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

NCT03357588 | Completed

• 1 other identifier: 69/2015
• Study Type: interventional
• Target: 501
• Locations: 1 country
• Sites: 1

Brief 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

HIV/AIDS

Outcome Measures

Primary Outcomes (4)

• Drug resistance

  Prevalence of drug resistance in patients with therapy failure in each arm

  week 48

• Drug resistance

  Prevalence of drug resistance in patients with therapy failure in each arm

  week 96

• Unnecessary treatment switches

  Number of virological failure cases without drug resistance in the intervention arm (averted unnecessary treatment switches) versus in the control arm (unnecessary treatment switches)

  week 48

• Unnecessary treatment switches

  Number of virological failure cases without drug resistance in the intervention arm (averted unnecessary treatment switches) versus in the control arm (unnecessary treatment switches)

  week 96

Secondary Outcomes (3)

• Time on failing regimen

  week 96

• Loss of second line therapeutic options over time

  week 96

• Influence of genotypic resistance testing

  week 96

Study Arms (2)

Control

ACTIVE COMPARATOR

Standard of Care monitoring

Other: Standard of care monitoring

Intervention

EXPERIMENTAL

Intensified monitoring

Other: Intensified monitoring

Interventions

Intensified monitoring OTHER

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.

Intervention

Standard of care monitoring OTHER

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.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV-1 infected male or female patients
• For ART Naïve patients: Eligible for and intending to initiate ART at the clinical site
• For patients on ART: On ART ≥1 year. Last VL \<6 months ago and \<1000 copies/mL
• ≥18 years of age
• Able to understand and willing to give informed consent

You may not qualify if:

• Any serious unstable medical condition at study baseline
• Any criteria that in the opinion of the investigator indicate that the patient is unable to participate in the full study.

Sponsors & Collaborators

• UMC Utrecht: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator
• Ndlovu Care Group: collaborator
• Wits Reproductive Health and HIV Institute: collaborator

Study Sites (1)

Ndlovu Medical Centre

Elandsdoorn, Limpopo, 0485, South Africa

Location

Related Publications (2)

• Gumede SB, Wensing AMJ, Lalla-Edward ST, de Wit JBF, Francois Venter WD, Tempelman HA, Hermans LE. Predictors of Treatment Adherence and Virological Failure Among People Living with HIV Receiving Antiretroviral Therapy in a South African Rural Community: A Sub-study of the ITREMA Randomised Clinical Trial. AIDS Behav. 2023 Dec;27(12):3863-3885. doi: 10.1007/s10461-023-04103-2. Epub 2023 Jun 29.

  PMID: 37382825 DERIVED

• Hermans LE, Nijhuis M, Tempelman HA, Houts T, Schuurman R, Burger DM, Wensing AMJ, ter Heine R. Point-of-Care Detection of Nonadherence to Antiretroviral Treatment for HIV-1 in Resource-Limited Settings Using Drug Level Testing for Efavirenz, Lopinavir, and Dolutegravir: A Validation and Pharmacokinetic Simulation Study. J Acquir Immune Defic Syndr. 2021 Aug 1;87(4):1072-1078. doi: 10.1097/QAI.0000000000002681.

  PMID: 34153013 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Annemarie MJ Wensing, MD, PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Virologist, Head of Medical Microbiology Residency Program

Study Record Dates

• First Submitted: September 28, 2017
• First Posted: November 30, 2017
• Study Start: June 29, 2015
• Primary Completion: March 1, 2019
• Study Completion: May 1, 2022
• Last Updated: May 11, 2022

Record last verified: 2022-05

Locations

ZA (1)