HIV/AIDS
Conditions
Interventions
Continue on DTG based Therapy
Switch to PI based Therapy
Sponsors
University of Nairobi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Enrolled in the Ndovu cohort study Able and willing to understand and comply with the protocol requirements, instructions and restrictions Able and willing to provide informed consent for the nested clinical trial (assent as appropriate and legal guardian consent if < 18 years) Age = 3 years Most recent HIV-1 RNA = 200 copies/mL At least one major DTG-associated DRM (substitution at codon 66K, 92Q, 118R, 138K/A/T, 140S/A/C, 148H/R/K, 155H or 263K)
Exclusion criteria
Exclusion criteria: Pregnant or breastfeeding Using any concomitant therapy disallowed as per the reference safety information and product labeling for the study drugs WHO stage 3 or 4 opportunistic infection which would prevent randomisation to either arm (e.g. due to drug interactions or significant liver or renal injury) within 4 weeks prior to RCT screening Investigator opinion that the potential participant should discontinue DTG immediately for clinical reasons Investigator opinion that the potential participant should not switch to DRV/r for clinical reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The comparative efficacy of switching to a DRV/r-based regimen after confirmed virologic failure and of remaining on DTG-based ART in achieving viral suppression of <200 copies/mL at 6 months from randomization among participants with =1 major DTG-associated DRM | — |
Secondary
| Measure | Time frame |
|---|---|
| Viral suppression to HIV-RNA of <200 copies/mL at 12 months from randomization;Evaluate if switching to DRV/r-based ART after virologic failure is superior to remaining on DTG-based ART in achieving viral suppression to <200 copies/mL at 6 months from randomization;Evaluate the difference in viral suppression using HIV-RNA cut-off of <50 copies/mL at 6 and 12 months from randomization;Evaluate the difference in viral suppression using HIV-RNA cut-off of <1,000 copies/mL at 6 and 12 months from randomization;Viral load suppression rate by age strata: 3-9, 10-19, =20, 20-24, 25-34, 35-44, and =45 years old;Viral load suppression based on participant's sex;Incidence and severity of adverse events and laboratory abnormalities;Adherence levels, based on DBS TFV-DP levels, associated with suppression and selection of treatment-emergent DRMs;Incidence of treatment-emergent DRMs over 12 months of follow-up;Describe the patterns of accumulated DRMs over 12 months of follow-up;Evaluate DRM patterns that are associated with sustained non-suppression;Investigate the predictors of selection of DTG-associated DRMs (age, other non-INSTI DRMs, VL at switch to DTG, time with viremia, etc.);Viral suppression based on pre-enrolment NRTI;Viral suppression based on TDF vs TAF as the study NRTI;The impact of regimen on change in CD4 count;Patient satisfaction as measured using the HIV Treatment Satisfaction Questionnaire - Status version (HIVTSQs) which scores 10 variables on a 7-point likert score ranging from 0 to 6 with a higher score representing a better outcome;Change in patient satisfaction as measured using the HIV Treatment Satisfaction Questionnaire - Change version (HIVTSQc) which scores 10 variables on a 7-point likert score ranging from -3 to +3 with a higher score representing a better outcome;Experiences and acceptability of remaining on DTG-containing ART or switching to DRV-containing ART for management of treatment failure to DTG-based ART regimens from perspectives of | — |
Countries
Kenya, Lesotho, Mozambique, Tanzania
Contacts
Public ContactJoseph Nkuranga
Study Coordinator
Outcome results
None listed