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Bukenya Michael*
Julie Pickering*, Stella Mukwaya*,Romano Byaruhanga**, Charles Lacey***, Jimmy Whitworth*, and Pius Okong**
*Medical Research Councl Programme on AIDS in Uganda, **St Francis Hospital Nsamby, Uganda, ***Imperial College, London.
Background
We perfomed a randomised placebo controlled trial to assess safety of 4% intravaginal dextrin sulphate gelat a hospital in Kampala, Uganda.
Methods
Sexually active females of reproductive age were screened for eligibility of the study. Those found to have sexually transmitted infections were treated before entry. Consentig females were allocated toactive gel or its matched vehicle placebo, pre sex active gel and observation only arm. Total follow up lasted 8 weeks during which women were interviewed, examined by colposcopy and labaratory tests(HIV test, STD screening, haematology, coagulation and clinical chemistry ) perfomed.
Results
A total of 109 females were enrolled(71 HIV negative & 38HIV positive); 80 to use gel twice a day[65active gel, 15 placebo], 9 active gel pre sex and 20 observation only arm. In 7/322(2.2%) colposcopy exams, abnormalities were documented among females using active gel, and in 11/74(14.9%)within the placebo group. Only 2 of the 18 abnormalities were thought to be gel related. 6/65(9%) participants on active gel twice daily reported mild intermenstrual spotting, compared to 2/15(13%) using placebo, and 3/20(15%) using no gel. 8/65(12%) participants on active gel reported excessive thirst during the first week of gel use. No excess genital irritation, no evidence of change in vaginal flora, no evidence of systemic toxicity were observed as a result of gel use.
Conclusion
The results indicate a satisfactory safety profile of dextrin sulphate 4% gel in sexually active African population. In particular colposcopic abnormalities did not appear more frequent in the active gel arm. Temporary occurrence of excessive thirst may require further research.
Michael Bukenya
medical research council p.o. box 49 Entebbe
(Telephone) 031 262910 (E-mail) michael.bukenya@mrcuganda.org
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