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Last Updated: February 8, 2025

CLINICAL TRIALS PROFILE FOR CABOTEGRAVIR


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All Clinical Trials for Cabotegravir

Trial ID Title Status Sponsor Phase Start Date Summary
NCT02120352 ↗ A Phase IIb Study to Evaluate a Long-Acting Intramuscular Regimen for Maintenance of Virologic Suppression (Following Induction With an Oral Regimen of GSK1265744 and Abacavir/Lamivudine) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected, Anti Active, not recruiting GlaxoSmithKline Phase 2 2014-04-28 This study is a Phase IIb, randomized, multicentre, parallel group, open-label, study having an overall objective to evaluate the antiviral activity, tolerability, and safety of two intramuscular (IM) dosing regimens of GSK744 LA plus TMC278 LA, relative to GSK744 30 milligram (mg) plus Abacavir/Lamivudine (ABC/3TC) given orally once daily (QD), in HIV-1 infected antiretroviral-naïve subjects. GSK744 is the oral formulation of GSK1265744 (cabotegravir), GSK744 LA is the long acting injectable formulation of GSK1265744 and TMC278 LA is the long acting injectable formulation of TMC278. The study will consist of three parts: an Induction Period, Maintenance Period and Extension Period. There is also a Long-Term Follow Up Period for subjects who withdraw from the study and have received at least one dose of GSK744 LA and / or TMC278 LA. In the Induction Period, eligible subjects will receive a combination of an oral regimen of 30 mg of GSK744 and 600/300 mg of ABC/3TC, once daily for 20 weeks. In the Maintenance Period, eligible subjects will be randomized 2:2:1 at Day 1 to receive an IM regimen of GSK744 LA 400 mg + TMC278 LA 600 mg every 4 weeks for 96 weeks (Q4W), an IM regimen of GSK744 LA 600 mg + TMC278 LA 900 mg every 8 weeks for 96 weeks (Q8W), or to continue on the oral Induction Period regimen of GSK744 30 mg + ABC/3TC once daily for 96 weeks (or 104 weeks if continuing on to the Extension Period). The Extension Period will allow for a collection of longer term efficacy and safety and tolerability data from subjects receiving GSK744 LA and TMC278 LA. The study will involve sufficient subjects at screening in order to ensure a total of approximately 265 subjects at the beginning of the Induction Period and approximately 225 subjects randomized into the Maintenance Period.
NCT02120352 ↗ A Phase IIb Study to Evaluate a Long-Acting Intramuscular Regimen for Maintenance of Virologic Suppression (Following Induction With an Oral Regimen of GSK1265744 and Abacavir/Lamivudine) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected, Anti Active, not recruiting Janssen Pharmaceuticals Phase 2 2014-04-28 This study is a Phase IIb, randomized, multicentre, parallel group, open-label, study having an overall objective to evaluate the antiviral activity, tolerability, and safety of two intramuscular (IM) dosing regimens of GSK744 LA plus TMC278 LA, relative to GSK744 30 milligram (mg) plus Abacavir/Lamivudine (ABC/3TC) given orally once daily (QD), in HIV-1 infected antiretroviral-naïve subjects. GSK744 is the oral formulation of GSK1265744 (cabotegravir), GSK744 LA is the long acting injectable formulation of GSK1265744 and TMC278 LA is the long acting injectable formulation of TMC278. The study will consist of three parts: an Induction Period, Maintenance Period and Extension Period. There is also a Long-Term Follow Up Period for subjects who withdraw from the study and have received at least one dose of GSK744 LA and / or TMC278 LA. In the Induction Period, eligible subjects will receive a combination of an oral regimen of 30 mg of GSK744 and 600/300 mg of ABC/3TC, once daily for 20 weeks. In the Maintenance Period, eligible subjects will be randomized 2:2:1 at Day 1 to receive an IM regimen of GSK744 LA 400 mg + TMC278 LA 600 mg every 4 weeks for 96 weeks (Q4W), an IM regimen of GSK744 LA 600 mg + TMC278 LA 900 mg every 8 weeks for 96 weeks (Q8W), or to continue on the oral Induction Period regimen of GSK744 30 mg + ABC/3TC once daily for 96 weeks (or 104 weeks if continuing on to the Extension Period). The Extension Period will allow for a collection of longer term efficacy and safety and tolerability data from subjects receiving GSK744 LA and TMC278 LA. The study will involve sufficient subjects at screening in order to ensure a total of approximately 265 subjects at the beginning of the Induction Period and approximately 225 subjects randomized into the Maintenance Period.
NCT02120352 ↗ A Phase IIb Study to Evaluate a Long-Acting Intramuscular Regimen for Maintenance of Virologic Suppression (Following Induction With an Oral Regimen of GSK1265744 and Abacavir/Lamivudine) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected, Anti Active, not recruiting ViiV Healthcare Phase 2 2014-04-28 This study is a Phase IIb, randomized, multicentre, parallel group, open-label, study having an overall objective to evaluate the antiviral activity, tolerability, and safety of two intramuscular (IM) dosing regimens of GSK744 LA plus TMC278 LA, relative to GSK744 30 milligram (mg) plus Abacavir/Lamivudine (ABC/3TC) given orally once daily (QD), in HIV-1 infected antiretroviral-naïve subjects. GSK744 is the oral formulation of GSK1265744 (cabotegravir), GSK744 LA is the long acting injectable formulation of GSK1265744 and TMC278 LA is the long acting injectable formulation of TMC278. The study will consist of three parts: an Induction Period, Maintenance Period and Extension Period. There is also a Long-Term Follow Up Period for subjects who withdraw from the study and have received at least one dose of GSK744 LA and / or TMC278 LA. In the Induction Period, eligible subjects will receive a combination of an oral regimen of 30 mg of GSK744 and 600/300 mg of ABC/3TC, once daily for 20 weeks. In the Maintenance Period, eligible subjects will be randomized 2:2:1 at Day 1 to receive an IM regimen of GSK744 LA 400 mg + TMC278 LA 600 mg every 4 weeks for 96 weeks (Q4W), an IM regimen of GSK744 LA 600 mg + TMC278 LA 900 mg every 8 weeks for 96 weeks (Q8W), or to continue on the oral Induction Period regimen of GSK744 30 mg + ABC/3TC once daily for 96 weeks (or 104 weeks if continuing on to the Extension Period). The Extension Period will allow for a collection of longer term efficacy and safety and tolerability data from subjects receiving GSK744 LA and TMC278 LA. The study will involve sufficient subjects at screening in order to ensure a total of approximately 265 subjects at the beginning of the Induction Period and approximately 225 subjects randomized into the Maintenance Period.
NCT02345707 ↗ Relative Bioavailability Study of Phase III Tablet Formulation of Cabotegravir Completed ViiV Healthcare Phase 1 2015-03-01 This study is a single-center, randomized, open-label, two cohorts, 3-way cross-over design in 36 subjects to assess the oral bioavailability of four new cabotegravir (CAB) sodium salt tablet formulations relative to the current CAB sodium salt formulation being used in the phase IIb studies under fasting conditions. All treatments will be administered as single 30 mg doses of CAB. Safety evaluations and serial PK samples will be collected during each treatment period. A follow-up visit will occur 10 - 14 days after the last dose of study drug. Treatment period doses will be separated by a 14 day washout. Participation in this study will be approximately 12 weeks.
NCT02411435 ↗ Effect of Rifampin (RIF) on the Pharmacokinetics (PK) of Oral Cabotegravir (CAB) in Healthy Subjects Completed GlaxoSmithKline Phase 1 2015-07-01 CAB is an integrase inhibitor that is currently in Phase 2 clinical trials for the treatment and prevention of human immunodeficiency virus-1 (HIV-1) infection. RIF, a rifamycin used for treatment of tuberculosis (common co-infection in HIV-infected subjects), is a known inducer of uridine diphosphate (UDP)-glucuronosyltransferases (UGTs) and Cytochrome P450 3A4 (CYP3A4). CAB is primarily metabolized via UGT1A1 and UGT1A9, thus a drug interaction between CAB and RIF is possible. This study will be a phase I, single-center, open label, fixed-sequence cross-over study to compare the single dose PK of CAB oral 30 milligrams (mg) when co-administered with RIF 600 mg once daily at steady-state to those of CAB oral 30 mg administered alone. Fifteen subjects are planned to be enrolled to obtain 12 evaluable subjects for this study.
NCT02411435 ↗ Effect of Rifampin (RIF) on the Pharmacokinetics (PK) of Oral Cabotegravir (CAB) in Healthy Subjects Completed ViiV Healthcare Phase 1 2015-07-01 CAB is an integrase inhibitor that is currently in Phase 2 clinical trials for the treatment and prevention of human immunodeficiency virus-1 (HIV-1) infection. RIF, a rifamycin used for treatment of tuberculosis (common co-infection in HIV-infected subjects), is a known inducer of uridine diphosphate (UDP)-glucuronosyltransferases (UGTs) and Cytochrome P450 3A4 (CYP3A4). CAB is primarily metabolized via UGT1A1 and UGT1A9, thus a drug interaction between CAB and RIF is possible. This study will be a phase I, single-center, open label, fixed-sequence cross-over study to compare the single dose PK of CAB oral 30 milligrams (mg) when co-administered with RIF 600 mg once daily at steady-state to those of CAB oral 30 mg administered alone. Fifteen subjects are planned to be enrolled to obtain 12 evaluable subjects for this study.
NCT02462772 ↗ Safety and Acceptability of Cabotegravir in HIV Uninfected Women in KwaZulu-Natal, South Africa Withdrawn ViiV Healthcare Phase 2 2015-10-01 The CAPRISA 014 trial aims to assess the safety and acceptability of the long-acting (LA) injectable antiretroviral agent, cabotegravir LA (GSK1265744), in HIV uninfected women in KwaZulu-Natal, South Africa.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Cabotegravir

Condition Name

Condition Name for Cabotegravir
Intervention Trials
HIV Infections 33
Infection, Human Immunodeficiency Virus 9
HIV-1-infection 6
HIV 3
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Condition MeSH

Condition MeSH for Cabotegravir
Intervention Trials
HIV Infections 38
Acquired Immunodeficiency Syndrome 16
Immunologic Deficiency Syndromes 12
Infections 8
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Clinical Trial Locations for Cabotegravir

Trials by Country

Trials by Country for Cabotegravir
Location Trials
United States 217
South Africa 32
Germany 28
Canada 26
Argentina 12
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Trials by US State

Trials by US State for Cabotegravir
Location Trials
Georgia 16
California 15
Texas 13
Florida 13
New York 11
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Clinical Trial Progress for Cabotegravir

Clinical Trial Phase

Clinical Trial Phase for Cabotegravir
Clinical Trial Phase Trials
Phase 4 8
Phase 3 17
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Cabotegravir
Clinical Trial Phase Trials
Not yet recruiting 16
Active, not recruiting 15
Recruiting 7
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Clinical Trial Sponsors for Cabotegravir

Sponsor Name

Sponsor Name for Cabotegravir
Sponsor Trials
ViiV Healthcare 34
National Institute of Allergy and Infectious Diseases (NIAID) 11
GlaxoSmithKline 8
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Sponsor Type

Sponsor Type for Cabotegravir
Sponsor Trials
Industry 56
Other 43
NIH 16
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Cabotegravir: A Revolutionary Advance in HIV Treatment and Prevention

Introduction to Cabotegravir

Cabotegravir, a potent integrase inhibitor, has been at the forefront of innovative HIV treatment and prevention strategies. Developed by ViiV Healthcare, this drug has shown promising results in various clinical trials and real-world studies, offering significant improvements over traditional daily oral therapies.

Clinical Trials Update

Phase I Trial: Cabotegravir Ultra Long-Acting (CAB-ULA)

A recent phase I clinical trial has introduced a new ultra long-acting formulation of cabotegravir, known as CAB-ULA. This formulation has demonstrated the potential to double the current dosing interval, allowing for injections at least every four months. The trial, involving 70 healthy adults, showed favorable pharmacokinetic, tolerability, and safety profiles, supporting the advancement of CAB-ULA to the next stage of clinical development[1].

LATITUDE Phase III Interim Trial Data

The LATITUDE phase III trial has provided interim data indicating that Cabenuva (cabotegravir + rilpivirine) is superior in maintaining viral load suppression compared to daily oral therapy, particularly in individuals with adherence challenges. The Data Safety Monitoring Board recommended transitioning participants from daily oral therapy to the long-acting injectable treatment due to its superior efficacy[4].

Real-World Studies for Apretude (Cabotegravir Long-Acting)

Real-world studies, such as those from the OPERA and Trio cohorts, have shown that Apretude (cabotegravir long-acting) is more than 99% effective in preventing HIV acquisition. These studies highlight the drug's high effectiveness and adherence rates, as well as improvements in quality of life by reducing stigma and anxiety associated with daily oral PrEP[2].

Pharmacokinetics and Safety

Pharmacokinetic Profiles

Studies have verified the pharmacokinetic models for cabotegravir, showing minimal differences in exposure across different age groups and genders. For instance, simulations indicated that the change in minimum concentration (Cmin) and area under the curve (AUC) for middle-aged and older adults were within a 0.8-1.25 fold range compared to young adults, supporting the drug's safety and efficacy across various demographics[3].

Safety Considerations

While cabotegravir has shown a favorable safety profile, there are considerations such as residual concentrations remaining in the systemic circulation for prolonged periods, which could lead to HIV-1 acquisition and resistance if doses are missed. Additionally, there have been reports of hypersensitivity reactions and hepatotoxicity, necessitating careful monitoring and selection of patients[2].

Market Analysis

Market Impact of Long-Acting Therapies

The introduction of long-acting therapies like cabotegravir is expected to significantly impact the HIV treatment and prevention market. These therapies address a critical need for less frequent dosing, which can improve adherence and reduce the burden of daily treatment. The cost-effectiveness studies, such as those conducted in Canada, indicate that long-acting cabotegravir for PrEP can offer substantial cost savings and improvements in quality-adjusted life years compared to daily oral PrEP[5].

Patient Preferences and Adherence

Real-world data and surveys have shown that patients prefer long-acting injectable therapies due to their convenience and reduced stigma. The PILLAR implementation study, for example, demonstrated a reduction in stigma and anxiety among individuals using cabotegravir long-acting injectable PrEP[2].

Market Projections

Growing Demand for Long-Acting Therapies

The demand for long-acting HIV therapies is expected to grow as more patients and healthcare providers become aware of their benefits. The success of cabotegravir in clinical trials and real-world studies positions it as a leader in this market segment. As more data becomes available, the adoption of these therapies is likely to increase, driven by their superior efficacy, improved adherence, and enhanced quality of life for patients.

Economic and Public Health Impact

The economic and public health impact of cabotegravir is significant. By reducing the frequency of dosing and improving adherence, long-acting therapies can lead to better viral suppression rates, which in turn can reduce the transmission of HIV. Cost-effectiveness studies suggest that these therapies can offer substantial savings by reducing the need for frequent clinic visits and the associated healthcare costs[5].

Key Takeaways

  • Ultra Long-Acting Formulation: Cabotegravir ultra long-acting (CAB-ULA) has the potential to double the current dosing interval to at least every four months.
  • Superior Efficacy: Cabenuva (cabotegravir + rilpivirine) has shown superior efficacy in maintaining viral load suppression compared to daily oral therapy.
  • High Effectiveness in Real-World Studies: Apretude (cabotegravir long-acting) has demonstrated more than 99% effectiveness in preventing HIV acquisition in real-world studies.
  • Improved Adherence and Quality of Life: Long-acting therapies reduce the burden of daily treatment, improve adherence, and enhance quality of life by reducing stigma and anxiety.
  • Favorable Pharmacokinetics: Cabotegravir shows minimal differences in pharmacokinetic profiles across different age groups and genders.
  • Market Impact: Long-acting therapies are expected to significantly impact the HIV treatment and prevention market, offering cost savings and improvements in quality-adjusted life years.

FAQs

Q: What is the current dosing interval for cabotegravir ultra long-acting (CAB-ULA)?

A: The current dosing interval for CAB-ULA is at least every four months, doubling the previous interval[1].

Q: How effective is Apretude (cabotegravir long-acting) in real-world studies?

A: Apretude has shown more than 99% effectiveness in preventing HIV acquisition in real-world studies[2].

Q: What are the potential risks associated with cabotegravir?

A: Potential risks include residual concentrations leading to HIV-1 acquisition and resistance if doses are missed, hypersensitivity reactions, and hepatotoxicity[2].

Q: How does cabotegravir impact patient adherence?

A: Cabotegravir long-acting therapies improve adherence by reducing the frequency of dosing, which can be a significant barrier for many patients[4].

Q: What is the economic impact of cabotegravir long-acting therapies?

A: These therapies can offer substantial cost savings by reducing the need for frequent clinic visits and associated healthcare costs, as well as improving quality-adjusted life years[5].

Sources

  1. ViiV Healthcare. "ViiV Healthcare presents phase I clinical trial findings of a cabotegravir long-acting injectable investigational formulation allowing at least four months between doses." March 4, 2024.
  2. ViiV Healthcare. "ViiV Healthcare shows more than 99% effectiveness in real-world studies for Apretude (cabotegravir long-acting), the only approved long-acting HIV PrEP." October 16, 2024.
  3. Academic.oup.com. "Drug Exposure of Long-Acting Cabotegravir and Rilpivirine in Older Adults."
  4. ViiV Healthcare. "LATITUDE phase III interim trial data indicates ViiV Healthcare's long-acting injectable HIV treatment has superior efficacy compared to daily therapy in individuals living with HIV who have adherence challenges." February 21, 2024.
  5. ViiV Healthcare. "ViiV Healthcare expands on real-world data supporting use of long-acting therapies in diverse patient populations at HIV Glasgow." November 7, 2024.

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