Oligonucleotide Ligation Assay (OLA) Resistance Study

NCT01898754 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 991

Last updated 2025-03-12

Study results available
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Summary

The investigators propose to gauge improvements in the rate of durable suppression of viral replication by ART when OLA is used to guide clinical decisions at the PEPFAR Coptic Hope Center in Kenya, and to determine the cost-effectiveness of implementing this strategy at Coptic Hope Center.

Conditions

  • HIV Positive

Interventions

OTHER

Pre-ART Oligonucleotide Assay (OLA)

Block randomization (1:1) to pre-ART OLA testing or OLA testing after 12mo on ART

Sponsors & Collaborators

  • Seattle Children's Hospital

    collaborator OTHER
  • University of Nairobi

    collaborator OTHER
  • University of Washington

    lead OTHER

Principal Investigators

  • Lisa Frenkel, MD · University of Washington, Seattle Children's Research Institute

  • Michael H Chung, MD, MPH · Department of Global Health, University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2016-12-31
Completion
2017-02-28

Countries

  • Kenya

Study Locations

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Entities

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 NCT01898754 on ClinicalTrials.gov