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IMPAACT P1092: Steady State PK in Malnourished HIV Infected Children

NCT01818258 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2021-08-12

Study results available
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Summary

Children living with HIV from sub-Saharan Africa often present with severe malnutrition. In severe malnutrition, metabolic and/or gut structural derangement may lead to inadequate antiretroviral (ARV) absorption and/or erratic drug levels. The greater surface area to weight ratio in severely malnourished children could also place them at higher risk of under dosing compared to children with mild to moderate malnutrition. However, limited data are available on the pharmacokinetics of ARVs in severely malnourished children. This study addressed this critical gap in knowledge by evaluating the PK of zidovudine (ZDV), lamivudine (3TC), and lopinavir/ritonavir (LPV/r) in severely malnourished children living with HIV, compared to children with normal nutrition to mild malnutrition living with HIV.

Conditions

  • HIV Positive
  • Malnourished

Interventions

DRUG

ZDV+3TC+LPV/r

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

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • International Maternal Pediatric Adolescent AIDS Clinical Trials Group

    lead NETWORK

Principal Investigators

  • Maxensia O Owor, MBChB, MMED, MPH · International Maternal Pediatric Adolescent AIDS Clinical Trials Group

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
36 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-26
Primary Completion
2017-04-11
Completion
2017-09-29

Countries

  • Malawi
  • Tanzania
  • Uganda
  • Zimbabwe

Study Locations

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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 NCT01818258 on ClinicalTrials.gov