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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See 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

Select...

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

2018

Completed Phase 3

~650

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

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

3,268 Previous Clinical Trials

5,476,562 Total Patients Enrolled

ViiV HealthcareIndustry Sponsor

359 Previous Clinical Trials

463,973 Total Patients Enrolled

Gilead SciencesIndustry Sponsor

1,082 Previous Clinical Trials

838,183 Total Patients Enrolled

Media Library

Cabotegravir (Integrase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02720094 — Phase 2 & 3

Human Immunodeficiency Virus Infection Research Study Groups: Arm A, Arm B

Human Immunodeficiency Virus Infection Clinical Trial 2023: Cabotegravir Highlights & Side Effects. Trial Name: NCT02720094 — Phase 2 & 3

Cabotegravir (Integrase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02720094 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Cabotegravir the only medication being used in this type of research?

"The first clinical trial for cabotegravir tablets occurred in 2014 at GSK Investigational Site. As of now, there are a total of 23 completed clinical trials. Out of these, 16 are active, with a large concentration in Memphis, Tennessee."

Answered by AI

Could you name a few of the hospitals that are testing this new treatment?

"Currently, this trial has 27 patients enrolled from research hospitals such as St. Jude Children's Research Hospital CRS in Memphis and Johns Hopkins University CRS in Baltimore. There are also 27 other locations where patients are participating."

Answered by AI

To the best of your knowledge, does this research project have any predecessors?

"16 clinical trials evaluating the efficacy of Cabotegravir tablets are currently underway in 155 cities across 30 nations. The first study, which began in 2014 and completed Phase 2 approval in 309 patients, was sponsored by Janssen Pharmaceuticals. Since then, 23 more trials have been completed."

Answered by AI

Are we enrolling new recruits for this experiment at the moment?

"Unfortunately, this particular trial is no longer enrolling patients, as reflected in the clinicaltrials.gov listing. Although this specific study is not recruiting, there are 511 other trials that are currently looking for participants."

Answered by AI

What is the main purpose that Cabotegravir tablets are designed for?

"Cabotegravir tablets are indicated for use in HIV negative patients as well as those who have failed other treatments, are virologically suppressed, or weigh at least 35 kg."

Answered by AI

Could you please explain how many individuals are included in this clinical trial?

"Currently, this study is not actively seeking participants. This specific trial was first posted on December 1st, 2016, with the most recent edit taking place on September 21st, 2022. There are 495 other clinical trials involving HIV-infected patients and 16 trials specifically for Cabotegravir tablets that are currently enrolling patients."

Answered by AI