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Screening Period

(up to 75 days before Day 1)

Clinical and Other Assessments
  • Informed consent
  • Eligibility verification
  • Demography1
  • Prior ARV history
  • Medical history
  • CV risk assessment
  • Height, weight (W) and BMI
  • Vital signs
  • Physical exam (Full)
  • CDC HIV-1 Classification
  • HIV-associated conditions
  • Concomitant Medications
  • Adverse event (AE)/ SAE assessments
  • ECG: triplicate reading
Laboratory Assessments
  • Quantitative plasma HIV-1 RNA
  • T-cell Lymphocyte subset
  • Plasma back-up sample for storage3
  • Clinical Chemistry
  • Hematology
  • PT/PTT/INR
  • Fasting Lipids and glucose
  • Urinalysis
  • Pregnancy test for POCBP only (Serum)
  • HBsAg, anti-HBc, Anti-HBs, and reflex HBV DNA
  • HCV antibody and reflex HCV RNA
  • Rapid Plasma Reagin (RPR)
  • Whole blood (PBMC)6
Patient Reported Outcomes
  • Columbia Suicidality Severity Rating Scale (C-SSRS)
Study Treatment

Intervention Period

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Day 1 – Baseline

Below is the schedule of assessments (SOA) for this stage of the study protocol.

Clinical and Other Assessments
  • Eligibility verification
  • Height, weight (W) and BMI
  • Vital signs
  • Physical exam (Targeted)
  • CDC HIV-1 Classification
  • HIV-associated conditions
  • Concomitant Medications
  • Adverse event (AE)/ SAE assessments
  • ECG: triplicate reading
Laboratory Assessments
Patient Reported Outcomes
  • Columbia Suicidality Severity Rating Scale (C-SSRS)
  • Acceptability of treatment (ACCEPT)
  • HIVTSQ (status)
  • EQ-5D 3L
Study Treatment
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Week 1

Below is the schedule of assessments (SOA) for this stage of the study protocol.

Clinical and Other Assessments
  • Physical exam (Targeted)
  • HIV-associated conditions
  • Concomitant Medications
  • Adverse event (AE)/ SAE assessments
  • ECG: single reading
Laboratory Assessments
Patient Reported Outcomes
  • None
Study Treatment
  • None
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Week 2

Below is the schedule of assessments (SOA) for this stage of the study protocol.

Clinical and Other Assessments
  • Physical exam (Targeted)
  • HIV-associated conditions
  • Concomitant Medications
  • Adverse event (AE)/ SAE assessments
  • ECG: single reading
Laboratory Assessments
Patient Reported Outcomes
  • None
Study Treatment
  • None
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Month 1

Below is the schedule of assessments (SOA) for this stage of the study protocol.

Clinical and Other Assessments
  • Physical exam (Targeted)
  • HIV-associated conditions
  • Concomitant Medications
  • Adverse event (AE)/ SAE assessments
Laboratory Assessments
Patient Reported Outcomes
  • Columbia Suicidality Severity Rating Scale (C-SSRS)
Study Treatment
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Month 1 + 2 weeks

Below is the schedule of assessments (SOA) for this stage of the study protocol.

Clinical and Other Assessments
  • Physical exam (Targeted)
  • HIV-associated conditions
  • Concomitant Medications
  • Adverse event (AE)/ SAE assessments
Laboratory Assessments
Patient Reported Outcomes
  • None
Study Treatment
  • None
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Month 2

Below is the schedule of assessments (SOA) for this stage of the study protocol.

Clinical and Other Assessments
  • Physical exam (Targeted)
  • HIV-associated conditions
  • Concomitant Medications
  • Adverse event (AE)/ SAE assessments
Laboratory Assessments
Patient Reported Outcomes
  • Columbia Suicidality Severity Rating Scale (C-SSRS)
Study Treatment
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Month 3

Below is the schedule of assessments (SOA) for this stage of the study protocol.

Clinical and Other Assessments
  • Physical exam (Targeted)
  • HIV-associated conditions
  • Concomitant Medications
  • Adverse event (AE)/ SAE assessments
Laboratory Assessments
Patient Reported Outcomes
  • Columbia Suicidality Severity Rating Scale (C-SSRS)
Study Treatment
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Month 4

Below is the schedule of assessments (SOA) for this stage of the study protocol.

Clinical and Other Assessments
  • Physical exam (Targeted)
  • HIV-associated conditions
  • Concomitant Medications
  • Adverse event (AE)/ SAE assessments
Laboratory Assessments
Patient Reported Outcomes
  • Columbia Suicidality Severity Rating Scale (C-SSRS)
  • Acceptability of treatment (ACCEPT)
Study Treatment
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Month 5

Below is the schedule of assessments (SOA) for this stage of the study protocol.

Clinical and Other Assessments
  • Physical exam (Targeted)
  • HIV-associated conditions
  • Concomitant Medications
  • Adverse event (AE)/ SAE assessments
Laboratory Assessments
Patient Reported Outcomes
  • Columbia Suicidality Severity Rating Scale (C-SSRS)
Study Treatment
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Month 6

Below is the schedule of assessments (SOA) for this stage of the study protocol.

Clinical and Other Assessments
  • Height, weight (W) and BMI
  • Vital signs
  • Physical exam (Targeted)
  • HIV-associated conditions
  • Concomitant Medications
  • Adverse event (AE)/ SAE assessments
  • ECG: single reading
Laboratory Assessments
Patient Reported Outcomes
  • Columbia Suicidality Severity Rating Scale (C-SSRS)
  • Acceptability of treatment (ACCEPT)
  • HIVTSQ (status)
  • HIVTSQ (change)
  • EQ-5D 3L
Study Treatment
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Month 7

Below is the schedule of assessments (SOA) for this stage of the study protocol.

Clinical and Other Assessments
  • Physical exam (Targeted)
  • HIV-associated conditions
  • Concomitant Medications
  • Adverse event (AE)/ SAE assessments
Laboratory Assessments
Patient Reported Outcomes
  • Columbia Suicidality Severity Rating Scale (C-SSRS)
Study Treatment
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Month 8

Below is the schedule of assessments (SOA) for this stage of the study protocol.

Clinical and Other Assessments
  • Height, weight (W) and BMI
  • Vital signs
  • Physical exam (Targeted)
  • HIV-associated conditions
  • Concomitant Medications
  • Adverse event (AE)/ SAE assessments
Laboratory Assessments
Patient Reported Outcomes
  • Columbia Suicidality Severity Rating Scale (C-SSRS)
  • Acceptability of treatment (ACCEPT)
Study Treatment
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Month 9

Below is the schedule of assessments (SOA) for this stage of the study protocol.

Clinical and Other Assessments
  • Physical exam (Targeted)
  • HIV-associated conditions
  • Concomitant Medications
  • Adverse event (AE)/ SAE assessments
Laboratory Assessments
Patient Reported Outcomes
  • Columbia Suicidality Severity Rating Scale (C-SSRS)
Study Treatment
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Month 10

Below is the schedule of assessments (SOA) for this stage of the study protocol.

Clinical and Other Assessments
  • Physical exam (Targeted)
  • HIV-associated conditions
  • Concomitant Medications
  • Adverse event (AE)/ SAE assessments
Laboratory Assessments
Patient Reported Outcomes
  • Columbia Suicidality Severity Rating Scale (C-SSRS)
Study Treatment
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Month 11

Below is the schedule of assessments (SOA) for this stage of the study protocol.

Clinical and Other Assessments
  • Physical exam (Targeted)
  • HIV-associated conditions
  • Concomitant Medications
  • Adverse event (AE)/ SAE assessments
Laboratory Assessments
Patient Reported Outcomes
  • Columbia Suicidality Severity Rating Scale (C-SSRS)
Study Treatment
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Month 12

Below is the schedule of assessments (SOA) for this stage of the study protocol.

Clinical and Other Assessments
  • Height, weight (W) and BMI
  • Vital signs
  • Physical exam (Targeted)
  • HIV-associated conditions
  • Concomitant Medications
  • Adverse event (AE)/ SAE assessments
Laboratory Assessments
Patient Reported Outcomes
  • Columbia Suicidality Severity Rating Scale (C-SSRS)
  • Acceptability of treatment (ACCEPT)
Study Treatment
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Month 13

Below is the schedule of assessments (SOA) for this stage of the study protocol.

Clinical and Other Assessments
  • Physical exam (Targeted)
  • HIV-associated conditions
  • Concomitant Medications
  • Adverse event (AE)/ SAE assessments
Laboratory Assessments
Patient Reported Outcomes
  • Columbia Suicidality Severity Rating Scale (C-SSRS)
Study Treatment
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Month 14

Below is the schedule of assessments (SOA) for this stage of the study protocol.

Clinical and Other Assessments
  • Physical exam (Targeted)
  • HIV-associated conditions
  • Concomitant Medications
  • Adverse event (AE)/ SAE assessments
Laboratory Assessments
Patient Reported Outcomes
  • Columbia Suicidality Severity Rating Scale (C-SSRS)
Study Treatment
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Month 15

Below is the schedule of assessments (SOA) for this stage of the study protocol.

Clinical and Other Assessments
  • Physical exam (Targeted)
  • HIV-associated conditions
  • Concomitant Medications
  • Adverse event (AE)/ SAE assessments
Laboratory Assessments
Patient Reported Outcomes
  • Columbia Suicidality Severity Rating Scale (C-SSRS)
Study Treatment
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Month 16

Below is the schedule of assessments (SOA) for this stage of the study protocol.

Clinical and Other Assessments
  • Physical exam (Targeted)
  • HIV-associated conditions
  • Concomitant Medications
  • Adverse event (AE)/ SAE assessments
Laboratory Assessments
Patient Reported Outcomes
  • Columbia Suicidality Severity Rating Scale (C-SSRS)
Study Treatment
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Month 17

Below is the schedule of assessments (SOA) for this stage of the study protocol.

Clinical and Other Assessments
  • Physical exam (Targeted)
  • HIV-associated conditions
  • Concomitant Medications
  • Adverse event (AE)/ SAE assessments
Laboratory Assessments
Patient Reported Outcomes
  • Columbia Suicidality Severity Rating Scale (C-SSRS)
Study Treatment
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Month 18

Below is the schedule of assessments (SOA) for this stage of the study protocol.

Clinical and Other Assessments
  • Physical exam (Targeted)
  • HIV-associated conditions
  • Concomitant Medications
  • Adverse event (AE)/ SAE assessments
Laboratory Assessments
Patient Reported Outcomes
  • Columbia Suicidality Severity Rating Scale (C-SSRS)
Study Treatment
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Month 19

Below is the schedule of assessments (SOA) for this stage of the study protocol.

Clinical and Other Assessments
  • Physical exam (Targeted)
  • HIV-associated conditions
  • Concomitant Medications
  • Adverse event (AE)/ SAE assessments
Laboratory Assessments
Patient Reported Outcomes
  • Columbia Suicidality Severity Rating Scale (C-SSRS)
Study Treatment
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Month 20

Below is the schedule of assessments (SOA) for this stage of the study protocol.

Clinical and Other Assessments
  • Physical exam (Targeted)
  • HIV-associated conditions
  • Concomitant Medications
  • Adverse event (AE)/ SAE assessments
Laboratory Assessments
Patient Reported Outcomes
  • Columbia Suicidality Severity Rating Scale (C-SSRS)
Study Treatment
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Month 21

Below is the schedule of assessments (SOA) for this stage of the study protocol.

Clinical and Other Assessments
  • Physical exam (Targeted)
  • HIV-associated conditions
  • Concomitant Medications
  • Adverse event (AE)/ SAE assessments
Laboratory Assessments
Patient Reported Outcomes
  • Columbia Suicidality Severity Rating Scale (C-SSRS)
Study Treatment
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Month 22

Below is the schedule of assessments (SOA) for this stage of the study protocol.

Clinical and Other Assessments
  • Physical exam (Targeted)
  • HIV-associated conditions
  • Concomitant Medications
  • Adverse event (AE)/ SAE assessments
Laboratory Assessments
Patient Reported Outcomes
  • Columbia Suicidality Severity Rating Scale (C-SSRS)
Study Treatment
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Month 23

Below is the schedule of assessments (SOA) for this stage of the study protocol.

Clinical and Other Assessments
  • Physical exam (Targeted)
  • HIV-associated conditions
  • Concomitant Medications
  • Adverse event (AE)/ SAE assessments
Laboratory Assessments
Patient Reported Outcomes
  • Columbia Suicidality Severity Rating Scale (C-SSRS)
Study Treatment
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Month 24

Below is the schedule of assessments (SOA) for this stage of the study protocol.

Clinical and Other Assessments
  • Height, weight (W) and BMI
  • Vital signs
  • Physical exam (Targeted)
  • HIV-associated conditions
  • Concomitant Medications
  • Adverse event (AE)/ SAE assessments
  • ECG: single reading
Laboratory Assessments
Patient Reported Outcomes
  • Columbia Suicidality Severity Rating Scale (C-SSRS)
  • Acceptability of treatment (ACCEPT)
  • HIVTSQ (status)
  • EQ-5D 3L
Study Treatment
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Early Discontinuation / Withdrawal

Below is the schedule of assessments (SOA) for this stage of the study protocol.

Clinical and Other Assessments
  • Height, weight (W) and BMI
  • Vital signs
  • Physical exam (Targeted)
  • HIV-associated conditions
  • Concomitant Medications
  • Adverse event (AE)/ SAE assessments
  • ECG: single reading
  • HIVSTQ (change)
Laboratory Assessments
Patient Reported Outcomes
  • Columbia Suicidality Severity Rating Scale (C-SSRS)
  • Acceptability of treatment (ACCEPT)
  • HIVTSQ (status)
  • EQ-5D 3L
Study Treatment
  • None
Legend

1 Sex at birth, sex at study entry, current gender, race, ethnicity, duration of HIV therapy, time since HIV diagnosis and CD4+ cell count nadir will be collected
2 Month 2 only
3 Three (3) 2mL samples of frozen plasma. These samples will be used as replacement samples if primary samples are lost or arrive at the laboratory unevaluable, or for additional evaluations as required.
4 Two (2) 2mL sample of frozen plasma
5 One (1) 4mL sample of whole blood in EDTA
6 Nine (9) 10mL samples of whole blood in sodium heparin
7 Two (2) 10mL samples of whole blood in sodium heparin
8 Four (4) 10mL samples of whole blood in sodium heparin
9 A separate PGx ICF must be signed. Collection may be at any time after signing ICF, but preferably on Day 1
10 Four (4) 1 mL samples of frozen plasma
11 Two (2) 1 mL samples of frozen serum
12 Month 4 only
13 IVRS/IWRS required at all drug dispensation visits (VH3810109 and/or Cabotegravir).