Actively Recruiting
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
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-05-11
90
Participants Needed
12
Research Sites
270 weeks
Total Duration
On this page
Sponsors
N
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Parent or legal guardian willing and able to provide written permission; child willing and able to provide assent if applicable
- Age between 2 years and less than 12 years at entry
- Body weight at least 10 kg and less than 40 kg at entry
- Willing and able to comply with study visits and requirements
- Confirmed HIV-1 infection from documented testing
- On a stable, unchanged ART regimen with two or more drugs for at least six consecutive months prior to entry
- No prior history of ART regimen switch due to treatment failure
- Documented plasma HIV-1 RNA less than 50 copies/mL or below assay detection limit within 6 months prior to entry
- Documented plasma HIV-1 RNA less than 50 copies/mL or below assay detection limit within 6 to 18 months prior to entry
- HIV-1 RNA less than 50 copies/mL at screening
- Normal, Grade 1, or Grade 2 lab results for AST, ALT, total bilirubin, lipase, eGFR, platelets, hemoglobin, and neutrophils at screening
- No evidence of chronic hepatitis B infection with acceptable test result combinations
- Mean QTc interval less than or equal to 450 msec at screening
- For females of childbearing potential, not pregnant at entry and using highly effective contraception if sexually active
- Assessed as adherent to oral study products to proceed to injection phase
- Caregivers 18 years or older, able and willing to provide informed consent, and provide significant care to participant
You will not qualify if you...
- HIV-1 RNA over 400 copies/mL or two consecutive viral blips within 6 months prior to entry
- Known or suspected resistance to NNRTIs or INSTIs
- Ongoing congestive heart failure, symptomatic arrhythmia, or significant cardiac disease
- Current hepatitis C infection or significant hepatic disease
- Current or anticipated need for chronic anticoagulation or bleeding disorders
- History of heparin sensitivity or heparin-induced thrombocytopenia
- Risk factors for Torsade de Pointes
- Known or suspected allergy to study product components
- Known phobia to needles
- More than one seizure within one year or unstable seizure disorder
- Laboratory results showing ALT ≥3 x ULN, total bilirubin ≥1.5 x ULN, and direct bilirubin >35% of total bilirubin
- Active tuberculosis infection at entry
- Ongoing pancreatitis at entry
- Symptoms suggestive of active COVID-19 or required quarantine
- Use of prohibited medication within 7 days before entry, except ART antiviral agents
- Past or current exposure to CAB LA or RPV LA
- Inflammatory skin or dermatological conditions compromising injection safety or interpretation
- Participation in another clinical trial of investigational agent, device, or vaccine
- Any medical or psychiatric condition or social circumstance making participation unsafe or complicating outcomes
- Permanent discontinuation of oral study product or grade 3+ related adverse event during oral phase for injection phase continuation
- Caregiver condition or circumstance making participation unsafe or complicating outcomes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
Site 5030, Emory University School of Medicine NICHD CRS
Atlanta, Georgia, United States, 30322
Actively Recruiting
2
Site 6501, St. Jude Children's Research Hospital CRS
Memphis, Tennessee, United States, 38105
Actively Recruiting
3
Site 12701, Gaborone CRS
Gaborone, Botswana
Actively Recruiting
4
Site 12702, Molepolole CRS
Gaborone, Botswana
Actively Recruiting
5
Site 5073, SOM Federal University Minas Gerais Brazil NICHD CRS
Belo Horizonte, Brazil, 30130-100
Actively Recruiting
6
CRS 5071, Instituto de Puericultura e Pediatria Martagao Gesteira Clinical Research Site
Rio de Janeiro, Brazil, 21941-590
Actively Recruiting
7
Site 30300 Umlazi CRS Site
Umlazi, KwaZulu-Natal, South Africa, 4066
Actively Recruiting
8
CRS 8052, Soweto IMPAACT
Johannesburg, South Africa, 1864
Actively Recruiting
9
Site 8051, Wits RHI Shandukani Research Centre CRS
Johannesburg, South Africa, 2001
Actively Recruiting
10
Siriraj Hospital, Mahidol University NICHD CRS (Site #5115)
Bangkok, Bangkoknoi, Thailand, 10700
Actively Recruiting
11
CRS 31784, Chiang Mai University HIV Treatment CRS
Chiang Mai, Thailand, 50202
Actively Recruiting
12
Site 5116, Chiangrai Prachanukroh Hospital NICHD CRS
Chiang Rai, Thailand, 57000
Actively Recruiting
Research Team
R
Rachel Scheckter
CONTACT
I
IMPAACT Clinicaltrials.gov Coordinator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here