MedTrace Logo

Dolutegravir Interactions With Artemisinin-based Combination Therapies

NCT02242799 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2016-10-05

No results posted yet for this study

Summary

Malaria and HIV are found in the same regions of the world and developing countries are most affected by both diseases. For malaria, new drugs have been introduced called ACTs. These drugs are effective against malaria but little is known about how the levels of these drugs in blood relate to how effective these drugs are. For HIV, a new drug has been developed called dolutegravir which has potential to be widely used in developing countries. This proposal will explore how dolutegravir affects the drug levels of these antimalarial drugs and vice versa. In total, 46 healthy volunteers will participate in this study.

Conditions

Interventions

DRUG

Dolutegravir 50mg od

Dolutegravir 50mg once daily will be given either alone or in combination, as specified

DRUG

Artemether-lumefantrine combination

Artemether-lumefantrine combination will be given both alone and in combination with Dolutegravir 50mg od in order to assess changes in PK

DRUG

Artesunate-amodiaquine

Artesunate-amodiaquine will be given alone or in combination with Dolutegravir 50mg od (in a parallel study design) in order to assess the potential interaction causing changes in PK parameters

Sponsors & Collaborators

  • ViiV Healthcare

    collaborator INDUSTRY

  • Makerere University

    collaborator OTHER

  • University of Liverpool

    lead OTHER

Principal Investigators

  • Mohammed Lamorde, PhD, MBChB · Infectious Diseases Institute

  • Saye H Khoo, FRCP, PhD · University of Liverpool

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • Uganda

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02242799 on ClinicalTrials.gov