Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 12:05 AM
NCT ID:
NCT02011958
Eligibility Criteria:
Inclusion Criteria:
* Confirmed HIV positive test (2 rapid diagnostics tests (RDTs) followed by a confirmatory ELISA test).
* Diagnosis of VL (first episode or relapse) confirmed by bone marrow or spleen aspirate.
* Male and female age: 18-60 years.
* Written informed consent from the patient.
Exclusion Criteria:
* Women of child-bearing potential (defined as women who have achieved menarche) who are not using an assured method of contraception or are unwilling to use an assured method of contraception for the duration of treatment and four months after.
* Pregnant women or breast-feeding mothers.
* Patients with grade 2 or 3 post kala-azar dermal leishmaniasis (PKDL) lesions.
* Clinical or biological evidence of severe cardiac, renal or hepatic impairment.
* Known hypersensitivity to AmBisome® and/or miltefosine.
* Patients receiving allopurinol treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02011958
Study Brief:
Protocol Section:
NCT02011958