- 1. Visit prefix nomenclature: Screening ‘S’; During ATI ‘A’; After Rebound ‘B’ After Second Rebound ‘C’
- 1. Screening and Enrolment visit may be combined into one visit where possible
- 2. 4-weekly visits repeated until viral rebound occurs
- 3. UNS: patients may request an additional ‘unscheduled’ visit to have HIV VL measured any time while still unsuppressed
- 4. bNAb sensitivity visit at screening not required if done as part of the HEATHER study
- 5. Arm B/Placebo participants (if they agree) will move to Stage 2 after viral rebound to continue with the study visits, B1 visit procedure will be conducted as per Stage 2 schedule, otherwise participants will follow Stage 1 visit schedule until the end of the study
- 6. #SARS-Cov-2 PCR will be conducted up to 72 h prior to randomisation/dosing visit and for the rest of the visits PCR will only be performed if participants exhibit COVID-19 (SARS-Cov-2) symptoms, however SARS-CoV-2 PCR testing can be offered to any asymptomatic participant attending at any study visit in accordance with local NHS guidelines, and participant or clinical team choice.
- 7. ATI Start visit (A2) can be conducted as an onsite or telephone visit if participant prefers
- 8. Arm B: Research bloods can be taken at the viral rebound visit or the Stage 2 dosing visit – not both visits.
- 9. SARS-Cov-2 antibodies blood test at screening is an optional test and is not used to determine if the patient is eligible for the study