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Integrase Inhibitor
Cabotegravir + Rilpivirine for HIV Infection (MOCHA Trial)
Phase 1 & 2
Waitlist Available
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
Adolescent participant must have a body mass index (BMI) less than or equal to 31.5 kg/m^2
Adolescent participant must have a body weight greater than or equal to 35 kg (77 lbs)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 2: samples collected pre-dose and 1, 2, 3, 4, 8 and (for q4w dosing) 24 hours post-dose
Awards & highlights
MOCHA Trial Summary
This trial is testing two different doses of an experimental drug to see if it is safe and works well in children and teens with HIV who have the virus under control.
Who is the study for?
This trial is for HIV-infected children and adolescents aged 12 to less than 18 years, weighing at least 35 kg (77 lbs), with a BMI ≤31.5 kg/m^2, who have been on stable antiretroviral therapy for at least three months. Participants must have suppressed viral loads and be able to follow the study schedule. Those with certain medical conditions or taking disallowed medications cannot join.Check my eligibility
What is being tested?
The MOCHA trial is testing oral and injectable forms of Cabotegravir (CAB) and Rilpivirine (RPV) in young patients with controlled HIV infection. The goal is to find the right dosages, assess safety, acceptability, tolerability, and understand how these drugs work in the body over time.See study design
What are the potential side effects?
Possible side effects include reactions at injection sites, liver enzyme elevations which may indicate liver damage, pancreatitis symptoms due to increased lipase levels, kidney function changes measured by creatinine clearance rates; blood disorders like low platelet counts or anemia; heart rhythm abnormalities.
MOCHA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My BMI is 31.5 or lower.
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I weigh at least 77 lbs.
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My pregnancy test before joining the study was negative.
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I am between 12 and 17 years old.
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My lab tests are within normal or slightly abnormal ranges.
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My latest HIV test shows undetectable virus levels.
MOCHA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 2: samples collected pre-dose and 1, 2, 3, 4, 8 and (for q4w dosing) 24 hours post-dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 2: samples collected pre-dose and 1, 2, 3, 4, 8 and (for q4w dosing) 24 hours post-dose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Apparent Total Body Clearance (CL/F) of Step 1 Oral CAB (Cohort 1C)
Geometric Mean Area Under the Plasma Concentration-time Curve (AUC) for Step 1 Oral CAB (Cohort 1C)
Geometric Mean Concentration of LA CAB/LA RPV at Week 16 (Cohort 1 Q4W)
+21 moreSecondary outcome measures
Accumulation Ratio of Pre-dose CAB and RPV Concentrations at Week 24: Pre-dose CAB and RPV Concentrations at Week 16 (Cohort 2)
Accumulation Ratio of Pre-dose CAB and RPV Concentrations at Week 24: Pre-dose CAB and RPV Concentrations at Week 8 (Cohort 2)
Accumulation Ratio of Pre-dose CAB and RPV Concentrations at Week 48: Pre-dose CAB and RPV Concentrations at Week 16 (Cohort 2)
+12 moreMOCHA Trial Design
4Treatment groups
Experimental Treatment
Group I: Cohort 2B: CAB LA + RPV LAExperimental Treatment2 Interventions
Step 5: First and second injections: CAB LA administered as a 600 mg IM injection AND RPV LA administered as a 900 mg IM injection at Entry and at Week 4. Subsequent injections: starting at Week 12, CAB LA administered as a 600 mg IM injection AND RPV LA administered as 900 mg IM injection every eight weeks through Week 92.
Group II: Cohort 2A: oral CAB + oral RPV and CAB LA + RPV LAExperimental Treatment4 Interventions
Step 3: CAB administered orally as one 30 mg tablet once daily AND RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit for 4-6 weeks.
Step 4: First and second injections: CAB LA administered as a 600 mg IM injection AND RPV LA administered as a 900 mg IM injection at Week 4b and at Week 8. Subsequent injections: starting at Week 16, CAB LA administered as a 600 mg IM injection AND RPV LA administered as a 900 mg IM injection every eight weeks through Week 96.
Group III: Cohort 1R: RPVExperimental Treatment3 Interventions
Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12).
Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8).
Group IV: Cohort 1C: CABExperimental Treatment3 Interventions
Step 1: CAB administered orally as one 30 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.
Step 2 (Q4W dosing): CAB LA administered as three single intramuscular (IM) injections four weeks apart (600 mg injection at Week 4b, 400 mg injection at Week 8, and 400 mg injection at Week 12).
Step 2 (Q8W dosing): CAB LA administered as two single IM injections four weeks apart (600 mg injection at Week 4b and 600 mg injection at Week 8).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Combination Antiretroviral Therapy (cART)
2015
Completed Phase 2
~130
Oral Cabotegravir (CAB)
2019
Completed Phase 2
~80
Long-Acting Injectable Cabotegravir (CAB LA)
2019
Completed Phase 2
~80
Find a Location
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,277 Previous Clinical Trials
5,487,285 Total Patients Enrolled
ViiV HealthcareIndustry Sponsor
361 Previous Clinical Trials
468,479 Total Patients Enrolled
Aditya H. Gaur, MDStudy ChairSt. Jude Children's Research Hospital
1 Previous Clinical Trials
44 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been on the same HIV treatment for at least 3 months.I am a teenager on specific HIV treatments or have resistance to some HIV medications.I am a teenager who has had multiple seizures this year and may have other health issues that could affect the study.My BMI is 31.5 or lower.I weigh at least 77 lbs.I am a teenager eligible for a specific HIV treatment plan.My pregnancy test before joining the study was negative.I am using birth control and not planning to get pregnant soon.My caregiver is chosen by the study team, can consent, knows how I react to the study product, is in regular contact with me, and can do interviews in English.I am willing and able to follow the study's schedule and requirements.My lab tests are within normal or slightly abnormal ranges.My latest HIV test shows undetectable virus levels.I am between 12 and 17 years old.My HIV-1 RNA levels have been detectable in two tests within the last 6 months.I am a teenager who had side effects from the study product or stopped using it because of side effects.I am an adolescent with conditions like heart failure, TB, hepatitis, liver disease, bleeding disorders, or allergies to study drugs.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 2A: oral CAB + oral RPV and CAB LA + RPV LA
- Group 2: Cohort 2B: CAB LA + RPV LA
- Group 3: Cohort 1C: CAB
- Group 4: Cohort 1R: RPV
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.
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