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"Switch Either Near Suppression Or THOusand"

NCT03088241 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2022-03-22

No results posted yet for this study

Summary

This trial addresses the question of the viral load (VL) threshold for switching from first-line to second-line antiretroviral therapy (ART). The WHO currently sets the threshold at 1000 copies/mL. However, the optimal threshold for defining virological failure and the need to switch ART regimen has not been determined. In fact, people with VL levels of less than 1000 copies/mL, however, not fully suppressed, are at increased risk for drug resistance mutations (DRM) and subsequent virological failure. In resource-limited settings where VL monitoring is not as frequent as in high-income countries, this could have serious implications and patients may continue on a failing regimen for a long period. Our research consortium will conduct a multicenter, parallel-group, open-label, randomized clinical trial in a resource-limited setting to assess whether a threshold of 100 copies/mL compared to the WHO-defined threshold of 1000 copies/mL for switching to second-line ART among unsuppressed HIV-positive patients on first-line ART will lead to better outcomes.

Conditions

Interventions

OTHER

switch

switch to second-line ART

Sponsors & Collaborators

  • Swiss Tropical & Public Health Institute

    collaborator OTHER

  • SolidarMed, Lucerne, Switzerland

    collaborator UNKNOWN

  • SolidarMed

    collaborator OTHER

  • University of Basel

    collaborator OTHER

  • University Hospital, Basel, Switzerland

    collaborator OTHER

  • Butha-Buthe Hospital, Lesotho

    collaborator UNKNOWN

  • Ministry of Health, Lesotho

    collaborator OTHER_GOV

  • Niklaus Labhardt

    lead OTHER

Principal Investigators

  • Niklaus Labhardt, MD MIH · Swiss Tropical and Public Health Institute, Basel

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2020-05-23
Completion
2020-05-23

Countries

  • Lesotho

Study Locations

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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 NCT03088241 on ClinicalTrials.gov