MedTrace Logo

Resistance Testing to Improve Management of Virologic Failure in Sub-Saharan Africa

NCT02787499 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 840

Last updated 2023-03-21

Study results available
· View outcomes & findings →

Summary

The study design is an open-label, randomized controlled trial. The study will be conducted at study sites in Uganda and South Africa. The study population will include HIV-infected patients on first-line antiretroviral therapy with a recent viral load \>1,000 copies/milliliter (or dried blood spot viral load \>1,000 copies/milliliter). Eligible participants will be randomized to the WHO-based standard of care for management of virologic failure or immediate resistance testing to guide ART regimen decisions. The primary outcome of interest will be viral suppression (\<200 copies/mL) at 9 months after study enrollment, and will be assessed using an intention to treat analysis, where missing or absent results will be considered failures. Secondary outcomes of interest will be viral suppression below the limit of assay detection, viral suppression on continuation of first-line (non-nucleoside reverse transcriptase inhibitor \[NNRTI\]-based) therapy, drug resistance at study conclusion, and mortality, among others. The overarching goal of this study is to determine whether addition of routine resistance testing, to guide management of virologic failure and sustain the successful completion of the HIV continuum of care, improves clinical outcomes and reduces costs for patients with virologic failure on first-line therapy in sub-Saharan Africa.

Conditions

Interventions

PROCEDURE

HIV-1 RNA Resistance Testing

Perform drug resistance on enrollment to guide management of virologic failure

Sponsors & Collaborators

  • Mbarara University of Science and Technology

    collaborator OTHER

  • University of KwaZulu

    collaborator OTHER

  • Emory University

    collaborator OTHER

  • University of Rochester

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Mwebesa Bwana, MBChB MPH · Mbarara University of Science and Technology

  • Yunus Moosa, MBChB PhD · University of KwaZulu

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-08
Primary Completion
2020-09-08
Completion
2020-09-08

Countries

  • South Africa
  • Uganda

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 NCT02787499 on ClinicalTrials.gov