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Integrase Inhibitor

Long-acting Cabotegravir Formulations in Healthy Adults

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

Is a WOCBP and using a contraceptive method that is highly effective, with a failure rate of <1% from the time of screening and inclusive of the entire time while on the study.

Body weight =>40 kilogram (kg) and body mass index (BMI) within the range =>18 to =<32 kilogram per meter square (kg/m^2)

Must not have

Evidence of previous myocardial infarction.

Hereditary coagulation and platelet disorders (e.g., haemophilia or Von Willebrand disease [VWD]).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (day 1) and up to week 52

Awards & highlights

No Placebo-Only Group

Summary

This trial will assess the safety and effectiveness of two different cabotegravir formulations in healthy adults. Data from the first formulation will determine if the second one is assessed.

Who is the study for?

Healthy adults over 40 kg and BMI of 18-32, not pregnant or breastfeeding, with no major health issues. Must test negative for COVID-19 on admission day, agree to use effective contraception, and have no history of drug abuse or high-risk behaviors for HIV infection.

What is being tested?

The trial is testing two different long-acting formulations of Cabotegravir (Formulation F followed by G) in healthy participants to assess their safety, tolerability, and how the body processes them.

What are the potential side effects?

Potential side effects are not detailed but monitoring for general safety and tolerability suggests possible reactions at injection sites, allergic responses or systemic effects as commonly seen with new medications.

Eligibility Criteria

Inclusion Criteria

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

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I am a woman of childbearing potential and use highly effective birth control.

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I weigh at least 40 kg and my BMI is between 18 and 32.

Exclusion Criteria

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

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I have had a heart attack before.

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I have a genetic blood clotting disorder like haemophilia or VWD.

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I have not been exposed to more than four new drugs in the last year.

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I have a history of liver disease or known liver problems.

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I haven't had significant seizures or needed treatment for them in the last 2 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (day 1) and up to week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (day 1) and up to week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1) and up to week 52 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Absolute values of Clinical Chemistry parameters: AST/SGOT, ALT/ SGPT, ALP and CPK (International Units per litre)

Change from baseline in Clinical Chemistry parameters: AST/SGOT, ALT/ SGPT, ALP and CPK (International Units per litre)

Secondary study objectives

Number of participants with worst case post-baseline values relative to potential clinical importance criteria compared to baseline for diastolic blood pressure (DBP), systolic blood pressure (SBP) and pulse rate