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

NCT03120065 | Completed

• 1 other identifier: 1601396087
• Study Type: interventional
• Target: 499
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

adherence

Outcome Measures

Primary Outcomes (1)

• Viral Resistance

  Blood samples will be analyzed for viral resistance testing, both for retrospective and prospective samples samples (TP1)

  18 months

Secondary Outcomes (9)

• Adherence MEMS

  3 months

• Adherence CAMP

  3 months

• Clinical Data: WHO stage

  6 years

• Clinical Data: Viral Load

  6 years

• Clinical Data: Weight

  6 years

Study Arms (1)

MEMS follow up

OTHER

Approximately 25% of the enrolled study population will have their adherence to medicines monitored by research personnel through the use of electronic dose monitoring caps (MEMS) for a period of 3 months. The participant's ART medication regimen will be dispensed in a bottle with a cap that monitors the time and date in which the cap is opened. Each month, the participant will bring the bottle with them on their clinic day for three months and the research personnel will extract the timing information from the cap.

Other: Electronic Dose Monitoring (MEMS)

Interventions

Electronic Dose Monitoring (MEMS) OTHER

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.

MEMS follow up

Eligibility Criteria

• Age: 4 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Previous enrollment in CAMP study
• Viable banked blood sample; HIV-infected documented by DNA-PCR (Amplicor, Roche, Basel, Switzerland) for children less than 18 months of age and by 2 parallel HIV rapid ELISA tests using Determine and Bioline for children older than 18 months of age.
• \< 19 years of age

You may not qualify if:

• Mental or physical incapacity of legal caregiver leading to inability to provide informed consent

Sponsors & Collaborators

• Rachel Vreeman, MD, MS: lead
• Moi University: collaborator
• Brown University: collaborator

Study Sites (1)

Moi Teaching and Referral Hospital - AMPATH Center

Eldoret, 30100, Kenya

Location

MeSH Terms

Interventions

Micro-Electrical-Mechanical Systems

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Rachel C Vreeman, MD, MS

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 6, 2017
• First Posted: April 19, 2017
• Study Start: April 24, 2017
• Primary Completion: August 30, 2018
• Study Completion: August 30, 2018
• Last Updated: July 22, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)