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The Intensified Treatment Monitoring Strategy to Prevent Accumulation of Drug Resistance (ITREMA) Trial

NCT03357588 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 501

Last updated 2022-05-11

No results posted yet for this study

Summary

The ITREMA trial is an open-label randomized controlled trial (RCT) in which HIV-1 infected patients initiating first-line ART and already on first-line ART will be enrolled. Enrollment will continue until 600 patients have been randomized. Patients initiating ART will be randomized after six months of ART and patients already on ART will be randomized at 6 months after the last viral load measurement. Patients in both arms will receive study visits every three months for a total follow-up duration of 18 months after randomization to either of two study arms. The control arm will receive standard of care HIV-1 treatment monitoring during first-line ART in accordance with South African National Department of Health (NDoH) guidelines. The intervention arm will receive intensified treatment monitoring during first-line ART according to the treatment monitoring strategy under investigation.

Conditions

Interventions

OTHER

Intensified monitoring

Intensified virological monitoring during first-line ART with viral load monitoring at month 6 of ART and 3-monthly thereafter, followed-up consecutively by point-of-care qualitative drug level testing and drug resistance testing in case of a viral load \>1000 copies/mL, during first-line antiretroviral treatment (ART) for HIV-1 infection as prescribed by South African national guidelines.

OTHER

Standard of care monitoring

Standard-of-care virological monitoring during first-line ART as described by WHO and South African National Department of Health ART guidelines, consisting of viral load monitoring at month 6 and 12 of ART and annually thereafter, followed-up by a repeat measurement within 3 months after a viral load \>1000 copies/mL, during first-line antiretroviral treatment (ART) for HIV-1 infection as prescribed by South African national guidelines.

Sponsors & Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • Ndlovu Care Group

    collaborator UNKNOWN

  • Wits Reproductive Health and HIV Institute

    collaborator OTHER

  • UMC Utrecht

    lead OTHER

Principal Investigators

  • Annemarie MJ Wensing, MD, PhD · UMC Utrecht

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-29
Primary Completion
2019-03-31
Completion
2022-05-31

Countries

  • South Africa

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 NCT03357588 on ClinicalTrials.gov