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 States, Botswana, South Africa168 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 range

12 Years – 17 Years

Sex

ALL

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

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 range

12 Years – 17 Years

Sex

ALL

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