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IMPAACT P1106: Pharmacokinetic Characteristics of Antiretrovirals and Tuberculosis Medicines in Low Birth Weight Infants

NCT02383849 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 124

Last updated 2021-08-06

No results posted yet for this study

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

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • International Maternal Pediatric Adolescent AIDS Clinical Trials Group

    lead NETWORK

Principal Investigators

  • Mark Cotton, MD, MBChB, FCPaed, MMED · University of Stellenbosch

  • Mark H Mirochnick, MD · Boston Medical Center

Eligibility

Min Age
7 Days
Max Age
84 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-04
Primary Completion
2020-02-14
Completion
2020-02-14

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02383849 on ClinicalTrials.gov