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Last Updated: 24/10/2014
Phase 2A Dose Escalation Study of the Efficacy, Safety and Pharmacokinetics of Low Single-Dose Primaquine for Gametocytocidal Activity against P. Falciparum in Sub-Saharan Africa
Objectives
The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of low
single-dose primaquine for gametocidal activity against P. falciparum among adult
glucose-6-phosphate dehydrogenase (G6PD)-normal malaria patients.
Specific objectives:
- To evaluate the efficacy of DP +SLD PQ vs DP + methylene Blue, VS SPAQ vs SPAQ + SLD PQ to prevent transmission of P. falciparum.
- Dose Adaptive trial of SLD-PQ safety in G6PD deficient Malian adults.
- Age de-escalation study of SLD-PQ dose in G6PD deficient Malian adolescents and children.
- Qualitative assessment to assess the readiness of Asian Pacific countries to roll out routine G6PD testing for the case management of P. vivax.
- Maintain momentum of the SLD PQ Roll Out group to deliver a therapeutic range of SLD PQ and support the availability of quality-assured SLD PQ in countries that want it.
Principal Institution
University of California San Francisco (UCSF), United States
Principal Investigators / Focal Persons
Rationale and Abstract
Outcome measures:
- Primary: mosquito infectivity assessed through membrane feeding
- Secondary: gametocyte prevalence and density, primaquine pharmacokinetics – area under the curve (AUC) of parent drug and metabolite, asexual parasite prevalence and density, safety measurements including haemoglobin and signs of hemolysis
NCT id: NCT02011555
Study Design
Phase II, interventional clinical trial
Thematic Categories
Date
Sep 2013 — Feb 2015
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