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Integrase Inhibitor and Non-Nucleoside Reverse Transcriptase Inhibitor

Cabotegravir + Rilpivirine for HIV in Children

Q: Is the recruitment process for this trial open to individuals aged 45 or older?

To be eligible for this clinical trial, participants must fall within the 2 to 11 age bracket. For those under 18 years old and above 65, there are 19 studies and 86 studies respectively.

Q: For what type of individuals is eligibility for this investigation applicable?

Eligible candidates for this study must have <a href="https://www.withpower.com/clinical-trials/hiv">HIV</a>-1, be between 2 and 11 years old, and the total recruitment goal is 90 participants.

Q: Is this medical research currently recruiting participants?

According to clinicaltrials.gov, this research investigation is not currently taking in volunteers. It was first listed on May 1st 2023 and last revised on December 13th 2022; however, there are presently an additional 109 trials recruiting participants.

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 weeks 24, 48 and 72

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 weeks 24, 48 and 72

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at weeks 24, 48 and 72

This trial's timeline: 3 weeks for screening, Varies for treatment, and at weeks 24, 48 and 72 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

AUC (Cohort 1, tablets)

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

CL/F (Cohort 1, tablets)

+14 more

Secondary outcome measures

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

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)

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

+25 more

Other outcome measures

CAB and RPV concentrations 8 to 48 weeks following final IM dose

PO dosing: Wk. 2 AUC, CL/F, Cmax, Tmax, and pre-dose concentrations (C0) by administration mode

Proportion of children who experience a drug-related safety failure event through 48 weeks following permanent discontinuation of CAB LA + RPV LA

+2 more

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)

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor

3,270 Previous Clinical Trials

5,485,147 Total Patients Enrolled

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH

1,965 Previous Clinical Trials

2,672,707 Total Patients Enrolled

National Institute of Mental Health (NIMH)NIH

2,786 Previous Clinical Trials

2,689,677 Total Patients Enrolled

Media Library

Cabotegravir and Rilpivirine (Integrase Inhibitor and Non-Nucleoside Reverse Transcriptase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05660980 — Phase 1 & 2

HIV Research Study Groups: Cohort 2A, Cohort 1, Cohort 2B

HIV Clinical Trial 2023: Cabotegravir and Rilpivirine Highlights & Side Effects. Trial Name: NCT05660980 — Phase 1 & 2

Cabotegravir and Rilpivirine (Integrase Inhibitor and Non-Nucleoside Reverse Transcriptase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05660980 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the recruitment process for this trial open to individuals aged 45 or older?

"To be eligible for this clinical trial, participants must fall within the 2 to 11 age bracket. For those under 18 years old and above 65, there are 19 studies and 86 studies respectively."

Answered by AI

For what type of individuals is eligibility for this investigation applicable?

"Eligible candidates for this study must have HIV-1, be between 2 and 11 years old, and the total recruitment goal is 90 participants."

Answered by AI

Is this medical research currently recruiting participants?

"According to clinicaltrials.gov, this research investigation is not currently taking in volunteers. It was first listed on May 1st 2023 and last revised on December 13th 2022; however, there are presently an additional 109 trials recruiting participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05660980.