Expand Access/Assess Safety and Efficacy of Paromomycin IM Injection for the Treatment of Visceral Leishmaniasis

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This modular Program will first confirm the safety and efficacy of Paromomycin IM Injection when given to an expanded population in the outpatient setting in experienced VL centers and subsequently evaluate the effectiveness of an expanded access model of providing Paromomycin IM Injection to progressively more resource-constrained clinics in Bihar, India.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PATH
• Treatments: Paromomycin

Criteria

Inclusion Criteria:

• Confirmed, newly diagnosed or relapsed visceral leishmaniasis

Exclusion Criteria:

• HIV infection, tuberculosis

• Significant hematologic, renal or liver dysfunction

• Malaria

• Those unable to be treated as an outpatient.