Lopinavir/r/ Lamivudine/ Abacavir as an Easy to Use Paediatric Formulation

Summary

A phase I/II, open label, randomized crossover pharmacokinetic, safety and acceptability study of the Abacavir/Lamivudine/ Lopinavir/Ritonavir (30/15/ 40/10mg ;4-in-1) Fixed-Dose Combination vs. Lopinavir/Ritonavir (40/10mg pellets) plus dual Abacavir/Lamivudine (60/30mg tablets) in HIV infected Children.

The study is intended to support the adoption of the 4-in-1 by healthcare providers and will provide data that may support its registration in certain countries. The study will be carried out in HIV-infected children in Uganda weighing 3 to 25 kg (inclusive) and unable to swallow tablets and will provide supportive clinical data on the pharmacokinetics, safety, tolerability and acceptability of the 4-in-1.

Conditions

• HIV

Interventions

DRUG

ABC/3TC/LPV/r granules (30/15/40/10 mgs)

This is a fixed dose combination. Each capsule contains Lopinavir (40mg), Ritonavir (10mg), Abacavir (30mg) and Lamivudine (15mg) in granules formulation. Dosage according to patient's weight: Between 3 and 5.9kg: 2 capsules twice a day Between 6 and 9.9kg: 3 capsules twice a day Between 10 and 13.9kg: 4 capsules twice a day Between 14 and 19.9kg: 5 capsules twice a day Between 20 and 24.9kg: 6 capsules twice a day

DRUG

LPV/r Pellets (40/10mgs) plus ABC/3TC (60/30mgs)

Lopinavir/Ritonavir (40/10mg pellets) plus dual Abacavir/Lamivudine (60/30mg dispersible tablets) Dosage according to patient's weight: LPV/r Pellets: Between 3 and 5.9kg: 2 capsules twice a day Between 6 and 9.9kg: 3 capsules twice a day Between 10 and 13.9kg: 4 capsules twice a day Between 14 and 19.9kg: 5 capsules twice a day Between 20 and 24.9kg: 6 capsules twice a day ABC/3TC: Between 3 and 5.9kg: 1 tablet twice a day Between 6 and 9.9kg: 1.5 tablets twice a day Between 10 and 13.9kg: 2 tablets twice a day Between 14 and 19.9kg: 2.5 tablets twice a day Between 20 and 24.9kg: 3 tablets twice a day

Sponsors & Collaborators

• UNITAID

  collaborator OTHER

• AMS-PHPT Research Platform (Program for HIV Prevention and Treatment)

  collaborator UNKNOWN

• Joint Clinical Research Centre- Kampala

  collaborator UNKNOWN

• Baylor College of Medicine Childrens Foundation, Uganda

  collaborator UNKNOWN

• Epcentre Centre Mbarara Research Centre

  collaborator UNKNOWN

• Institute of Tropical Medicine, Belgium

  collaborator OTHER

• Drugs for Neglected Diseases

  lead OTHER

Principal Investigators

• Isabelle Andrieux-Meyer, MD · Drugs for Neglected Diseases initiative

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

4 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-06-04

Primary Completion

2019-11-30

Completion

2019-12-31

Countries

• Uganda

Study Locations