What side effects are associated with this type of intervention?

Common treatments for HIV, such as Cabotegravir and Rilpivirine, are generally well-tolerated but can have side effects. For Cabotegravir, side effects may include injection site reactions, fever, fatigue, and headache. Rilpivirine can cause side effects such as depression, insomnia, headache, and rash. Both medications are associated with a favorable safety profile, but patients should be monitored for these potential adverse effects.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of HIV that are similar to Cabotegravir and Rilpivirine. For Integrase Strand Transfer Inhibitors (INSTIs), notable approvals include Dolutegravir, Raltegravir, and Elvitegravir. These drugs work by inhibiting the integrase enzyme, preventing the integration of viral DNA into the host genome. For Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs), approved drugs include Efavirenz, Nevirapine, and Etravirine, which inhibit the reverse transcriptase enzyme, blocking the conversion of viral RNA into DNA. These classes of drugs are often used in combination therapies to effectively manage HIV infection.

What other types of research exist?

Promising novel alternatives to Cabotegravir and Rilpiverine for HIV treatment include Lenacapavir, a capsid inhibitor, and Islatravir, a nucleoside reverse transcriptase translocation inhibitor. Both have shown potential in clinical trials for their efficacy, safety, and long-acting formulations, which could improve adherence and outcomes for patients.

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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)

Must not have

Adolescent participant has experienced adverse events related to study product or discontinued study product due to adverse events

Adolescent participant has certain medical conditions such as heart failure, active tuberculosis, hepatitis B or C infection, hepatic disease, need for chronic anti-coagulation, bleeding disorders, or known allergy to study product components

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

No Placebo-Only Group

Summary

This trial tests new HIV medications in pill and injection forms for children and teens. The medications work by stopping the virus from growing.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am a teenager who had side effects from the study product or stopped using it because of side effects.

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I am an adolescent with conditions like heart failure, TB, hepatitis, liver disease, bleeding disorders, or allergies to study drugs.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 2: samples collected pre-dose and 1, 2, 3, 4, 8 and (for q4w dosing) 24 hours post-dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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)

+17 more

Secondary study objectives

Geometric Mean Pre-dose Concentration (C0) of Oral CAB (Cohort 2)

Geometric Mean Ratio of Pre-dose CAB and RPV Concentrations at Week 24: Pre-dose CAB and RPV Concentrations at Week 16 (Cohort 2)

Geometric Mean Ratio of Pre-dose CAB and RPV Concentrations at Week 24: Pre-dose CAB and RPV Concentrations at Week 8 (Cohort 2)

+12 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 or final safety extension visit.

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 or final safety extension visit.

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

Oral Cabotegravir (CAB)

2019

Completed Phase 2

~80

Long-Acting Injectable Cabotegravir (CAB LA)

2019

Completed Phase 2

~80

Combination Antiretroviral Therapy (cART)

2015

Completed Phase 2

~130

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Integrase Strand Transfer Inhibitors (InSTIs) like Cabotegravir inhibit the integrase enzyme, preventing the integration of viral DNA into the host cell genome, which is crucial for viral replication. Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) such as Rilpivirine inhibit the reverse transcriptase enzyme, blocking the conversion of viral RNA into DNA. These treatments are essential for HIV patients as they target different stages of the viral life cycle, reducing viral load, enhancing immune function, and preventing the progression to AIDS.

Advances in antiretroviral therapy.