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Integrase Inhibitor and Non-Nucleoside Reverse Transcriptase Inhibitor
Cabotegravir + Rilpivirine for HIV in Children
Phase 1 & 2
Recruiting
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 44 and 48
Awards & highlights
No Placebo-Only Group
Summary
This trial evaluates the effects of long-term injectable HIV drugs on children, to measure safety, tolerability and acceptability.
Who is the study for?
This trial is for HIV-positive children aged 2 to less than 12 years, weighing between 10 and <40 kgs, with a stable ART regimen for at least six months. They must have an undetectable viral load and no history of treatment failure or resistance to certain HIV drugs. Children with bleeding disorders, needle phobia, active tuberculosis, significant heart conditions or seizures are excluded.
What is being tested?
The study tests the safety and effectiveness of oral tablets versus long-acting injectables of two HIV medications: Cabotegravir (CAB) and Rilpivirine (RPV). It aims to understand how these treatments work in young children who already have controlled HIV.
What are the potential side effects?
Possible side effects include reactions at injection sites for the injectables, potential liver issues, allergic reactions to medication components, gastrointestinal disturbances like nausea or vomiting, fatigue and headaches. The severity can vary among individuals.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at week 44 and 48
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 44 and 48
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
AUC (Cohort 1, tablets)
CL/F (Cohort 1, tablets)
Cmax (Cohort 1, tablets)
+1 moreSecondary study objectives
Child and/or parent/caregiver response to questionnaires (Cohort 2)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Cohort 2BExperimental Treatment1 Intervention
Cohort 2B: Q4W or Q8W intramuscular injection doses of CAB LA + RPV LA.
Group II: Cohort 2AExperimental Treatment2 Interventions
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.
Group III: Cohort 1Experimental Treatment2 Interventions
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)
Find a Location
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,336 Previous Clinical Trials
5,392,674 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,068 Previous Clinical Trials
2,747,617 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,936 Previous Clinical Trials
2,751,551 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 2 and 11 years old.My condition is resistant to certain HIV medications.I have had a condition where my lymphocytes grow abnormally.I have a history of cancer.My condition is resistant to certain HIV medications.I haven't had cancer in the last 5 years, except for skin cancer.I have heart problems like heart failure or irregular heartbeat.I meet the specific health conditions and risk factors required.I haven't taken any prohibited medications in the last week.I have been on the same HIV medication for at least 6 months.My weight is between 10 and 40 kilograms.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 2A
- Group 2: Cohort 1
- Group 3: Cohort 2B
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.