NCT05660980 · National Institute of Allergy and Infectious Diseases (NIAID)
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
What this study is about
The purpose of the study is to evaluate the how the drug moves through the body (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
View original scientific description
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
Interventions
DRUG
Once daily CAB tablet + RPV tablet
Tablet
DRUG
Long acting CAB injectable + long acting RPV injectable
Injectable
DRUG
Long acting CAB injectable + long acting RPV injectable
Injectable
Primary outcome measures
AUC (Cohort 1, tablets)
Time frame: At week 2
Area under the curve from start of dose to 8 hours post dose
CL/F (Cohort 1, tablets)
Time frame: At week 2
apparent clearance from start of dose to 8 hours post dose
Cmax (Cohort 1, tablets)
Time frame: At week 2
Peak concentration from start of dose to 8 hours post dose
Tmax (Cohort 1, tablets)
Time frame: At week 2
Time of maximal concentration from start of dose to 8 hours post dose
Pre-dose concentrations (C0) (Cohort 1, tablets)
Time frame: At week 2
Week 5 concentrations (C5WK) (Cohort 1, injections)
Time frame: Through week5
Week 12 concentrations (C12WK) (Cohort 1, injections)
Time frame: Through week 12
Trough concentrations (Ct) prior to IM doses through Week 24 (Cohort 1, injections)
Time frame: Through week 24
Accumulation Ratio at week 24 and week 8 (Cohort 1, injections)
Time frame: At week 8 and 24
Proportion of children who experience a drug related safety event during the CAB + RPV oral lead-in period (Cohort 1)
Time frame: Through week 4a
Proportion of children who experience a grade 3 of higher adverse event during the CAB + RPV oral lead-in period (Cohort 1)
Time frame: Through week 4a
Proportion of children who experience an SAE during the CAB + RPV oral lead-in period (Cohort 1)
Time frame: Through week 4a
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)
Time frame: Through week 4a
Proportion of children who experience a drug-related safety failure event during the 24 weeks of CAB + RPV (oral and injectable) (Cohort 1)
Time frame: Week 4b through week 28
Proportion of children who experience a grade 3 or higher adverse event during the 24 weeks of CAB + RPV (oral and injectable) (Cohort 1)
Time frame: Week 4b through week 28
Proportion of children who experience an SAE during the 24 weeks of CAB + RPV (oral and injectable) (Cohort 1)
Time frame: Week 4b through week 28
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)
Time frame: Week 4b through week 28
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 kgs and \<40 kgs 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
Where
- Atlanta, Georgia
- Memphis, Tennessee
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 19, 2026 · Source of record for eligibility and locations