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

NCT02346487 Phase 3 COMPLETED

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.

Details

Lead sponsor	Drugs for Neglected Diseases
Phase	Phase 3
Status	COMPLETED
Enrolment	1003
Start date	2015-09
Completion	2019-05-14

Conditions

• HIV

Interventions

• LPV/RTV pellets and AZT/3TC or ABC/3TC

Primary outcomes

• Treatment effectiveness at 48 weeks based on a composite endpoint of: i) virologic response <1000 copies/ml ii) being alive and iii) on study drug — 48 weeks
  • Treatment effectiveness at 48 weeks based on a composite endpoint of: i) virologic response \<1000 copies/ml ii) being alive and iii) on study drug

Countries

Kenya, Tanzania, Uganda