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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT05660980
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • HIV-1-infection

Eligibility Criteria

Sex
ALL
Age
2 Years - 11 Years
Healthy Volunteers
Not accepted

Interventions

  • Once daily CAB tablet + RPV tablet — DRUG
    Tablet
  • Long acting CAB injectable + long acting RPV injectable — DRUG
    Injectable
  • Long acting CAB injectable + long acting RPV injectable — DRUG
    Injectable

Study Details

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

Key Dates

Start date
Jan 24, 2024
Status verified
May 2026
Primary completion
Oct 22, 2026
Completion
Mar 31, 2029

Study Design

Enrollment
90 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    Cohort 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)
  • Experimental: Cohort 2A
    Cohort 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.
  • Experimental: Cohort 2B
    Cohort 2B: Q4W or Q8W intramuscular injection doses of CAB LA + RPV LA.

Primary Outcome Measure

AUC (Cohort 1, tablets) [ Time Frame: At week 2 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Site 5030, Emory University School of Medicine NICHD CRSAtlantaGeorgia30322
Andrés Camacho-Gonzalez, MD
[email protected]
404-727-5642
Site 6501, St. Jude Children's Research Hospital CRSMemphisTennessee38105
Aditya Gaur
[email protected]
901-595-2862

Find similar trials in Atlanta, GA

By research site
Site 5030, Emory University School of Medicine NICHD CRS· Atlanta, GASite 6501, St. Jude Children's Research Hospital CRS· Memphis, TN

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