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Integrase Inhibitor

Cabotegravir + Rilpivirine for HIV Infection (MOCHA Trial)

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
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 measured through week 48
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 below
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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 weeks
Treatment ~ Varies
Follow Up ~measured through week 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured through week 48 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants who died due to adverse events assessed as related to study product/s (Cohort 1)
Number of participants who had Grade 3 or higher adverse events (Cohort 1)
Number of participants who had Grade 3 or higher adverse events assessed as related to study product/s (Cohort 1)
+2 more
Secondary outcome measures
Frequency of all adverse events, regardless of severity grade (Cohort 2)
Number of participants who are virologic failures (Cohort 2)
Number of participants who died due to adverse events assessed as related to study product/s (Cohort 2)
+8 more

MOCHA Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort 2: CAB + RPVExperimental 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 injection: CAB LA administered as one 600 mg (3 mL) IM injection AND RPV LA administered as one 900 mg (3 mL) IM injection, at Week 4b (Step 4 Entry) and at Week 8. Subsequent injections: starting at Week 16, CAB LA administered as a 600 mg (3 mL) IM injection AND RPV LA administered as a 900 mg (3 mL) IM injection, every eight weeks through Week 96.
Group II: 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: RPV LA administered as one IM injection at Week 4b (Step 2 Entry) study visit (900 mg/3 mL), and at Week 8 (900 mg/3 mL).
Group III: 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: CAB LA administered as one IM injection at Week 4b (Step 2 Entry) study visit (600 mg/3 mL), and at Week 8 (600 mg/3 mL).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Combination Antiretroviral Therapy (cART)
2015
Completed Phase 2
~130

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,269 Previous Clinical Trials
5,481,314 Total Patients Enrolled
ViiV HealthcareIndustry Sponsor
360 Previous Clinical Trials
468,424 Total Patients Enrolled
Aditya H. Gaur, MDStudy ChairSt. Jude Children's Research Hospital
1 Previous Clinical Trials
44 Total Patients Enrolled

Media Library

Long-Acting Injectable Cabotegravir (Integrase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03497676 — Phase 1 & 2
Human Immunodeficiency Virus Infection Research Study Groups: Cohort 1C: CAB, Cohort 1R: RPV, Cohort 2: CAB + RPV
Long-Acting Injectable Cabotegravir (Integrase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03497676 — Phase 1 & 2

Frequently Asked Questions

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

Are there any restrictions for who is able to participate in this research project?

"This clinical trial is looking for 155 participants between the ages of 12 and 17 who have HIV infections. In addition to this, participants must also meet the following criteria: they must be enrolled in Cohort 1 Step 1 or Cohort 2 Step 3, have a body weight of at least 35 kg (77 lbs), and have a body mass index (BMI) of less than or equal to 31.5 kg/m^2. Furthermore, participants must be willing and able to comply with the study visit schedule and other study requirements, as well as have confirmed HIV-1-infection based on documented testing of two samples"

Answered by AI

Are there still openings in this clinical trial for new participants?

"Yes, this study is still open to recruitment, as reflected on clinicaltrials.gov. The trial was originally posted on March 19th, 2019 and has since been updated on September 29th, 2020."

Answered by AI

Does this research project include individuals above the age of 30?

"The age range for potential participants in this clinical trial is 12 to 17 years old."

Answered by AI

Is there precedent for using CAB as an oral medication?

"The oral drug cabotegravir was first studied in 2002 at the University of Zurich. To date, there have been 71 completed clinical trials on the drug. There are presently 21 actively recruiting trials, with many of these studies taking place in Los Angeles, California."

Answered by AI

What is the standard recommended use for Cabotegravir?

"Oral Cabotegravir (CAB) is a common treatment for hiv test negative patients. Additionally, it can be used to manage treatment failure, viral resistance, and hiv-1 rna less than or equal to 100,000 copies/ml."

Answered by AI

Why was this particular clinical trial developed?

"The primary outcome of this clinical trial will be the number of participants who experience grade 3 or higher adverse events, as measured over a 16-week period. Secondary outcomes include the frequency of all adverse events regardless of severity grade, the number of participants who have grade 3 or higher adverse events assessed as related to study product/s, and the number of participants with HIV-1 RNA < 50 copies/mL."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
What site did they apply to?
Usc La Nichd Crs
Rush Univ. Cook County Hosp. Chicago NICHD CRS
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
More Options for Children and Adolescents (MOCHA): Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in HIV-Infected Children and Adolescents
2019. "More Options for Children and Adolescents (MOCHA): Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in HIV-Infected Children and Adolescents". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03497676.
All > Hiv Infection
~25 spots leftby Apr 2025
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