Pharmacokinetics of lopinavir/ritonavir superboosting in infants and young children co-infected with HIV and TB
- Conditions
- HIV/AIDSTuberculosis
- Registration Number
- PACTR201302000426554
- Lead Sponsor
- Drugs for Neglected Diseases Initiative
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 90
Documentation of a confirmed diagnosis of HIV-1 infection following SA clinical guidelines
Weight >3kg and > 42 weeks gestational age
On LPV/r-based therapy or about to start a LPV/r-based antiretroviral combination therapy with 2 NRTIs [ABC+3TC or AZT+3TC or d4T+3TC]
Clinical diagnosis of TB requiring rifampicin-based therapy
Parent or legal guardian able and willing to provide written informed consent and able to attend study visits.
For neonates, less than 42 weeks gestation and 14 days old
Concomitant/chronic treatment with potent enzyme-inducing/inhibiting drugs other than those in the study treatments . See Appendix E (minor inducers/inhibitors and drugs used as part of management of the condition are allowed eg. Steroids)
Anticipation at the start that anti-TB treatment duration will be longer than 9 months
Any other condition/finding that, in the investigator¿s opinion, would compromise the child¿s participation in this study eg. alanine transferase (ALT) more than 10 times upper limit of normal (ULN), or chronic renal, hepatic or gastrointestinal disease such as malabsorption.
Children with known malignancies and contraindications to taking LPV/r
Treatment with experimental drugs for any indication within 30 days prior to study entry; participation in another study may be approved by the study team.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To demonstrate that the proportion of subjects achieving LPV C0/morning trough above 1mg/L during superboosting of LPV with RTV (in a 1:1 ratio) while on RIF-based anti-TB treatment, is not inferior the proportion of subjects achieving LPV C0/morning trough above 1 mg/L during ART with LPV/r (in a 4:1 ratio) in the absence of anti-TB treatment
- Secondary Outcome Measures
Name Time Method