More Options for Children and Adolescents (MOCHA): Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in HIV-Infected Children and Adolescents

Inclusion Criteria: Cohort 1 Step 1, Cohort 2 Step 3, and Cohort 2 Step 5

All the following criteria must be met for inclusion of any adolescent participant in Step 1 of Cohort 1, or in Step 3 of Cohort 2, unless otherwise noted:

• At enrollment, body weight greater than or equal to 35 kg (77 lbs)
• Note: For Cohort 1 Step 2 participants, body weight will not be exclusionary for enrollment into Cohort 2 Step 3, if otherwise eligible.
• For Cohort 1, at enrollment, body mass index (BMI) less than or equal to 31.5 kg/m^2
• At enrollment, willing and able to comply with the study visit schedule and other study requirements, as determined by the site investigator or designee
• Confirmed HIV-1-infection based on documented testing of two samples collected at different time points. More information on this criterion can be found in the protocol.
• For at least 3 consecutive months (defined as 90 consecutive days) prior to screening, and prior to enrollment, has been on stable unchanged cART consisting of 2 or more drugs from 2 or more classes of antiretroviral drugs, ascertainment of this criterion may be based on parent or guardian report only, but available medical records should also be reviewed in relation to this criterion.
• Note: Participants undergoing dose modifications to their antiretroviral regimen for growth or who are switching medication formulation(s) are considered to be on a stable cART.
• Has at least one documented plasma HIV-1 RNA less than the lower limit of detection of the assay from a specimen collected 6 to 12 months (defined as 180 to 365 days) prior to entry. OR

Has at least one documented plasma HIV-1 RNA less than the lower limit of detection of the assay from a specimen collected less than 6 months (defined as within 179 days) prior to entry and at least one documented plasma HIV-1 RNA result less than the lower limit of detection of the assay from a specimen collected in the 12-18 months (defined as 365 to 545 days) prior to entry.

OR

For Cohort 1 participants enrolling to Cohort 2, has documented plasma HIV-1 RNA results less than the lower limit of detection of the assay from all indicated Cohort 1 study visits with their Cohort 1 Week 16 visit completed within 28 days prior to Cohort 2 entry.

• At screening, has Grade 2 or lower of all the following laboratory test results:
• Alanine transaminase (ALT) (u/l)
• Lipase (u/l)
• Estimated creatinine clearance (CrCl; Schwartz formula mL/min/1.73m^2)
• Platelets (cells/mm^3)
• Hemoglobin (g/dL)
• AST (u/l)
• Absolute Neutrophil Count (cells/mm3)
• See study protocol for guidance on severity grading. Laboratory tests may be repeated during the study screening period, with the latest result used for eligibility determination.
• At screening, is on an atazanavir-containing (ATV) cART regimen, and has total bilirubin less than or equal to 1.5 mg/dL or normal direct bilirubin
• At screening, has documented plasma HIV-1 RNA less than 50 copies/mL
• At screening, mean value of Q-T interval (QTc) interval (automated machine readout or calculated using either Bazett or Fredericia) on ECG performed in triplicate, less than or equal to 500 msec.
• For females, has a negative (blood or urine) human chorionic gonadotropin (hCG) laboratory test result at entry
• For females of childbearing potential, at entry, currently using at least one allowable effective method of contraception, and agrees to use at least one allowable effective method of contraception throughout study participation, for at least 30 days after discontinuation of oral study product, and for at least 48 weeks after discontinuation of CAB LA and/or RPV LA, and intending to delay any planned pregnancies until 30 days after last oral study product use or until 48 weeks after last injectable study product use.
• Note: See study protocol for details regarding contraceptive counseling, a list of the allowed effective contraceptive methods for this study, and the definition of a female of childbe