You are viewing the site in preview mode

Skip to main content

Advertisement

Table 2 Secondary, exploratory and subgroup endpoints of the SESOTHO trial

From: SESOTHO trial (“Switch Either near Suppression Or THOusand”) – switch to second-line versus WHO-guided standard of care for unsuppressed patients on first-line ART with viremia below 1000 copies/mL: protocol of a multicenter, parallel-group, open-label, randomized clinical trial in Lesotho, Southern Africa

  Definition Time point following randomization Remarks
Secondary endpoints
 VL level Proportion of participants with different levels (VL < 100, < 200, < 400, < 1000 copies/mL) 9 months  
 VL at 6 months Proportion of participants with viral resuppression (< 50 copies/mL) 6 months  
 Sustained virologic failure Proportion of participants with unsuppressed VL > 50 copies/mL at 6 and 9 months 6 and 9 months  
 Adherence Proportion of participants with good adherence 3, 6, and 9 months Definition of “good adherence”: self-reported no dose missed of a once-daily-regimen, respectively less than two doses of a twice-daily-regimen, during the last month
 Clinical outcomes Change in values (versus values at baseline) of body-weight (kg), CD4-cell count (cells/μL), haemoglobin (g/dL), lipids (total cholesterol, LDL, HDL, triglycerides; mmol/L); proportion of patients with newly-recorded clinical WHO-stage 3 or 4 events; proportion of patients died (all-causes) 9 months  
 (Serious) Adverse Events Proportion of patients with Adverse Events (AE) or Serious Adverse Events (SAE) 9 months AE and SAE are graded according to Common Terminology Criteria for Adverse Events (v4.0, published May 28, 2009)
 Long-term follow-up Proportion of patients that are alive, retained in care and virologically suppressed 24 months Definition of “virologically suppressed”: < 50 copies/mL
Potential effect modifiers
 Primary endpoint by demographic groups Viral resuppression by adults vs children vs pregnant women 9 months Definition of “viral resuppression”: < 50 copies/mL
 Primary endpoint by baseline VL groups Viral resuppression by baseline VL 100–599 vs 600–999 copies/mL 9 months Definition of “viral resuppression”: < 50 copies/mL
Exploratory endpoints
 Cost-effectiveness Staff costs (clinical and laboratory); costs of ARVs; costs of drugs for prevention of opportunistic infections and other concomitant medications; laboratory costs (CD4 cell count, VL, blood chemistry, blood count and other diagnostic procedures); estimation of health impact/benefits outcomes (e.g. DALY) Between baseline and 9 months and 24 months (long-term follow-up)  
 Drug resistance mutations Prevalence of major drug resistance mutations a) on all baseline VLs and b) on all VLs that remain unsuppressed (> 50 copies/mL) at 9 months for all samples for which an RT-PCR amplification is successful At baseline and at 9 months Definition of “major drug resistance mutations”: Stanford University HIV Resistance Database (http://hivdb.stanford.edu)
Subgroup endpoint
 Log-drop Viral resuppression among individuals with a > 0.5 drop in log10 VL between the first screening VL and the second screening VL (i.e. VL at enrolment) 9 months Definition of “viral resuppression”: < 50 copies/mL