Study of Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in Virologically Suppressed… (NCT05660980) | Clinical Trial Compass
RecruitingPhase 1/2
Study of Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in Virologically Suppressed Children Living With HIV-1, Two to Less Than 12 Years of Age
United States, Botswana, Brazil90 participantsStarted 2024-01-24
Plain-language summary
The purpose of the study is to evaluate the pharmacokinetics (PK), safety, tolerability, and acceptability of a long-acting injectable Cabotegravir and Rilpivirine in Virologically Suppressed Children Living with HIV-1, Two to Less Than 12 Years of Age
Who can participate
Age range2 Years – 11 Years
SexALL
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Inclusion Criteria, Step 1: Entry for Cohort 1, Cohort 2a, and Cohort 2b
* Parent or legal guardian is willing and able to provide written permission for child's study participation and, when applicable per institutional review board/ethics committee (IRB/EC) policies and procedures, child is willing and able to provide written assent for study participation.
Note: All sites must follow all applicable IRB/EC policies and procedures; for US sites, this includes single IRB (sIRB) policies and procedures.
* Age two years old to less than 12 years old at entry
* Body weight ≥10 kg and \<40 kg at entry
* At entry, 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 from two separate blood collection tubes per Sample #1 and Sample #2 requirements. Test results may be obtained from medical records or from testing performed during the study screening period
* Has been on a stable unchanged ART regimen consisting of two or more drugs from two or more antiretroviral drug classes for at least six consecutive months (defined as 180 consecutive days) prior to entry.
* Has no prior history of switching ART regimens for reasons related to treatment failure based on parent/guardian report and/or available medical records.
Note: Participants undergoing dose modifications for growth or who have switched to a new formulation …
Accumulation Ratio at week 24 and week 8 (Cohort 1, injections)
Timeframe: At week 8 and 24
10
Proportion of children who experience a drug related safety event during the CAB + RPV oral lead-in period (Cohort 1)
Timeframe: Through week 4a
11
Proportion of children who experience a grade 3 of higher adverse event during the CAB + RPV oral lead-in period (Cohort 1)
Timeframe: Through week 4a
12
Proportion of children who experience an SAE during the CAB + RPV oral lead-in period (Cohort 1)
Timeframe: Through week 4a
13
Proportion of children who experience premature permanent discontinuation study treatment due to an adverse event during the CAB + RPV oral lead-in period (Cohort 1)
Timeframe: Through week 4a
14
Proportion of children who experience a drug-related safety failure event during the 24 weeks of CAB + RPV (oral and injectable) (Cohort 1)
Timeframe: Week 4b through week 28
15
Proportion of children who experience a grade 3 or higher adverse event during the 24 weeks of CAB + RPV (oral and injectable) (Cohort 1)
Timeframe: Week 4b through week 28
16
Proportion of children who experience an SAE during the 24 weeks of CAB + RPV (oral and injectable) (Cohort 1)
Timeframe: Week 4b through week 28
17
Proportion of children who experience premature permanent discontinuation study treatment due to an adverse event during the 24 weeks of CAB + RPV (oral and injectable) (Cohort 1)