Trials / Completed
CompletedNCT02383849
IMPAACT P1106: Pharmacokinetic Characteristics of Antiretrovirals and Tuberculosis Medicines in Low Birth Weight Infants
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 124 (actual)
- Sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group · Network
- Sex
- All
- Age
- 7 Days – 84 Days
- Healthy volunteers
- Not accepted
Summary
P1106 is Phase IV prospective pharmacokinetic (PK) study of low birth weight infants who are receiving or will be receiving as part of clinical care nevirapine (NVP) prophylaxis, tuberculosis (TB) prophylaxis or treatment and/or combination antiretroviral (ARV) treatment containing lopinavir/ritonavir (LPV/r). The study is designed to describe the pharmacokinetics and safety of NVP, INH, RIF, and LPV/r in these infants receiving the drug(s) as part of clinical care.
Conditions
Timeline
- Start date
- 2015-08-04
- Primary completion
- 2020-02-14
- Completion
- 2020-02-14
- First posted
- 2015-03-09
- Last updated
- 2021-08-06
Locations
2 sites across 1 country: South Africa
Source: ClinicalTrials.gov record NCT02383849. Inclusion in this directory is not an endorsement.