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Table 1 Secondary and exploratory endpoints

From: Genotype-Informed Versus Empiric Management Of VirEmia (GIVE MOVE): study protocol of an open-label randomised clinical trial in children and adolescents living with HIV in Lesotho and Tanzania

Endpoint Definition Timeframe
Secondary endpoints
Death due to any cause Proportion of participants confirmed dead during the follow-period among all participants enrolled Within 36 weeks after enrolment
HIV- or ART-related hospitalisation of ≥24 h duration Proportion of participants with HIV- or ART-related hospital admission(s) of ≥24 h duration (possibly, probably or definitely related to HIV or ART, judged by the endpoint committee blinded to the study arm) during the follow-up period among all participants enrolled Within 36 weeks after enrolment
New clinical WHO stage 4 event(s) Proportion of participants with new clinical WHO stage 4 event(s) (excluding lymph node tuberculosis, stunting, oral or genital herpes simplex infection and oesophageal candidiasis, judged by the endpoint committee blinded to the study arm) among all participants enrolled Within 36 weeks after enrolment
Without documentation of a suppressed VL Proportion of participants without documentation of a VL <50 c/mL at 9 months among all participants enrolled 32—44 weeks after enrolment
Loss to follow-up Proportion of participants with no documented clinic visit at 9 months among all participants enrolled 32—44 weeks after enrolment
Observed virologic failure Proportion of participants with a VL ≥50 c/mL among all participants with a VL result at 9 months 32—44 weeks after enrolment
Composite endpoint at 6 months after the decision on onward treatment Proportion of participants among all participants enrolled experiencing any one or more of the events i) death due to any cause within 24 weeks of the decision on onward treatment, ii) HIV- or ART-related hospital admission of ≥24 h duration (possibly, probably or definitely related to HIV or ART, judged by the endpoint committee blinded to the study arm) within 24 weeks of the decision on onward treatment, iii) new clinical WHO stage IV event (excluding lymph node tuberculosis, stunting, oral or genital herpes simplex infection and oesophageal candidiasis; judged by the endpoint committee blinded to the study arm) within 24 weeks of the decision on onward treatment, and iv) no documentation of a suppressed VL (<50 c/mL) at 6 months (20–28 weeks) after the choice of onward treatment. The time point of the decision on onward treatment is defined as the first visit in which the follow-up VL result (control arm) or the GRT result (intervention arm) is available. i-iii): within 24 weeks after the decision on onward therapy;
iv): 20—28 weeks after the decision on onward therapy
Exploratory endpoints
Time to documented viral suppression Time to achieving a VL <50 c/mL; considering VL testing done with samples from the 3-, 6- and 9-month study visits in both arms Assessed at 3- (10—14 weeks after enrolment), 6- (20—28 weeks after enrolment), and 9-month study visit (32—44 weeks after enrolment)
Drug regimen switches in the absence of major resistance-associated mutations and/or non-switches in the presence of major resistance-associated mutations Proportion of participants with ART regimen switches in the absence of major resistance-associated mutations and/or non-switches in the presence of major resistance-associated mutations among all participants enrolled (as identified by Sanger sequencing, according to the Stanford HIV drug resistance database). Assessed at enrolment and at 9-month study visit (32—44 weeks after enrolment)
Proportion with new resistance-associated mutations emerged within the study period Proportion of participants with new resistance-associated mutations emerged within the study period among all participants enrolled Change from enrolment to 9-month study visit (32—44 weeks after enrolment)
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