Impacts of HIV Treatment Regimens on Archived Drug Resistance
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChinese University of Hong Kong
About this trial
The study aims to determine the prevalence of drug resistance mutation (DRM) in virally suppressed HIV infection, and the impacts of regimen change and the presence of low level viremia. Adults living with HIV infection on antiretroviral therapy (ART) with full viral suppression would be recruited. Cases are patients planning for regimen switch, while controls are those with and without low level viraemia (LLV) not planned for switch. Blood samples would be collected before and after switch. Sequencing would be performed to identify DRM present in HIV-1 proviral DNA.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients living with HIV who are (a) aged 18 or above, (b) on antiretroviral therapy, (c) has viral load <20 copies/mL at 2 time points for ≥6 months, (d) planning regimen switch.
Patients for inclusion in the control group meet the same criteria (a) but they are not planned for switch. Controls include patients with low level viremia (LLV) as defined as ≥2 consecutive viral load level between 21 and 200 copies/mL in the preceding 2 years.
Disqualifiers
Patients living with HIV who (a) are pregnant, (b) have virologic failure, (c) are suffering from concurrent opportunistic infections, (d) are prisoners , (e) are unable to give consent, and (f) have mental illnesses.
Trial population
Patients living with HIV and who are attendees of HIV specialist clinics in the public service in Hong Kong
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
420 Participants
are grouped into 2 trial groupsGroup A: Patients on ART planning for regimen switch
Group B: Patients on ART not for regimen switch
Trial outcomes
Primary outcomes
1
Proportional difference of drug resistance mutation at short term after regimen switch
Percentage difference between the prevalence of drug resistance mutation (DRM) detected by proviral DNA testing at baseline and short term (3-6 months) after regimen switch
Time frame
from enrolment to 3-6 months2
Proportional difference of drug resistance mutation at long term after regimen switch
Percentage difference between the prevalence of drug resistance mutation (DRM) detected by proviral DNA testing at baseline and long term (2-3 years) after regimen switch
Time frame
From enrolment to 2-3 years after regimen switchSecondary outcomes
1
Prevalence of drug resistance mutation
Percentage of patients on antiretroviral therapy with drug resistance mutation (DRM) detected by proviral DNA testing at baseline
Time frame
at enrolment2
Proportional Difference of drug resistance mutation prevalence between patients with and without by low level viremia
Percentage difference in the prevalence of drug resistance mutation (DRM) detected by proviral DNA testing between the presence and absence of low level viremia at baseline
Time frame
at enrolmentOther outcomes
1
Prevalence of virologic failure
Prevalence of virologic failure in patients on antiretroviral therapy at 2-3 years after enrolment
Time frame
From enrolment to 2-3 yearsSponsors and contacts
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Source ClinicalTrials.gov