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HIV-1-infectionPhase 1/2NCT05660980

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

A Phase 1/2 study testing Once daily CAB tablet + RPV tablet and Long acting CAB injectable + long acting RPV injectable in people with HIV-1-infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 12 sites in 5 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 2 to 11 years
Conditions the study is for
HIV-1-infection
What is being tested?
Once daily CAB tablet + RPV tablet and Long acting CAB injectable + long acting RPV injectable
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
12 sitesin 5 countries
Study dates
24 Jan 2024to 31 Mar 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 11 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Parents/caregivers of participants will be considered for enrollment to complete quantitative behavioral surveys and/or qualitative in-depth interviews (IDIs), as indicated in the SoE. One parent/caregiver per participant should be enrolled to complete all behavioral assessments, including the IDI, when applicable. Informed consent for parent/caregiver enrollment should be obtained at the entry visit, after the child participant's eligibility has been confirmed, and may be completed at a later date, if necessary. However, parent/caregiver consent must occur prior to any study assessments being conducted. The enrolled caregiver may be the different than the parent or legal guardian who provided written permission for the child to participate. If, at any point the enrolled parent/caregiver for a given participant withdraws from the study or is unable to complete remaining study assessments for any reason, they may be replaced.
  • Caregivers must meet the following criteria to be eligible to enroll in IMPAACT 2036:
  • 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 Criteria, Step 1: Entry for Cohort 1, Cohort 2a, and Cohort 2b
Show all 39Show fewer
  • Potential participants must be excluded from the study if any of the conditions specified below are identified during the screening period (i.e., within 28 days prior to study entry). The screening period begins when parental permission and informed assent (if applicable) are obtained and ends immediately prior to enrollment. For criteria involving a potential participant's medical history, it is expected that each exclusionary condition will be assessed at screening and subsequently reviewed and confirmed on the day of study entry, prior to enrollment. In these criteria, "at entry" is used to refer to the day of enrollment in the study
  • 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.
  • Note: Prior receipt of NNRTIs for prophylaxis or treatment is not exclusionary
  • 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.
  • Note: Potential participants with symptoms suggestive of active COVID-19, test results, and/or contacts that require quarantine may resume screening (or be re-screened) after symptoms have resolved and applicable quarantine requirements have been completed.
  • 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
  • Note: Medications and vaccines approved for emergency use (e.g., COVID vaccines) that do not appear in the IMPAACT 2036 Prohibited and Precautionary Medications listing are not exclusionary may be administered as per standard of care.
  • 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.
  • Exclusion Criteria, Step 2: Continuation for Cohort 1 and Cohort 2a to injection phase
  • Participants in Cohort 1 or Cohort 2a who meet any of the following criteria will be excluded from Step 2:
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

12 sites in 5 countries.

12 sites in 5 countries

South Africa3 sites

  • CRS 8052, Soweto IMPAACT CRS

    Johannesburg, 1862

  • Site 8051, Wits RHI Shandukani Research Centre CRS

    Johannesburg, 2001

  • Site 30300, Umlazi CRS

    Umlazi, KwaZulu-Natal, 4066

Other trials in South Africa

Thailand3 sites

  • Siriraj Hospital, Mahidol University NICHD CRS (Site #5115)

    Bangkok, Bangkoknoi, 10700

  • CRS 31784, Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS

    Chiang Mai, 50200

  • Site 5116, Chiangrai Prachanukroh Hospital NICHD CRS

    Chiang Rai, 57000

Other trials in Thailand

United States2 sites

  • Site 5030, Emory University School of Medicine NICHD CRS

    Atlanta, Georgia, 30322

  • Site 6501, St. Jude Children's Research Hospital CRS

    Memphis, Tennessee, 38105

Other trials in United States

Botswana2 sites

  • Site 12701, Gaborone CRS

    Gaborone

  • Site 12702, Molepolole CRS

    Molepolole

Other trials in Botswana

Brazil2 sites

  • Site 5073, School of Medicine, Federal University of Minas Gerais

    Belo Horizonte, 30.130-100

  • CRS 5071, Instituto de Puericultura e Pediatria Martagao Gesteira - UFRJ NICHD CRS

    Rio de Janeiro, 21941-912

Other trials in Brazil

About this study

Official title: Phase I/II Study of the Safety, Tolerability, Acceptability, and Pharmacokinetics 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

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

Read the detailed description

This is a Phase I/II, multicenter, open-label, non-comparative study to evaluate the safety, tolerability, acceptability, and PK of oral CAB and oral RPV followed by long-acting injectable CAB (CAB LA) and long-acting injectable RPV (RPV LA) to propose the weight-band dosing in virologically suppressed children living with HIV-1 aged two to less than 12 years. The study will also assess the long-acting injectable regimen with and without an oral lead-in period in the same study population.

Following completion of the study, if it is not possible for participants to access injections of CAB LA and RPV LA from non-study sources all participants may enter a Study Safety Extension (SSE) period. During the SSE period ongoing safety information to monitor for toxicities will be collected.

Conditions
HIV-1-infection
Being tested
Once daily CAB tablet + RPV tablet, Long acting CAB injectable + long acting RPV injectable

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Once daily CAB tablet + RPV tabletDrug

    Tablet

  • Long acting CAB injectable + long acting RPV injectableDrug

    Injectable

  • Long acting CAB injectable + long acting RPV injectableDrug

    Injectable

Study groups in NCT05660980
Study groupRoleWhat they receive
Cohort 1ExperimentalCohort 1 will receive Once daily oral CAB + oral RPV through the Week 4b visit, followed by intramuscular injection doses of CAB LA + RPV LA every four weeks (Q4W dosing regimen) or every eight weeks (Q8W dosing regimen)
Receives: Drug: Once daily CAB tablet + RPV tablet; Drug: Long acting CAB injectable + long acting RPV injectable
Cohort 2AExperimentalCohort 2A: Once daily doses of oral CAB + oral RPV through the Week 4b visit, followed by Q4W or Q8W intramuscular injection doses of CAB LA + RPV LA.
Receives: Drug: Once daily CAB tablet + RPV tablet; Drug: Long acting CAB injectable + long acting RPV injectable
Cohort 2BExperimentalCohort 2B: Q4W or Q8W intramuscular injection doses of CAB LA + RPV LA.
Receives: Drug: Long acting CAB injectable + long acting RPV injectable

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AUC (Cohort 1, tablets)

    Area under the curve from start of dose to 8 hours post dose

    Measured: At week 2

  2. CL/F (Cohort 1, tablets)

    apparent clearance from start of dose to 8 hours post dose

    Measured: At week 2

  3. Cmax (Cohort 1, tablets)

    Peak concentration from start of dose to 8 hours post dose

    Measured: At week 2

  4. Tmax (Cohort 1, tablets)

    Time of maximal concentration from start of dose to 8 hours post dose

    Measured: At week 2

  5. Pre-dose concentrations (C0) (Cohort 1, tablets)

    Measured: At week 2

  6. Week 5 concentrations (C5WK) (Cohort 1, injections)

    Measured: Through week5

  7. Week 12 concentrations (C12WK) (Cohort 1, injections)

    Measured: Through week 12

  8. Trough concentrations (Ct) prior to IM doses through Week 24 (Cohort 1, injections)

    Measured: Through week 24

  9. Accumulation Ratio at week 24 and week 8 (Cohort 1, injections)

    Measured: 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)

    Measured: 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)

    Measured: Through week 4a

  12. Proportion of children who experience an SAE during the CAB + RPV oral lead-in period (Cohort 1)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: Week 4b through week 28

Secondary outcomes (28)

  1. Accumulation ratios Wk 24:Wk 8 and Wk 48: Wk 8 (Cohort 2a), Wk 20:Wk4 and Wk 44: Wk 4 (Cohort 2b

    Measured: At week 8, 48 and 72

  2. Ct prior to IM doses through Week. 24 and Week. 48 (Cohort 2a)

    Measured: At Week. 24 and Week. 48

  3. Ct prior to IM doses through Wk. 20 and Wk. 44 (Cohort 2b)

    Measured: At week 20 and 44

  4. Proportion of children who experience a drug-related safety failure event through Weeks 48 and 72 of CAB + RPV (oral and injectable) (Cohort 1)

    Measured: Through week 48 and 72

  5. Proportion of children who experience a grade 3 or higher adverse event through Weeks 48 and 72 of CAB + RPV (oral and injectable) (Cohort 1)

    Measured: Through week 48 and 72

  6. Proportion of children who experience an SAE through Weeks 48 and 72 of CAB + RPV (oral and injectable) (Cohort 1)

    Measured: Through week 48 and 72

  7. Proportion of children who experience premature permanent discontinuation study treatment due to an adverse event through Weeks 48 and 72 of CAB + RPV (oral and injectable) (Cohort 1)

    Measured: Through week 48 and 72

  8. Proportion of children who have HIV-1 RNA <50 and ≥50, copies/ml at Weeks 24, 48, and 72 using the FDA Snapshot algorithm (Cohort 1)

    Measured: At weeks 24, 48 and 72

  9. Proportion of children who have HIV-1 RNA <200 and ≥200 copies/ml at Weeks 24, 48, and 72 using the FDA Snapshot algorithm (Cohort 1)

    Measured: At weeks 24, 48 and 72

  10. Proportion of children with confirmed virologic failure at Weeks 24, 48 and 72 while on CAB + RPV (Cohort 1)

    Measured: At weeks 24, 48 and 72

  11. Child and/or parent/caregiver responses to questionnaires about CAB or RPV side effects, pain associated with injections, and injection site reactions at Weeks 24, 48, and 72 (Cohort 1)

    Measured: At Weeks 24, 48, and 72

  12. Child and/or parent/caregiver reported attitudes about CAB or RPV, including willingness to use at Weeks 24, 48, and 72 (Cohort 1)

    Measured: At weeks 24, 48 and 72

  13. Proportion of participants who had genotypic and phenotypic resistance to CAB or RPV among children who experience virologic failure while on CAB + RPV (Cohort 1)

    Measured: Through week 72

  14. Median for CD4 count and percentage at Weeks 24, 48 and 72 (Cohort 1)

    Measured: At weeks 24, 48 and 72

  15. Median change from baseline CD4 count and percentage at Weeks 24, 48 and 72 (Cohort 1)

    Measured: At weeks 24, 48 and 72

  16. Child and/or parent/caregiver response to questionnaires (Cohort 2)

    about CAB or RPV side effects, pain associated with injections and injection site reactions for children who are on 48 weeks of CAB+RPV(oral and injectable) OR 44 weeks of CAB LA+RPV LA (injectable)

    Measured: at week 44 and 48

  17. Child and/or parent/caregiver reported attitudes about CAB (Cohort 2) or RPV, including willingness to use for children who are on 48 weeks of CAB + RPV (oral and injectable) OR 44 weeks of CAB LA + RPV LA (injectable)

    Measured: At week 44 and 48

  18. Proportion of children who experience a drug-related safety failure event during the 48 weeks of CAB + RPV (oral and injectable) OR the 44 weeks of CAB LA + RPV LA (injectable) (Cohort 2)

    Measured: At week 44 and 48

  19. Proportion of children who experience a grade 3 or higher adverse event during the 48 weeks of CAB + RPV (oral and injectable) OR the 44 weeks of CAB LA + RPV LA (injectable) (Cohort 2)

    Measured: At week 44 and 48

  20. Proportion of children who experience an SAE during the 48 weeks of CAB + RPV (oral and injectable) OR the 44 weeks of CAB LA + RPV LA (injectable) (Cohort 2)

    Measured: At week 44 and 48

  21. Proportion of children who experience premature permanent discontinuation study treatment due to an adverse event during the 48 weeks of CAB + RPV (oral and injectable) OR the 44 weeks of CAB LA + RPV (Cohort 2) LA (injectable)

    Measured: At week 44 and 48

  22. Proportion of children who have HIV-1 RNA <50 and ≥50, copies/ml using the FDA Snapshot algorithm for children who are on 48 weeks of CAB + RPV (oral and injectable) OR 44 weeks of CAB LA + RPV LA (injectable) (Cohort 2)

    Measured: At week 44 and 48

  23. Proportion of children who have HIV-1 RNA <200 and ≥200 copies/ml using the FDA Snapshot algorithm for children who are on 48 weeks of CAB + RPV (oral and injectable) OR 44 weeks of CAB LA + RPV LA (injectable) (Cohort 2)

    Measured: At week 44 and 48

  24. Proportion of children with confirmed virologic failure while on treatment for children who are on 48 weeks of CAB + RPV (oral and injectable) OR 44 weeks of CAB LA + RPV LA (injectable) (Cohort 2)

    Measured: At week 44 and 48

  25. Median and Interquartile Range for CD4 count and percentage for children who are on 48 weeks of CAB + RPV (oral and injectable) OR 44 weeks of CAB LA + RPV LA (injectable) (Cohort 2)

    Measured: At week 44 and 48

  26. Median and Interquartile Range change from baseline CD4 count and percentage for children who are on 48 weeks of CAB + RPV (oral and injectable) OR 44 weeks of CAB LA + RPV LA (injectable) (Cohort 2)

    Measured: At week 44 and 48

  27. Proportion of participants who had genotypic and phenotypic resistance to CAB and RPV among children who experience virologic failure while on 48 weeks of CAB + RPV (oral and injectable) OR while on 44 weeks of CAB LA + RPV LA (injectable) (Cohort 2)

    Measured: At week 44 and 48

  28. LA dosing: Ct prior to IM doses at Wk. 48 and Wk. 72 and accumulation ratios (Wk. 48:Wk. 8 and Wk. 72:Wk. 8) (Cohort 1)

    Measured: At week 8 and 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2022
  2. Study start24 Jan 2024
  3. Primary completion27 Oct 2026
  4. Study completion31 Mar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05660980
Sponsor's protocol ID
IMPAACT 2036
Other IDs
DAIDS Study ID
Status last verified
Nov 2026
First submitted
13 Dec 2022
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie results in the publication, after deidentification.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Once daily CAB tablet + RPV tablet and Long acting CAB injectable + long acting RPV injectable in people with HIV-1-infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 12 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 39 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in South Africa, Thailand, United States, Botswana, Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUC (Cohort 1, tablets) (time frame: At week 2). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05660980.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

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