NCT02346487

Prospective Study of Lopinavir Based ART for HIV Infected childreN Globally (LIVING Study)

Prospective Study of Lopinavir Based ART for HIV Infected childreN Globally

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,003 (actual)
• Sponsor: Drugs for Neglected Diseases · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The study will be carried out to provide supportive clinical data on the feasibility, efficacy, safety, and PK of LPV based therapies in routine treatment setting and will be based on the existing LPV/r pellets which already represent a clear advantage in comparison with the liquid formulation.

Detailed description

The primary objective is to evaluate the effectiveness of LPV/r pellets in addition to AZT/3TC (or ABC/3TC) paediatric fixed dose combination (FDCs) tablet under routine treatment conditions in HIV infected infants and young children who cannot swallow tablets. As secondary objectives: * Document the safety of LPV/r pellets and AZT/3TC or ABC/3TC * Assess the population pharmacokinetics of LPV/r and NRTIs when administered as LPV/r pellets plus AZT/3TC or ABC/3TC * Measure adherence to the new formulation * Evaluate children acceptability of the LPV/r pellets and associated dual NRTIs as well as ease of use by the care giver.

Conditions

• HIV

Interventions

Type	Name	Description
DRUG	LPV/RTV pellets and AZT/3TC or ABC/3TC	Drug: LPV/r pellets 40/10 mg: orally taken twice a day. 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: NRTIs (AZT/3TC 60/30mg tablet or ABC/3TC 60/30mg tablet). Dosage according to patient's weight: * 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

Timeline

• Start date: 2015-09-01
• Primary completion: 2019-05-14
• Completion: 2019-05-14
• First posted: 2015-01-27
• Last updated: 2019-05-20

Locations

11 sites across 3 countries: Kenya, Tanzania, Uganda