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Integrase Inhibitor

Study to Evaluate Pharmacokinetic (PK), Safety and Tolerability of Cabotegravir (CAB) 400 Milligrams Per Milliliter (mg/mL) Formulation in Healthy Adult Participants

Phase 1

Waitlist Available

Research Sponsored by ViiV Healthcare

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

All Individual Drugs Already Approved

Summary

This trial is testing a long-lasting medication called CAB given through injections. The study involves healthy adults to see if the treatment is safe and well-tolerated. The medication is designed to release slowly in the body, reducing the need for frequent doses. Cabotegravir (CAB) has been studied extensively for its use in long-acting injectable forms, particularly in the context of HIV treatment and prevention.

Eligible Conditions

Human Immunodeficiency Virus (HIV) Infection
HIV Suppression

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

15Treatment groups

Experimental Treatment

Active Control

Group I: Part 2: Cohort 6: CAB 400 mg/mL IM (gluteus medius)Experimental Treatment2 Interventions

Eligible participants will receive 1 tablet of CAB 30 mg once daily for 28 days during the oral lead-in phase, followed by a wash out period of 7 to 14 days. Participants will then receive two IM gluteal injections of CAB 400 mg/mL formulation administered 12 weeks apart. The determination of the dose and dosing schedule will be governed by the STR.

Group II: Part 2: Cohort 5: CAB 400 mg/mL IM (gluteus medius)Experimental Treatment2 Interventions

Eligible participants will receive 1 tablet of CAB 30 mg once daily for 28 days during the oral lead-in phase, followed by a wash out period of 7 to 14 days. On Day 1 of Part 1, participants will be administered a loading dose of 800 mg as 1 x 2 mL CAB 400 mg/mL via IM (gluteus medius) injection. Participants will receive a second injection of CAB 400 mg/mL formulation via IM (gluteal injection) 12 weeks apart. The determination of the dose of the second injection will be governed by the Study Team safety and PK Review (STR).

Group III: Part 1:Cohort 3: CAB 400 mg/mL IM (lateral thigh)Experimental Treatment2 Interventions

Eligible participants will receive 1 tablet of CAB 30 mg once daily for 28 days during the oral lead-in phase, followed by a wash out period of 7 to 14 days. On Day 1 of Part 1, participants will be administered a loading dose of CAB 600 mg given as 1 x 1.5 mL or 400 mg given as 1 x 1 mL CAB 400 mg/mL formulation via IM (lateral thigh) injection. Participants will receive a second injection of CAB 400 mg given as 1 x 1 mL CAB 400 mg/mL via IM (lateral thigh) at Week 4.

Group IV: Part 1:Cohort 2: CAB 400 mg/mL SC abdominalExperimental Treatment2 Interventions

Eligible participants will receive 1 tablet of CAB 30 mg once daily for 28 days during the oral lead-in phase, followed by a wash out period of 7 to 14 days. On Day 1 of Part 1, participants will be administered a loading dose of CAB 600 mg given as 1 x 1.5 mL CAB 400 mg/mL formulation via SC abdominal injection. Participants will receive a second injection of CAB 200 mg given as 1 x 0.5 mL CAB 400 mg/mL via SC abdominal at Week 4.

Group V: Part 1:Cohort 1: CAB 400 mg/mL IM glutealExperimental Treatment2 Interventions

Eligible participants will receive 1 tablet of CAB 30 mg once daily for 28 days during the oral lead-in phase, followed by a wash out period of 7 to 14 days. On Day 1 of Part 1, participants will be administered a loading dose of CAB 600 mg given as 1 x 1.5 mL CAB 400 mg/mL formulation via IM gluteal injection. Participants will receive a second injection of CAB 400 mg given as 1 x 1 mL CAB 400 mg/mL via IM gluteal injection at Week 4.

Group VI: Part 1: Cohort 4h: CAB 400 mg/mL (SC)Experimental Treatment3 Interventions

Group VII: Part 1: Cohort 4b: CAB 400 mg/mL (SC)Experimental Treatment5 Interventions

Group VIII: Part 1: Cohort 4: CAB 400 mg/mL (IM or SC)Experimental Treatment2 Interventions

Eligible participants will receive 1 tablet of CAB 30 mg once daily for 28 days during the oral lead-in phase, followed by a wash out period of 7 to 14 days. On Day 1 of Part 1, participants will be administered a loading dose of 400 mg as 1 x 1 mL CAB 400 mg/mL via IM (gluteal injection). Participants will receive a second injection of 200 mg as 1 x 0.5 mL CAB 400 mg/mL via SC (abdominal) at Week 4.

Group IX: Part 1: Cohort 4h: CAB 200 mg/mL (SC)Active Control3 Interventions

Group X: Part 2: Cohort 6: CAB 200 mg/mL IM (gluteus medius)Active Control2 Interventions

Eligible participants will receive 1 tablet of CAB 30 mg once daily for 28 days during the oral lead-in phase, followed by a wash out period of 7 to 14 days. Participants will then receive two IM gluteal injections of CAB 200 mg/mL formulation administered 12 weeks apart. The determination of the dose and dosing schedule will be governed by the STR.

Group XI: Part 1:Cohort 1: CAB 200 mg/mL IM glutealActive Control2 Interventions

Eligible participants will receive 1 tablet of CAB 30 mg once daily for 28 days during the oral lead-in phase, followed by a wash out period of 7 to 14 days. On Day 1 of Part 1, participants will be administered a loading dose of CAB 600 mg given as 1 x 3 mL CAB 200 mg/mL via IM gluteal injection. Participants will receive a second injection of CAB 400 mg given as 1 x 2 mL CAB 200 mg/mL via IM gluteal injection at Week 4.

Group XII: Part 1:Cohort 2: CAB 200 mg/mL SC abdominalActive Control2 Interventions

Eligible participants will receive 1 tablet of CAB 30 mg once daily for 28 days during the oral lead-in phase, followed by a wash out period of 7 to 14 days. On Day 1 of Part 1, participants will be administered a loading dose of CAB 300 mg as 1x 1.5 mL CAB 200 mg/mL via SC abdominal injection. Participants will receive a second injection of CAB 100 mg as 1 x 0.5 mL CAB 200 mg/mL SC abdominal at Week 4.

Group XIII: Part 1:Cohort 3: CAB 200 mg/mL IM (lateral thigh)Active Control2 Interventions

Eligible participants will receive 1 tablet of CAB 30 mg once daily for 28 days during the oral lead-in phase, followed by a wash out period of 7 to 14 days. On Day 1 of Part 1, participants will be administered a loading dose of 600 mg given as 1 x 3 mL or 400 mg as 1 x 2 mL CAB 200 mg/mL via IM (lateral thigh) injection. Participants will receive a second injection of 400 mg as 1 x 2 mL CAB 200 mg/mL via IM (lateral thigh) at Week 4.

Group XIV: Part 1: Cohort 4: CAB 200 mg/mL (IM or SC)Active Control2 Interventions

Eligible participants will receive 1 tablet of CAB 30 mg once daily for 28 days during the oral lead-in phase, followed by a wash out period of 7 to 14 days. On Day 1 of Part 1, participants will be administered a loading dose of 400 mg as 1 x 2 mL CAB 200 mg/mL via IM (gluteal injection). Participants will receive a second injection of 100 mg as 1 x 0.5 mL CAB 200 mg/mL via SC (abdominal) at Week 4.

Group XV: Part 2: Cohort 5: CAB 200 mg/mL IM (gluteus medius)Active Control2 Interventions

Eligible participants will receive 1 tablet of CAB 30 mg once daily for 28 days during the oral lead-in phase, followed by a wash out period of 7 to 14 days. On Day 1 of Part 1, participants will be administered a loading dose of 400 mg as 1 x 2 mL CAB 200 mg/mL via IM (gluteus medius) injection. Participants will receive a second injection of CAB 200 mg/mL formulation via IM (gluteal injection) 12 weeks apart. The determination of the dose of the second injection will be governed by the STR.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Topical steroid

2020

Completed Phase 1

~140

Hyaluronidase (human recombinant)

FDA approved

Topical non-steroidal anti-inflammatory drug

2020