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Integrase Inhibitor

Injectable Cabotegravir for HIV Prevention

Phase 2 & 3

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

MSM and TGW, 18 years or older at the time of screening (male at birth)

Be older than 18 years old

Must not have

Current or chronic history of liver disease or known hepatic or biliary abnormalities

Inflammatory skin conditions that compromise the safety of intramuscular injections

Timeline

Screening 3 weeks

Treatment Varies

Follow Up reported week 57 (injection visit #8) and week 105 (injection visit #14)

Summary

This trial will test whether the injectable drug cabotegravir is safe and effective for preventing HIV in cisgender men who have sex with men and transgender women who have sex with men.

Who is the study for?

This trial is for HIV-uninfected cisgender men and transgender women who have sex with men, are at high risk of acquiring HIV, and in general good health. Participants must be willing to consent, have a negative HIV test, no significant liver disease or cardiovascular issues, not use illicit intravenous drugs recently or be on certain medications that could interfere with the study.

What is being tested?

The trial is testing cabotegravir (CAB LA), an injectable drug for pre-exposure prophylaxis (PrEP) against HIV. It compares CAB LA's safety and effectiveness to TDF/FTC tablets (current PrEP standard). Some participants will receive placebos instead of active drugs as part of the study design.

What are the potential side effects?

Possible side effects include reactions at the injection site such as pain or swelling, potential allergic responses to components like egg or soy found in Intralipid used in injections, and other common medication-related adverse events which will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a man who has sex with men or a transgender woman, 18 or older, and was male at birth.

Exclusion Criteria

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

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I have a history of liver disease or liver abnormalities.

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I have skin conditions that make injections unsafe.

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I do not have a bleeding disorder that prevents me from receiving injections in the muscle.

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I am not taking any medications that are not allowed in the study.

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I have a history of seizures.

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I have had surgery or injections for buttock enhancements.

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I have a serious heart condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ reported week 57 (injection visit #8) and week 105 (injection visit #14)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~reported week 57 (injection visit #8) and week 105 (injection visit #14)

This trial's timeline: 3 weeks for screening, Varies for treatment, and reported week 57 (injection visit #8) and week 105 (injection visit #14) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of Participants Experiencing Grade 2 or Higher Clinical and Laboratory Adverse Events

Number of Participants With Documented Incident HIV Infections During Steps 1 and 2

Secondary study objectives

Changes From Baseline in Creatinine and Creatinine Clearance Levels

Changes in Blood Pressure From Baseline

Changes in Fasting Glucose Levels From Baseline

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm BExperimental Treatment3 Interventions

In Step 1, participants will receive daily oral TDF/FTC and daily oral CAB placebo for 5 weeks. In Step 2, participants will receive daily oral TDF/FTC and placebo for CAB LA to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks.

Group II: Arm AExperimental Treatment4 Interventions

In Step 1, participants will receive daily oral CAB and daily oral TDF/FTC placebo for 5 weeks. In Step 2, participants will receive CAB LA and daily oral TDF/FTC placebo to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CAB LA

2014

Completed Phase 3

~1090

0 / 8Eligibility criteria met