HIV/AIDS
Conditions
Interventions
Switch to long acting injectible CAB and RPV.
Sponsors
Desmond Tutu Health Foundation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All cohorts: • Known HIV-positive; • Aged 12 - 24 years inclusive; • Clinically well (no current HIV-related illnesses); • Willing to switch to a long-acting injectable ART regimen for a 48-week period; • Be virally suppressed at time of switch; • Willing to be followed by the study team for 96 weeks after switch; • Able to understand and comply with protocol requirements and sign full informed assent / consent; • For women of child bearing potential, be willing to use effective contraception for the duration of the study (including the follow-up phase). This includes the use of oral or injectable hormonal contraceptives, a contraceptive implant or an intrauterine device (IUD). In addition, for cohort 1 (n=75): • Currently receiving standard of care first-line ART; • Suppressed viral load at the last 2 measurements (indicating >1 year of viral suppression). • No evidence of recent poor adherence (e.g. missed clinic visits or missed pharmacy collection). In addition, for cohort 2 (n=50): • Currently receiving standard of care first-line ART; • Most recent clinic viral load unsuppressed (but previous viral load suppressed) OR other evidence of poor adherence in past year (e.g. a missed pharmacy collection or missed clinic visits); • Willing to receive enhanced adherence support prior to switch. In addition, for cohort 3 (n=75) • ART naïve, by self-report. • About to commence standard of care first-line ART; from the Tutu Teen Truck mobile services.
Exclusion criteria
Exclusion criteria: • Adolescent or caregiver unwilling to participate in an ART switch study; • History of seizures or people at risk of seizures; • Abnormal liver function (>2.5 x ULN ALT or AST); • Evidence of Hepatitis B infection (positive Hep B surface antigen or anti-core AB); • People who are at high risk of suicide; • Women who are pregnant or breastfeeding; • Use of prohibited medication (e.g. rifampicin). • Any pre-existing physical or mental condition (including substance use disorder) which, in the opinion of the Investigator, may interfere with the participant’s ability to comply with the dosing schedule or which may compromise the safety of the participant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Acceptability of injectable method of ART delivery by adolescents (drawn from injection site reaction and adverse event data, as well as qualitative data from IDIs). 2.Feasibility of delivering injectable ART in a community setting (drawn from adherence to injection schedule by each cohort, and from key informant interviews). 3.Adherence to study visits and to injectable product over the study period | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Effectiveness of long-acting injection regimen in each cohort (drawn from rate of ongoing viral suppression at end of injection period) 2. Pharmacokinetics of LA CAB and RPV in adolescents (drawn from sparse PK data from injections at weeks 8, 24 and 48). 3. To assess viral resistance in participants experiencing virologic failure (Viral load = 50 copies/ml at any visit beyond week 0) | — |
Countries
South Africa
Contacts
Public ContactNyiko Mashele
Study coordinator
Outcome results
None listed