Study of Cabotegravir and Rilpivirine in Children with HIV-1
This study is looking at two forms of medication, oral tablets and long-acting injections, for children aged 2 to less than 12 years old who are living with HIV-1 and whose virus is well-controlled (virologically suppressed). The medications being studied are Cabotegravir and Rilpivirine. The main goal is to understand how the body processes these drugs (pharmacokinetics), how safe they are, how well children tolerate them, and if they are acceptable to use. The study aims to help determine the right doses for different weight groups. Currently, the study is planning to enroll 90 participants.
- Study design
- This is a Phase I/II, multi-center, open-label study, meaning both the researchers and participants will know which treatment is being given. It is designed to evaluate the safety, tolerability, acceptability, and how the body handles the drugs.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants may enter a Study Safety Extension (SSE) period after the study if they cannot get the injectable medications from other sources, during which safety information will be collected.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05660980
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
Recruiting
PHASE1Ages 2–11InterventionalTreatmentNational Institute of Allergy and Infectious Diseases (NIAID)Government-funded
~90 participants
Updated 2026-05-19 on ClinicalTrials.gov
What's tested:Once daily CAB tablet + RPV tabletLong acting CAB injectable + long acting RPV injectable
At a glance
Recruiting sites
12 of 12 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
AUC (Cohort 1, tablets)
Measured over At week 2
+16 more outcomes measured
Conditions
Where it's being run
12 sites across 8 statesBotswana2
Brazil2
South Africa2
Thailand2
Georgia1
Tennessee1
KwaZulu-Natal1
Bangkoknoi1
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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.
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.
From a specimen collected less than six months (defined as within 179 days) prior to entry, has at least one of the following documented plasma HIV-1 RNA results:
\<50 copies/mL, or
less than the lower limit of detection of the assay
From a specimen collected in the 6-18 months (defined as 180 to 545 days) prior to entry, has at least one of the following documented plasma HIV-1 RNA results:
\<50 copies/mL, or
less than the lower limit of detection of the assay
At screening, a documented plasma HIV-1 RNA \<50 copies/mL.
Has normal, Grade 1, or Grade 2 results for all the following laboratory tests at screening (i.e., within 28 days prior to entry) based on grading per the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events:
AST (\<5.0 x ULN)
ALT (\<5.0 x ULN)
Total bilirubin (\<2.6 x ULN)
Lipase (\<3 x ULN)
Estimated glomerular filtration rate (eGFR; ≥60 ml/min/1.73 m2)
Platelets (≥50,000 cells/mm3 or ≥50.00 x 109 cells/L)
Hemoglobin (≥8.5 g/dL or ≥5.25 mmol/L)
Neutrophils (≥600 cells/mm3)
Has no evidence of chronic hepatitis B infection based on hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), and hepatitis B surface antibody (HBsAb) testing at screening; any of the following three combinations of test results are acceptable for inclusion:
HBsAg negative, HBcAb negative, HBsAb negative
HBsAg negative, HBcAb negative, HBsAb positive
HBsAg negative, HBcAb positive, HBsAb positive
At screening, has a mean QTc interval (based upon a triplicate reading) less than or equal to 450 msec based on an electrocardiogram (ECG) automated machine readout or calculated using the Fridericia formula.
For female participants of childbearing potential, not pregnant based upon negative blood or urine pregnancy test at entry. Childbearing potential is defined as nine years of age or older and:
Having reached menarche or
Engaging in sexual activity (self-reported) that could lead to pregnancy
For female participants of childbearing potential who are engaging in sexual activity (self-reported) that could lead to pregnancy, at entry, currently using at least one allowable highly effective method of contraception and agrees to use at least one allowable highly effective method of contraception throughout study participation and for at least 30 days after last oral product use and 48 weeks after last injectable study product use.
Surgical sterilization (i.e., hysterectomy, bilateral oophorectomy, tubal ligation, or salpingectomy)
Contraceptive intrauterine device or intrauterine system
Subdermal contraceptive implant
Progestogen injections
Combined estrogen and progestogen oral contraceptive pills
Percutaneous contraceptive patch
Contraceptive vaginal ring
Currently enrolled as a participant in Step 1.
Has normal, Grade 1, or Grade 2 results from all of the following laboratory test results based upon specimens collected at the Week 4a study visit or from confirmatory repeat testing of Week 4a study visit laboratory tests:
AST (\<5.0 x ULN)
ALT (\<5.0 x ULN)
Lipase (\< 3 x ULN)
Estimated glomerular filtration rate (eGFR; ≥60 ml/min/1.73 m2))
Platelets (≥50,000 cells/mm3 or ≥50.00 x 109 cells/L)
Hemoglobin (≥8.5 g/dL or ≥5.25 mmol/L)
CK (\<10 x ULN)
For female participants of childbearing potential not pregnant based upon negative blood or urine pregnancy test at the Week 4b study visit.
Assessed by the IoR or designee as sufficiently adherent to study products in Step 1 to permit an adequate evaluation of safety and tolerability as part of the oral lead in phase prior to entry into the injection phase.
18 years of age or older
Able and willing to provide written informed consent consistent with site IRB/EC policies and procedures
Caregiver, defined as a biological parent, legal guardian, or other person who provides significant emotional, psychological, and/or physical care to a child enrolled in IMPAACT 2036, based on self-report
Exclusion
Within 6 months prior to entry, any HIV-1 RNA value \>400 copies/mL OR two consecutive "viral blips," defined as an HIV-1 RNA value ≥50 copies/mL but ≤400 copies/mL.
As determined by the IoR or designee, and based on available medical records, known or suspected resistance to NNRTIs.
As determined by the IoR or designee, and based on available medical records, known or suspected resistance to INSTIs.
Ongoing congestive heart failure, symptomatic arrhythmia, or any current clinically significant cardiac disease, as determined by the IoR or designee, and based on available medical records.
Has any of the following, as determined by the IoR or designee based on participant/parent/guardian report and available medical records:
Current hepatitis C infection
Current clinically significant hepatic disease
Current or anticipated need for chronic anti-coagulation
History of known or suspected bleeding disorder, including a history of prolonged bleeding
History of sensitivity to heparin or heparin-induced thrombocytopenia, as determined by the IoR or designee, based on available medical records
Risk factors for Torsade de Pointes (e.g., heart failure, hypokalemia, hypomagnesemia)
Known or suspected allergy to study product components.
Known phobia to needles
More than one seizure within one year (defined as within 365 days) prior to entry, or unstable or poorly controlled seizure disorder, as determined by the IoR or designee, and based on available medical records.
Has the following combination of laboratory test results at screening (i.e., from specimens collected within 28 days prior to entry): ALT greater than or equal to 3 x ULN and total bilirubin greater than or equal to 1.5 x ULN and direct bilirubin greater than 35% of total bilirubin.
At entry, known active tuberculosis infection, as determined by the IoR or designee based on participant/parent/guardian report and available medical records.
At entry, any ongoing pancreatitis as determined by the IoR or designee based on participant/parent/guardian report and available medical records.
At entry, has symptoms suggestive of active coronavirus disease 2019 (COVID-19) or test results or contacts that require quarantine per local clinical practice, public health, and/or infection control guidelines as determined by the IoR or designee based on participant/parent/guardian report and available medical records.
Receipt of any prohibited medication within 7 days prior to entry, with the exception of antiviral agents that are part of the participant's ART regimen, as determined by the site investigator based on participant/parent/guardian report and available medical records
Any past or current exposure to CAB LA or RPV LA
At entry, based on physical examination, has a current inflammatory skin condition that compromises the safety of intramuscular injections, as determined by the IoR or designee.
At entry, based on physical examination, has a dermatological condition overlying the buttock or upper thigh region, which, in the IoR or designee's opinion, may interfere with the interpretation of injection site reactions.
Enrolled in another clinical trial of an investigational agent, device, or vaccine.
Has any documented or suspected clinically significant medical or psychiatric condition or any other condition or social circumstance that, in the opinion of the site investigator, would make participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Has permanently discontinued oral study product.
Occurrence of any grade 3 or higher adverse event assessed as related to study product during Step 1.
Any other condition or social circumstance situation that, in the opinion of the IoR or designee, would make continued study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Any condition or social circumstance situation that, in the opinion of the IoR or designee, would make study participation unsafe for the caregiver or the child study participant, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
What this trial measures
- AUC (Cohort 1, tablets)At week 2
Area under the curve from start of dose to 8 hours post dose
- CL/F (Cohort 1, tablets)At week 2
apparent clearance from start of dose to 8 hours post dose
- Cmax (Cohort 1, tablets)At week 2
Peak concentration from start of dose to 8 hours post dose
- Tmax (Cohort 1, tablets)At week 2
Time of maximal concentration from start of dose to 8 hours post dose
- Pre-dose concentrations (C0) (Cohort 1, tablets)At week 2
- Week 5 concentrations (C5WK) (Cohort 1, injections)Through week5
- Week 12 concentrations (C12WK) (Cohort 1, injections)Through week 12
- Trough concentrations (Ct) prior to IM doses through Week 24 (Cohort 1, injections)Through week 24
- Accumulation Ratio at week 24 and week 8 (Cohort 1, injections)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)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)Through week 4a
- Proportion of children who experience an SAE during the CAB + RPV oral lead-in period (Cohort 1)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)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)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)Week 4b through week 28
- Proportion of children who experience an SAE during the 24 weeks of CAB + RPV (oral and injectable) (Cohort 1)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)Week 4b through week 28