Prophylaxis of Visceral Leishmaniasis Relapses in HIV Co-infected Patients With Pentamidine: a Cohort Study
Status:
Completed
Trial end date:
2015-11-01
Target enrollment:
Participant gender:
Summary
Visceral leishmaniosis (VL) is widely reported in Ethiopia, with about 30% of cases being
associated with human immunodeficiency virus (HIV). In absence of antiretroviral treatment
(ART), poor prognosis, high mortality and high relapse rates are characteristic of Ethiopian
VL patients with HIV co-infection. Conversely, co-infection can be successfully managed via a
combination of effective treatment of the initial episode, timely ART and prevention of
relapses.
Actually, until cellular immunity returns with ART, the patient is at risk of VL relapses,
which can result in death, severe illness, reduced ART efficacy, drug-resistance and possibly
transmission of drug-resistant Leishmania donovani. Patients most vulnerable to relapses are
those with high levels of immunosuppression, with previous VL episodes, or with opportunistic
infections (OIs). The most important factor to prevent relapses seems to be the clearance of
visible parasites.
Limited studies in Europe show that HIV co-infected patients may benefit from secondary
prevention with antimonials (part of mainstay treatment for VL in Ethiopia) and pentamidine
(PM), not used for VL treatment in Africa. Such maintenance treatment has not been studied in
African VL, but the poor outcomes without secondary prevention highlight a need of better
care to patients at risk of relapse.
This prospective cohort study aims at documenting the patient's outcomes of secondary
prophylaxis with PM in VL-HIV co-infection, in terms of time to relapse or death, safety and
feasibility, before it can be considered for general use in Ethiopia. A placebo group is not
included, due to the clear advantages of the intervention to the patient population.