Cabotegravir + Rilpivirine for HIV Infection
(MOCHA Trial)

Recruiting in Palo Alto (17 mi)

+25 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial tests new HIV medications in pill and injection forms for children and teens. The medications work by stopping the virus from growing.

Eligibility Criteria

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.

Inclusion Criteria

I have been on the same HIV treatment for at least 3 months.

Participants enrolling into Cohort 1 must have completed all scheduled product injections and Week 16 visit in Cohort 1 Step 2

My BMI is 31.5 or lower.

+9 more

Exclusion Criteria

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.

Parents or caregivers will be excluded if they have any condition or social circumstance that may make study participation unsafe or interfere with achieving study objectives

+4 more

Participant Groups

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.

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).