Effect of Atazanavir-ritonavir on the Pharmacokinetics and Toxicity of Lumefantrine

• Status: Completed
• Trial end date: 2019-08-15
• Target enrollment: 0
• Participant gender: All

Summary

A case control pharmacokinetic study evaluating the effects of atazanavir-ritonavir on the pharmacokinetics and toxicity of lumefantrine in people living with HIV attending APIN clinic of the Lagos University Teaching Hospital

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Fogarty International Center of the National Institute of Health
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS); National Institute on Minority Health and Health Disparities (NIMHD); NIH Office of AIDS Research (OAR)
• Treatments: Artemether; Artemether, Lumefantrine Drug Combination; Atazanavir Sulfate; Lumefantrine; Ritonavir

Criteria

Inclusion Criteria:

• Adult male or non-gravid female ≥18 years of age,

• Informed written consent,

• Malaria parasitaemia

• Axillary temperature ≥37.5°C or history of fever within 24 hours before visiting the clinic and with, at least, any of the following signs and symptoms of uncomplicated malaria: chills, sweats, headaches, muscle aches, nausea, vomiting, diarrhoea, body weakness, poor appetite and pallor.

• Hemoglobin (Hb) ≥8 g/dl

• Body weight ≥35 kg

• HIV positive (ATVr arm), HIV negative (AL/control arm)

Exclusion Criteria:

• Severe anaemia' (Haemoglobin levels < 8g/dl)

• Smokers/alcoholics and users of substances which inhibit or induce CYP3A4 iso enzymes

• Withdrawal of consent

• Known allergy to any of the study drugs

• Development of complications or severe adverse effects

• Smokers/alcoholics and users of caffeine, drugs which induce or inhibit CYP3A4 and CYP2B6

• Evidence of chronic illnesses such as diabetes, hypertension, psychiatric illnesses

• Subject taking any drugs or having any condition known to prolong QT-intervals

• Signs of severe malaria

• Use of anti-tubercular drugs for at least three months prior to enrolment

• Being on anti-malarial drugs within four weeks prior to enrolment

• Pregnant or nursing mother.