HIV infection MedDRA version: 9.1 Level: LLT Classification code 10008922 Term: Chronic infection with HIV
Conditions
Interventions
Trade Name: Kaletra 200mg/50mg film-coated tablets
Pharmaceutical Form: Tablet
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: HIV positive Pregnant Taking or about to start taking Kaletra as part of standard medical care Able to give informed consent Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Decompensated Liver disease Likely to deliver within two weeks of study entry Use of concomitant therapy known to interfer with lopinavir pharmacokinetics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the plasma concentrations of lopinavir during pregnancy (when adminstered as a film coated tablet).;Secondary Objective: To determine the effect of physiological changes during pregnancy on protein binding of lopinavir To determine the antiviral effect of antiretroviral therapy that includes lopinavir as prescribed during pregnancy;Primary end point(s): Plasma concentrations of lopinavir | — |
Countries
United Kingdom
Outcome results
None listed