Ranked Log10 HIV-1 RNA Viral Load (log10 Copies/mL) Averaged at 72 and 76 Weeks for the IT Arm and DT Arm At Weeks 72 and 76 [clinicaltrials_resource:8f2bfc3d49542642d6d9230581b23288]
The primary endpoint is (i) the average of log10 viral loads (VL) at wks 72 and 76 for participants who continued to wk 72 off ARV for the DT arm, (ii) average wk 72 and 76 VL for those who continued to wk 36 off ARV for the IT arm and (iii) an assigned VL rank for the "failures" who needed ARVs or met criteria for entry into Step 2 prior to these study visits. The assigned rank for the failures was either the last observed rank carried forward or the worst rank relative to the other possible outcomes. This approach was designed to, if anything, bias against finding a treatment effect. To illustrate, consider five participants who enter the study (A, B, C, D, and E), 4 of whom (A, B, C, D) make it to 72 wks off therapy with RNA levels that increase from A to D. Participant E enters Step 2 at wk 12, at which time his RNA is in the 50th percentile. This rank would be carried forward, so the rank order of the log10 HIV-1 RNA endpoints would be A B E C D.
clinicaltrials_vocabulary:primary outcome [clinicaltrials_vocabulary:clinicaltrials_vocabulary:primary-outcome]
Ranked Log10 HIV-1 RNA Viral Load (log10 Copies/mL) Averaged at 72 and 76 Weeks for the IT Arm and DT Arm At Weeks 72 and 76 [clinicaltrials_resource:8f2bfc3d49542642d6d9230581b23288]
The primary endpoint is (i) the average of log10 viral loads (VL) at wks 72 and 76 for participants who continued to wk 72 off ARV for the DT arm, (ii) average wk 72 and 76 VL for those who continued to wk 36 off ARV for the IT arm and (iii) an assigned VL rank for the "failures" who needed ARVs or met criteria for entry into Step 2 prior to these study visits. The assigned rank for the failures was either the last observed rank carried forward or the worst rank relative to the other possible outcomes. This approach was designed to, if anything, bias against finding a treatment effect. To illustrate, consider five participants who enter the study (A, B, C, D, and E), 4 of whom (A, B, C, D) make it to 72 wks off therapy with RNA levels that increase from A to D. Participant E enters Step 2 at wk 12, at which time his RNA is in the 50th percentile. This rank would be carried forward, so the rank order of the log10 HIV-1 RNA endpoints would be A B E C D.
Bio2RDF identifier
8f2bfc3d49542642d6d9230581b23288
Bio2RDF namespace
clinicaltrials_resource
Bio2RDF uri
http://bio2rdf.org/clinicaltrials_resource:8f2bfc3d49542642d6d9230581b23288
measure [clinicaltrials_vocabulary:measure]
Ranked Log10 HIV-1 RNA Viral L ...... eeks for the IT Arm and DT Arm
time frame [clinicaltrials_vocabulary:time-frame]
At Weeks 72 and 76
description
The primary endpoint is (i) th ...... endpoints would be A B E C D.
identifier
clinicaltrials_resource:8f2bfc3d49542642d6d9230581b23288
title
Ranked Log10 HIV-1 RNA Viral L ...... and DT Arm At Weeks 72 and 76
@en
type
label
Ranked Log10 HIV-1 RNA Viral L ...... bfc3d49542642d6d9230581b23288]
@en