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Cabotegravir Sodium

This article explores the ongoing clinical trials of Cabotegravir Sodium, a potential long-acting treatment for HIV infections. The study aims to assess the safety, tolerability, and effectiveness of different formulations and administration methods of Cabotegravir, providing valuable insights into its potential as a new option for HIV management.

Table of Contents

What is Cabotegravir?

Cabotegravir sodium, also known as CAB, is a medication being studied for the treatment of HIV infections[1]. HIV, or Human Immunodeficiency Virus, is a virus that attacks the body’s immune system, making it difficult to fight off infections and diseases. Cabotegravir belongs to a class of drugs called integrase inhibitors, which work by preventing the HIV virus from multiplying in the body.

How is Cabotegravir Administered?

Cabotegravir can be administered in several ways[1]:

  • Oral tablets: 30 mg tablets for oral administration, typically used as a lead-in treatment.
  • Intramuscular (IM) injection: Injected into the muscle, usually in the buttocks (gluteus medius) or thigh (vastus lateralis).
  • Subcutaneous (SC) injection: Injected under the skin, typically in the abdominal area.

The study is testing two different concentrations of cabotegravir for injections[1]:

  • Cabotegravir 400 mg/mL: A higher concentration formulation
  • Cabotegravir 200 mg/mL: A lower concentration formulation used as an active comparator

Clinical Trial Overview

The clinical trial (NCT04484337) is designed to evaluate the pharmacokinetics, safety, and tolerability of cabotegravir[1]. Pharmacokinetics refers to how the drug moves through the body, including how it’s absorbed, distributed, metabolized, and excreted. This information helps researchers understand how the medication behaves in the body and determine the most effective dosing regimen.

Study Design

The study is divided into two parts[1]:

  • Part 1: Participants receive repeat doses of cabotegravir at four-week (Q4W) intervals.
  • Part 2: Participants receive repeat doses of cabotegravir at twelve-week (Q12W) intervals.

The study is designed as a double-blind trial, meaning that neither the participants nor the immediate study team knows which specific treatment each participant is receiving. This helps to prevent bias in the study results[1].

Outcomes Measured

The study measures several key aspects of how cabotegravir behaves in the body[1]:

  • Maximum concentration (Cmax): The highest level of the drug in the blood after administration.
  • Time to maximum concentration (Tmax): How long it takes to reach the highest drug level in the blood.
  • Area under the curve (AUC): A measure of the total exposure to the drug over time.
  • Trough concentration (Ctau): The lowest level of the drug in the blood just before the next dose.
  • Half-life (T1/2): The time it takes for half of the drug to be eliminated from the body.
  • Absorption rate (KALA): How quickly the drug is absorbed into the bloodstream.

These measurements help researchers understand how long the drug stays in the body and how often it needs to be administered to maintain effective levels.

Safety Considerations

The study also focuses on the safety of cabotegravir by monitoring[1]:

  • Adverse events (AEs): Any unfavorable and unintended sign, symptom, or disease that occurs during the study, whether or not it’s related to the treatment.
  • Liver biochemistry abnormalities: Changes in liver function tests that might indicate potential liver issues.

These safety measures are crucial in determining whether the medication is well-tolerated and safe for long-term use in patients with HIV infections.

Aspect Details
Study Type Phase 1, double-blind, active-control, randomized study
Drug Studied Cabotegravir Sodium (CAB)
Formulations Oral tablets (30 mg), Injectable solutions (200 mg/mL and 400 mg/mL)
Administration Methods Oral, Intramuscular (IM) injection, Subcutaneous (SC) injection
Injection Sites Gluteus medius (buttocks), Vastus lateralis (thigh), Abdominal area
Dosing Schedules Every 4 weeks (Q4W) in Part 1, Every 12 weeks (Q12W) in Part 2
Primary Outcomes Pharmacokinetic parameters (Cmax, Tmax, AUC, Ctau, T1/2, KALA)
Secondary Outcomes Safety assessments, Adverse events, Liver function tests
Study Duration Up to 52 weeks follow-up

FAQ

  • What is Cabotegravir Sodium? Cabotegravir Sodium is a drug being studied as a potential long-acting treatment for HIV infections. It is available in both oral tablet form and as injectable formulations for intramuscular or subcutaneous administration.
  • What are the main goals of this clinical trial? The main goals of this trial are to evaluate the safety, tolerability, and pharmacokinetics (how the drug moves through the body) of different formulations and administration methods of Cabotegravir in healthy adult participants.
  • How is Cabotegravir administered in this study? Cabotegravir is administered in various ways throughout the study, including oral tablets, intramuscular injections (in the buttocks or thigh), and subcutaneous injections (under the skin of the abdomen).
  • How long does the study last? The study includes multiple parts with different dosing schedules. Some participants receive injections every 4 weeks, while others receive them every 12 weeks. The total follow-up period for participants is up to 52 weeks.
  • What are the potential benefits of a long-acting HIV treatment like Cabotegravir? Long-acting treatments like Cabotegravir could potentially improve treatment adherence and quality of life for people living with HIV by reducing the frequency of medication administration compared to daily oral treatments.

Ongoing Clinical Trials on Cabotegravir Sodium

  • Study on Long-Acting Cabotegravir and Lenacapavir for HIV Patients: Evaluating Dual Antiretroviral Therapy

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study of Injectable Cabotegravir Compared to Oral Emtricitabine/Tenofovir for HIV Prevention in Men Who Have Sex with Men

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study on Long-Acting Cabotegravir and Rilpivirine for HIV Patients in Spain: Evaluating Out-of-Hospital Treatment Options

    Not recruiting

    3 1 1 1
    Investigated drugs:
    Spain

Glossary

  • Pharmacokinetics (PK): The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Intramuscular (IM) injection: An injection method where medication is delivered directly into a muscle, such as the buttocks or thigh.
  • Subcutaneous (SC) injection: An injection method where medication is administered into the layer of tissue just beneath the skin.
  • Double-blind study: A research design where neither the participants nor the researchers directly involved know who is receiving which treatment, to prevent bias.
  • Active comparator: A group in a clinical trial that receives an established effective treatment to compare with the new treatment being studied.
  • Maximum observed plasma concentration (Cmax): The highest concentration of a drug observed in the blood plasma after administration.
  • Time of maximum observed plasma concentration (Tmax): The time it takes for a drug to reach its highest concentration in the blood plasma after administration.
  • Area under the concentration-time curve (AUC): A measure of the total exposure to a drug over time, used to assess the overall effectiveness of a medication.
  • Trough concentration (Ctau): The lowest concentration of a drug in the blood plasma just before the next dose is administered.
  • Terminal phase half-life (T1/2): The time it takes for the concentration of a drug in the body to decrease by half during the elimination phase.
  • Absorption rate constant (KALA): A measure of how quickly a drug is absorbed into the bloodstream from the site of administration.
  • Adverse events (AEs): Any unfavorable or unintended sign, symptom, or disease that occurs during a clinical trial, whether or not it is related to the treatment being studied.

References

  1. https://clinicaltrials.gov/study/NCT04484337