AEGiS-11IAC: Randomized, double-blind, placebo-controlled clinical trial of erythromycin and ciprofloxacin in the treatment of chancroid.

11th International AIDS Conference

Vancouver, British Columbia — July 7-12, 1996

Randomized, double-blind, placebo-controlled clinical trial of erythromycin and ciprofloxacin in the treatment of chancroid.

Int Conf AIDS 1996 Jul 7-12; 11:219 (abstract no. Th.B.111)
Malonza I, Tyndall M, Hawken M, Bukusi E, MacDonald K, Maclean I, Perriens J, Ronald AR, Ndinya-Achola JO, Moses S; Department of Medical Microbiology, University of Nairobi, Nairobi, Kenya, East Africa. Fax: 254-2-712007. E-mail: plummer@bldgHSC.Lan1.Umanitoba.CA.

Background and

OBJECTIVES: It is now recognized that HIV transmission can be reduced through the control of other STDs, particularly those which cause genital ulceration. However, there are limited data available on effective treatment for chancroid. In particular, the efficacy of single-dose regimens has not been well studied, and the response to treatment in HIV-positive individuals is controversial. The main objectives of this study therefore are to determine the efficacy and safety of two WHO-recommended drug regimens in HIV-infected and uninfected individuals.

METHODS: Men and women with clinically suspected chancroid presenting to the Special Treatment Clinic in Nairobi, Kenya, are randomized to receive either oral erythromycin, 500 mg. tid for 7 days, or oral ciprofloxacin, 500 mg. in a single dose. Drug administration is double blind and placebo-controlled. Patients are followed weekly until cured, and those failing initial treatment are given the second regimen, also in a double-blind fashion. Cure is defined as a fully healed ulcer. The planned sample size is 250 patients in each group. We report now on the first 49 patients.

RESULTS: Of the first 49 patients, the mean age was 28.6 years, 80% were male and 27% were HIV seropositive. Thus far, 9 (18%) have been lost to follow-up, 36 cured on initial treatment (90% of those followed), and 4 cured on second regimen (10% of those followed). Of the 36 patients cured on initial treatment, 16 (44%) were cured by the first week visit, 14 (39%) by the second week visit and the remaining 6 (17%) by the third week visit. Of the 4 patients who failed initial treatment, only 1 had a positive H. ducreyi culture and 3 had positive studies for syphilis. The laboratory etiological diagnoses were: H. ducreyi (HD) 53%; T. pallidum (TP) 41%; H. simplex (HSV) 16%; mixed HD/TP 10%; mixed HD/HSV 4%; mixed HD/TP/HSV 2%; and no discernable etiology 8%.

CONCLUSIONS: Thus far there have been very few treatment failures, particularly among cases of laboratory-confirmed chancroid, suggesting that both regimens may be effective. Further data evaluating a larger sample will be presented.

Keywords: AEGIS, Chancroid, Double-Blind Method, Erythromycin, Ciprofloxacin, Single-Blind Method, Placebos, Randomized Controlled Trials, Antibiotics, Macrolide, Anti-Infective Agents, Fluoroquinolone, HIV Infections, Syphilis, HIV, Ulcer, HIV Seropositivity, Treatment Failure, Kenya, Human, Female, Male, therapy, drug therapy, ICA11

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