Secondary prophylaxis of visceral leishmaniasis relapses in HIV co-infected patients using pentamidine as a prophylactic agent: a prospective cohort study

Abstract

2.1 OBJECTIVES 2.1.1 General objective: To document the effectiveness, safety and feasibility of monthly PM secondary prophylaxis (PSP) in VL/HIV co-infected patients that have documented parasite clearance after VL treatment when used for prevention of VL relapse. 2.1.2 Specific objectives of the primary study period 2.1.2.1 Primary objectives In VL/HIV co-infected patients that have documented parasite clearance after VL treatment: - to assess the effectiveness of PSP in terms of preventing relapse and death; - to assess the safety of PSP in terms of drug-related serious adverse events or permanent drug discontinuations due to adverse events; - to assess the feasibility of PSP in terms of number of patients compliant to therapy during the first year of monthly PM secondary prophylaxis. 2.1.2.2 Secondary objectives; In VL/HIV co-infected patients that have documented parasite clearance after VL treatment: - to assess the safety of PSP in terms of: - drug-related non-serious adverse events - serious adverse events (drug-related or not) - to assess the feasibility of PSP in terms of: - number of treatment interruptions/discontinuations, - number of therapeutic interventions needed to treat adverse drug reactions