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Integrase Inhibitor

Long-acting Cabotegravir Formulations in Healthy Adults

Q: What potential dangers are associated with administering Cabotegravir Formulation F to patients?

Due to its Phase 1 status, there is limited evidence available regarding the safety and efficacy of Part A: Participants receiving Cabotegravir Formulation F; it has thus been allocated a score of 1.

Q: Does my profile fulfill the requirements for this research endeavor?

Eligibility for this medical trial requires that the patient has <a href="https://www.withpower.com/clinical-trials/hiv">HIV</a>/<a href="https://www.withpower.com/clinical-trials/aids">AIDS</a> and is between 18-55 years old. Approximately 48 patients are needed to fill out the study's cohort.

Q: Is it possible to participate in this trial if one is younger than 55?

For a patient to be accepted into this medical trial, they must fall between ages 18 and 55. Meanwhile, there are 109 studies specifically for minors and 337 designed for older adults above 65 years of age.

Q: Is this research endeavor presently seeking participants?

According to the clinicaltrials.gov database, this medical study is no longer actively recruiting participants as it was last updated on September 4th 2023. However, there are still an abundance of other trials actively searching for patients at present with a total of 454 listings available.

Phase 1

Recruiting

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 8, 12 and 24

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 8, 12 and 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 8, 12 and 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 8, 12 and 24 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Absolute value of haematology parameter: Mean Corpuscle Volume (MCV) (Femtoliters)

Absolute value of haematology parameter: Mean Corpuscle haemoglobin (MCH) (Picograms)

Absolute value of haematology parameter: Platelet count (cells per microliter)

+25 more

Secondary outcome measures

Apparent long-acting absorption rate constant (KA-LA) of cabotegravir

Apparent terminal phase half-life (t1/2) of cabotegravir

Area under the concentration - time curve from time zero to infinity (AUC[0-inf]) of cabotegravir

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part B: Participants receiving Cabotegravir Formulation GExperimental Treatment1 Intervention

Group II: Part A: Participants receiving Cabotegravir Formulation FExperimental Treatment1 Intervention

0 / 2Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

ViiV HealthcareLead Sponsor

360 Previous Clinical Trials

468,531 Total Patients Enrolled

Frequently Asked Questions

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

What potential dangers are associated with administering Cabotegravir Formulation F to patients?

"Due to its Phase 1 status, there is limited evidence available regarding the safety and efficacy of Part A: Participants receiving Cabotegravir Formulation F; it has thus been allocated a score of 1."

Answered by AI

Does my profile fulfill the requirements for this research endeavor?

"Eligibility for this medical trial requires that the patient has HIV/AIDS and is between 18-55 years old. Approximately 48 patients are needed to fill out the study's cohort."

Answered by AI

Is it possible to participate in this trial if one is younger than 55?

"For a patient to be accepted into this medical trial, they must fall between ages 18 and 55. Meanwhile, there are 109 studies specifically for minors and 337 designed for older adults above 65 years of age."

Answered by AI

Is this research endeavor presently seeking participants?

"According to the clinicaltrials.gov database, this medical study is no longer actively recruiting participants as it was last updated on September 4th 2023. However, there are still an abundance of other trials actively searching for patients at present with a total of 454 listings available."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Two Different Formulations of Long-acting Cabotegravir in Healthy Adult Participants

2023. "A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Two Different Formulations of Long-acting Cabotegravir in Healthy Adult Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06033547.