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

NCT02346487 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1003

Last updated 2019-05-20

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • UNITAID

    collaborator OTHER

  • French Development Agency

    collaborator OTHER_GOV

  • Drugs for Neglected Diseases

    lead OTHER

Principal Investigators

  • Dalton Wamalwa, MD · University of Nairobi, P.O Box 19676 00202 Nairobi

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2019-05-14
Completion
2019-05-14

Countries

  • Kenya
  • Tanzania
  • 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 NCT02346487 on ClinicalTrials.gov