Efficacy of Lopinavir in Pregnancy: Pharmacokinetic and Virological Studies with Kaletra melt extruded tablet formulation - Lopinavir in Pregnancy
- Conditions
- HIV infectionMedDRA version: 9.1Level: LLTClassification code 10008922Term: Chronic infection with HIV
- Registration Number
- EUCTR2007-000438-38-GB
- Lead Sponsor
- Imperial College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
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
Decompensated Liver disease
Likely to deliver within two weeks of study entry
Use of concomitant therapy known to interfer with lopinavir pharmacokinetics
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method