceptability of dextrin sulphate gel.
Design: A 4-week randomized trial of DS intra-vaginal gel, partially blinded, with placebo and observation control arms. Participants were randomized to use DS gel twice daily, placebo gel twice daily, DS gel pre-sex, or into an observation only arm.
Methods: Sexually active women were recruited from post natal and HIV clinics at Nsambya Hospital, Kampala, Uganda. Screening, enrolment and follow-up visits took place every 1 or 2 weeks over an 8-week period and consisted of questionnaire
interviews, colposcopy examinations, sexually transmitted infection screen and routine
laboratory testing.
Results: Out of a total of 172 women screened, 109 were randomized to use DS gel twice daily (65 women), placebo gel twice daily (15 women), DS gel pre-sex (nine women) or into an observation only arm (20 women). Two individuals had abnormal
colposcopy findings in the DS twice daily gel use arm. Vaginal bleeding was reported as frequently by participants in the active gel arm as by participants in the placebo and observation only arms. No clinically significant difference was observed between arms
in terms of vaginal flora, Candida, haemoglobin, white cell count, platelets, thrombin time, activated partial thromboplastin time, creatinine and aspartate aminotransferase results after 4 weeks of gel use. DS gel appeared to be acceptable to over 95% of the
users.
Conclusions: Results show a satisfactory safety and acceptability profile of dextrin sulphate gel.
Description
Keywords
Vaginal Microbicides, Condoms, Safety Studies, Acceptability Studies, Prevention of Sexual Transmission, Dextrin Sulphate
Citation
Bakobaki, J.M., Lacey, C.J., Bukenya, M.I., Nunn, A.J., McCormack, S., Byaruhanga, R.N., Okong, P., Namukwaya, S.W., Grosskurth, H. and Whitworth, J.A., 2005. A randomized controlled safety and acceptability trial of dextrin sulphate vaginal microbicide gel in sexually active women in Uganda. Aids, 19(18), pp.2149-2156.