Status:
COMPLETED
The Intensified Treatment Monitoring Strategy to Prevent Accumulation of Drug Resistance (ITREMA) Trial
Lead Sponsor:
UMC Utrecht
Collaborating Sponsors:
ZonMw: The Netherlands Organisation for Health Research and Development
Ndlovu Care Group
Conditions:
HIV/AIDS
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Detailed Description
This study will enroll adult HIV-1 infected patients who are about to initiate or have already initiated first-line ART. Patient enrollment and randomization will be performed at two different time po...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
June 29 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2022
Estimated Enrollment :
501 Patients enrolled
Trial Details
Trial ID
NCT03357588
Start Date
June 29 2015
End Date
May 1 2022
Last Update
May 11 2022
Active Locations (1)
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1
Ndlovu Medical Centre
Elandsdoorn, Limpopo, South Africa, 0485