CompletedPhase 1/2

More Options for Children and Adolescents (MOCHA): Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in HIV-Infected Children and Adolescents

United States168 participantsStarted 2019-04-03

Plain-language summary

The purpose of this study was to determine the dosage for oral cabotegravir (CAB) and long-acting cabotegravir (CAB LA) and long-acting rilpiverine (RPV LA) and evaluate the safety, acceptability, tolerability, and pharmacokinetics (PK) of oral CAB, CAB LA, and RPV LA in virologically suppressed children and adolescents living with HIV.

Who can participate

Age range12 Years – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Cohort 1 Step 1, Cohort 2 Step 3, and Cohort 2 Step 5 All the following criteria must be met for inclusion of any adolescent participant in Step 1 of Cohort 1, or in Step 3 of Cohort 2, unless otherwise noted: * At enrollment, body weight greater than or equal to 35 kg (77 lbs) * Note: For Cohort 1 Step 2 participants, body weight will not be exclusionary for enrollment into Cohort 2 Step 3, if otherwise eligible. * For Cohort 1, at enrollment, body mass index (BMI) less than or equal to 31.5 kg/m\^2 * At enrollment, willing and able to comply with the study visit schedule and other study requirements, as determined by the site investigator or designee * Confirmed HIV-1-infection based on documented testing of two samples collected at different time points. More information on this criterion can be found in the protocol. * For at least 3 consecutive months (defined as 90 consecutive days) prior to screening, and prior to enrollment, has been on stable unchanged cART consisting of 2 or more drugs from 2 or more classes of antiretroviral drugs, ascertainment of this criterion may be based on parent or guardian report only, but available medical records should also be reviewed in relation to this criterion. * Note: Participants undergoing dose modifications to their antiretroviral regimen for growth or who are switching medication formulation(s) are considered to be on a stable cART. * Has at least one documented plasma HIV-1 RNA less than the lower l…

What they're measuring

Proportion of Participants Who Had Grade 3 or Higher Adverse Event (Cohort 1)

Timeframe: Cohort 1 Treatment Initiation through Week 4

Proportion of Participants Who Had Grade 3 or Higher Adverse Events Assessed as Related to Study Product/s (Cohort 1)

Timeframe: Cohort 1 Treatment Initiation through Week 4

Proportion of Participants Who Had Serious Adverse Events Meeting International Conference on Harmonisation (ICH) Criteria Assessed as Related to Study Product/s (Cohort 1)

Timeframe: Cohort 1 Treatment Initiation through Week 4

Proportion of Participants Who Permanently Discontinued Study Product Due to Adverse Events Assessed as Related to Study Product/s (Cohort 1)

Timeframe: Cohort 1 Treatment Initiation through Week 4

Proportion of Participants Who Died Due to Adverse Events Assessed as Related to Study Product/s (Cohort 1)

Timeframe: Cohort 1 Treatment Initiation through Week 4

Proportion of Participants Who Had Grade 3 or Higher Adverse Events (Cohort 1)

Timeframe: Cohort 1 Treatment Initiation through Week 16

Proportion of Participants Who Had Grade 3 or Higher Adverse Events Assessed as Related to Study Product/s (Cohort 1)

Trial details

NCT IDNCT03497676

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2023-02-18

Results submitted2024-02-12

View on ClinicalTrials.gov More HIV Infections trials

Plain-language summary

Who can participate

Age range12 Years – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Proportion of Participants Who Had Grade 3 or Higher Adverse Event (Cohort 1)

Timeframe: Cohort 1 Treatment Initiation through Week 4

Proportion of Participants Who Had Grade 3 or Higher Adverse Events Assessed as Related to Study Product/s (Cohort 1)

Timeframe: Cohort 1 Treatment Initiation through Week 4

Proportion of Participants Who Had Serious Adverse Events Meeting International Conference on Harmonisation (ICH) Criteria Assessed as Related to Study Product/s (Cohort 1)

Timeframe: Cohort 1 Treatment Initiation through Week 4

Proportion of Participants Who Permanently Discontinued Study Product Due to Adverse Events Assessed as Related to Study Product/s (Cohort 1)

Timeframe: Cohort 1 Treatment Initiation through Week 4

Proportion of Participants Who Died Due to Adverse Events Assessed as Related to Study Product/s (Cohort 1)

Timeframe: Cohort 1 Treatment Initiation through Week 4

Proportion of Participants Who Had Grade 3 or Higher Adverse Events (Cohort 1)

Timeframe: Cohort 1 Treatment Initiation through Week 16

Proportion of Participants Who Had Grade 3 or Higher Adverse Events Assessed as Related to Study Product/s (Cohort 1)