• A randomized trial of AmBisome monotherapy and combination of AmBisome and miltefosine for the treatment of VL in HIV positive patients in Ethiopia followed by secondary VL prophylactic treatment with pentamidine

      Hailu, Asrat; Diro, Ermias; Kolja, Stille; Ritmeijer, Koert; Yifru, Sisay; Griensven, Johan van; Zijstra, Ed; Dorlo, Thomas; Strub-Wougaft, Nathalie; Bardonneau, Clelia; et al. (2018-07)
      General Objectives The overall objective of this trial is to identify a safe and effective treatment for VL in HIV coinfected patients. Primary Objective: To evaluate at day 29 assessment the efficacy of a combination regimen of AmBisome® + miltefosine and AmBisome® monotherapy in Ethiopian co-infected HIV + VL patients. Secondary Objectives: 1. To evaluate relapse-free survival at day 390 (after initial cure at day 29 or cure at day 58 after extended treatment). 2. To assess safety of the regimens. Other objectives: 1.To evaluate of viral load and CD4 count in all patients 2. To evaluate the pharmacokinetics of ARV, Ambisome and miltefosine and immune function markers in a subset of patients
    • Secondary prophylaxis of visceral leishmaniasis relapses in HIV co-infected patients using pentamidine as a prophylactic agent: a prospective cohort study

      Diro, Ermias; Griensven, Johan van; Woldegebreal, Teklu; Belew, Zewdu; Taye, Melese; Yifru, Sisay; Davidson, Robert N.; Balasegaram, Manica; Lynen, Lut; Boelaert, Marleen; et al. (2018-07)
      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