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Virologic Treatment Failure and Drug Resistance in HIV-infected Kenyan Children (RESPECT)

NCT03120065 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 499

Last updated 2020-07-22

No results posted yet for this study

Summary

The primary objective of this study is to use a well-characterized pediatric AMPATH cohort, with detailed medication-taking, drug level, and clinical data, to longitudinally evaluate treatment failure and drug resistance to improve long-term care for HIV-infected children in Kenya and other RLS. Examining treatment failure and drug resistance emergence in children on ART and what factors impact these negative outcomes, will provide needed data to critically evaluate the efficacy of current ART, weight-based pediatric drug dosing guidelines, and recommendations for subsequent therapies. The objective is to specifically characterize how non-adherence leads to a lack of viral suppression and to drug resistance evolution, and how this characterization can inform interventions to improve adherence and increase treatment success.

Conditions

  • Viral Resistance
  • Treatment Failure

Interventions

OTHER

Electronic Dose Monitoring (MEMS)

The MEMS cap is an electronic bottle cap that records the time and date of a bottle being opened. The research personnel will extract the timing of the MEMS bottle opening events for adherence analysis.

Sponsors & Collaborators

  • Moi University

    collaborator OTHER

  • Brown University

    collaborator OTHER

  • Rachel Vreeman, MD, MS

    lead OTHER

Principal Investigators

  • Rachel C Vreeman, MD, MS · Indiana University School of Medicine

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-24
Primary Completion
2018-08-30
Completion
2018-08-30

Countries

  • Kenya

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 NCT03120065 on ClinicalTrials.gov