CompletedPhase 1

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

United States, New Zealand138 participantsStarted 2020-07-31

Plain-language summary

This is an active control, randomized study to investigate the safety, tolerability and PK of repeat dose administration of long-acting CAB 400 mg/mL formulation intramuscular (IM) (gluteus medius and vastus lateralis) and subcutaneous (SC) (abdominal) injections in healthy adult participants.

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Heart rate: For Males \<45 or \>100 beats per minute (bpm), for females \<50 or \>100 bpm.
. PR Interval: For males and females \<120 or \>220 msec.
. QRS duration: For males and females \<70 or \>120 msec.
. QT duration corrected for heart rate by Fridericia's formula (QTcF) interval: For males and females \>450 msec.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Part 1 Injection 1: Time of Maximum Observed Plasma Concentration (Tmax) for CAB 400 mg/ml Formulation for Cohorts 1,2,3,4, 4b & 4h

Timeframe: Injection 1 - Day 1 to Week 4

Part 1 Injection 2: Tmax for CAB 400 mg/ml Formulation for Cohorts 1,2,3,4 & 4b

Timeframe: Injection 2 - Day 1 to Week 52 follow-up

Part 2 Injection 1: Tmax for CAB 400 mg/ml Formulation for Cohort 5

Timeframe: Injection 1 - Day 1 to Week 12

Part 2 Injection 2: Tmax for CAB 400 mg/ml Formulation for Cohort 5

Timeframe: Injection 2 - Day 1 to Week 52 follow-up

Part 1 Injection 2: Apparent Terminal Phase Half-life (T1/2) for CAB 400 mg/ml Formulation for Cohorts 1,2,3,4 & 4b

Timeframe: Injection 2 - Week 4 to Week 52 follow-up

Part 2 Injection 2: T1/2 for CAB 400 mg/ml Formulation for Cohort 5

Timeframe: Injection 2 - Week 12 to Week 52 follow-up

Trial details

NCT IDNCT04484337

SponsorViiV Healthcare

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-05-05

Results submitted2024-05-03

View on ClinicalTrials.gov More HIV Infections trials

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Heart rate: For Males \<45 or \>100 beats per minute (bpm), for females \<50 or \>100 bpm.
. PR Interval: For males and females \<120 or \>220 msec.
. QRS duration: For males and females \<70 or \>120 msec.
. QT duration corrected for heart rate by Fridericia's formula (QTcF) interval: For males and females \>450 msec.

What they're measuring

Part 1 Injection 1: Time of Maximum Observed Plasma Concentration (Tmax) for CAB 400 mg/ml Formulation for Cohorts 1,2,3,4, 4b & 4h

Timeframe: Injection 1 - Day 1 to Week 4

Part 1 Injection 2: Tmax for CAB 400 mg/ml Formulation for Cohorts 1,2,3,4 & 4b

Timeframe: Injection 2 - Day 1 to Week 52 follow-up

Part 2 Injection 1: Tmax for CAB 400 mg/ml Formulation for Cohort 5

Timeframe: Injection 1 - Day 1 to Week 12

Part 2 Injection 2: Tmax for CAB 400 mg/ml Formulation for Cohort 5

Timeframe: Injection 2 - Day 1 to Week 52 follow-up

Part 1 Injection 2: Apparent Terminal Phase Half-life (T1/2) for CAB 400 mg/ml Formulation for Cohorts 1,2,3,4 & 4b

Timeframe: Injection 2 - Week 4 to Week 52 follow-up

Part 2 Injection 2: T1/2 for CAB 400 mg/ml Formulation for Cohort 5

Timeframe: Injection 2 - Week 12 to Week 52 follow-up