A Pharmacokinetics Study Comparing Lopinavir Plasma Exposure When Given as Lopinavir/Ritonavir (1:1) in the Presence of Rifampicin and Lopinavir/Ritonavir (4:1) Without Rifampicin in HIV and TB Co-infected Children in South Africa.

NCT02348177 Phase 4 COMPLETED

The purpose of this study is to determine the lopinavir levels in blood of HIV and TB infected children (3-15kg) when given lopinavir/ritonavir in a 1:1 ratio with rifampicin containing TB regimen and its safety.

Details

Lead sponsor	Drugs for Neglected Diseases
Phase	Phase 4
Status	COMPLETED
Enrolment	96
Start date	2013-01
Completion	2016-12

Conditions

• Acquired Immunodeficiency Syndrome
• Tuberculosis

Interventions

• lopinavir with ritonavir in 1:1 ratio
• Lopinavir/ritonavir 4:1

Primary outcomes

• Modelled C0/morning trough — Predose
  Proportions of children treated with modelled lopinavir morning C0/morning trough \<1mg/L at each of the intensive PK evaluations.

Countries

South Africa