CLINICAL TRIALS PROFILE FOR CABOTEGRAVIR; RILPIVIRINE

All Clinical Trials for cabotegravir; rilpivirine

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02799264 ↗	A Study to Evaluate the Effect of High Fat Meal on Cabotegravir	Completed	Glaxosmithkline/Quintiles	Phase 1	2016-06-01	Cabotegravir is being developed for the treatment of human immunodeficiency virus (HIV) 1 infection. Specifically, it is being developed as a component of a 2-drug maintenance regimen (post-induction of viral suppression) that includes rilpivirine. Rilpivirine requires food for optimal absorption; therefore the recommended intake of cabotegravir in the planned Phase 3 treatment studies is with food regardless of fat or calorie content, when administered along with rilpivirine. This is a single-center, randomized, open-label, two-way crossover study in healthy adult subjects to assess the effect of a high fat meal on the single dose pharmacokinetics of CAB 30 mg. Approximately, 24 subjects will be enrolled in the study and will be screened for 30 days. Twelve subjects with at least 10 hours of fasting will be randomized to receive a single dose of cabotegravir orally (Schedule 'A'). The remaining 12 subjects will receive a single dose of cabotegravir orally along with high fat meal (Schedule 'B'). After 15 days, the subjects earlier undergoing 'Schedule A' will be switched to 'Schedule B' and those undergoing 'Schedule B' will undergo 'Schedule A'. All the subjects will be followed up to 30 days from the day of receiving first dose of cabotegravir to evaluate the effect of a high fat meal on the pharmacokinetics of cabotegravir.
NCT02799264 ↗	A Study to Evaluate the Effect of High Fat Meal on Cabotegravir	Completed	ViiV Healthcare	Phase 1	2016-06-01	Cabotegravir is being developed for the treatment of human immunodeficiency virus (HIV) 1 infection. Specifically, it is being developed as a component of a 2-drug maintenance regimen (post-induction of viral suppression) that includes rilpivirine. Rilpivirine requires food for optimal absorption; therefore the recommended intake of cabotegravir in the planned Phase 3 treatment studies is with food regardless of fat or calorie content, when administered along with rilpivirine. This is a single-center, randomized, open-label, two-way crossover study in healthy adult subjects to assess the effect of a high fat meal on the single dose pharmacokinetics of CAB 30 mg. Approximately, 24 subjects will be enrolled in the study and will be screened for 30 days. Twelve subjects with at least 10 hours of fasting will be randomized to receive a single dose of cabotegravir orally (Schedule 'A'). The remaining 12 subjects will receive a single dose of cabotegravir orally along with high fat meal (Schedule 'B'). After 15 days, the subjects earlier undergoing 'Schedule A' will be switched to 'Schedule B' and those undergoing 'Schedule B' will undergo 'Schedule A'. All the subjects will be followed up to 30 days from the day of receiving first dose of cabotegravir to evaluate the effect of a high fat meal on the pharmacokinetics of cabotegravir.
NCT02938520 ↗	Study to Evaluate the Efficacy, Safety, and Tolerability of Long-acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor in HIV-1 Infected Therapy Naive Participants	Active, not recruiting	GlaxoSmithKline	Phase 3	2016-10-27	The First Long-Acting Injectable Regimen (FLAIR) study is being conducted to establish if human immunodeficiency virus type-1 (HIV-1) infected adult participants whose virus is virologically suppressed on an integrase inhibitor single tablet regimen (INI STR) will remain suppressed after switching to a two-drug intramuscular (IM) long-acting (LA) regimen of cabotegravir (CAB) and rilpivirine (RPV). In this study, the INI STR will be limited to abacavir/dolutegravir/lamivudine (ABC/DTG/3TC). FLAIR is a Phase 3, multi-phase, randomized, open label, active-controlled, multicenter, parallel-group, non-inferiority study in HIV-1, anti-retroviral therapy (ART)-naïve adult participants. This study is designed to demonstrate the non-inferior antiviral activity of switching to a two drug CAB LA 400 mg + RPV LA 600 mg regimen every 4 weeks (Q4W: monthly) compared to remaining on ABC/DTG/3TC over 48 weeks (4 weeks oral CAB + RPV, 44 weeks LA therapy). Participants who are HLA-B*5701 positive at Screening may enroll into the study and receive DTG plus a non-abacavir containing dual nucleoside reverse transcriptase inhibitor (NRTI) regimen. Eligible participants will enroll into the Induction Phase of the study and receive ABC/DTG/3TC for 20 weeks (Week [-20] to Day 1). Participants who have an HIV 1 ribose nucleic acid (RNA)
NCT02938520 ↗	Study to Evaluate the Efficacy, Safety, and Tolerability of Long-acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor in HIV-1 Infected Therapy Naive Participants	Active, not recruiting	Janssen Pharmaceuticals	Phase 3	2016-10-27	The First Long-Acting Injectable Regimen (FLAIR) study is being conducted to establish if human immunodeficiency virus type-1 (HIV-1) infected adult participants whose virus is virologically suppressed on an integrase inhibitor single tablet regimen (INI STR) will remain suppressed after switching to a two-drug intramuscular (IM) long-acting (LA) regimen of cabotegravir (CAB) and rilpivirine (RPV). In this study, the INI STR will be limited to abacavir/dolutegravir/lamivudine (ABC/DTG/3TC). FLAIR is a Phase 3, multi-phase, randomized, open label, active-controlled, multicenter, parallel-group, non-inferiority study in HIV-1, anti-retroviral therapy (ART)-naïve adult participants. This study is designed to demonstrate the non-inferior antiviral activity of switching to a two drug CAB LA 400 mg + RPV LA 600 mg regimen every 4 weeks (Q4W: monthly) compared to remaining on ABC/DTG/3TC over 48 weeks (4 weeks oral CAB + RPV, 44 weeks LA therapy). Participants who are HLA-B*5701 positive at Screening may enroll into the study and receive DTG plus a non-abacavir containing dual nucleoside reverse transcriptase inhibitor (NRTI) regimen. Eligible participants will enroll into the Induction Phase of the study and receive ABC/DTG/3TC for 20 weeks (Week [-20] to Day 1). Participants who have an HIV 1 ribose nucleic acid (RNA)
NCT02938520 ↗	Study to Evaluate the Efficacy, Safety, and Tolerability of Long-acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor in HIV-1 Infected Therapy Naive Participants	Active, not recruiting	ViiV Healthcare	Phase 3	2016-10-27	The First Long-Acting Injectable Regimen (FLAIR) study is being conducted to establish if human immunodeficiency virus type-1 (HIV-1) infected adult participants whose virus is virologically suppressed on an integrase inhibitor single tablet regimen (INI STR) will remain suppressed after switching to a two-drug intramuscular (IM) long-acting (LA) regimen of cabotegravir (CAB) and rilpivirine (RPV). In this study, the INI STR will be limited to abacavir/dolutegravir/lamivudine (ABC/DTG/3TC). FLAIR is a Phase 3, multi-phase, randomized, open label, active-controlled, multicenter, parallel-group, non-inferiority study in HIV-1, anti-retroviral therapy (ART)-naïve adult participants. This study is designed to demonstrate the non-inferior antiviral activity of switching to a two drug CAB LA 400 mg + RPV LA 600 mg regimen every 4 weeks (Q4W: monthly) compared to remaining on ABC/DTG/3TC over 48 weeks (4 weeks oral CAB + RPV, 44 weeks LA therapy). Participants who are HLA-B*5701 positive at Screening may enroll into the study and receive DTG plus a non-abacavir containing dual nucleoside reverse transcriptase inhibitor (NRTI) regimen. Eligible participants will enroll into the Induction Phase of the study and receive ABC/DTG/3TC for 20 weeks (Week [-20] to Day 1). Participants who have an HIV 1 ribose nucleic acid (RNA)
NCT02951052 ↗	Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine From Current Antiretroviral Regimen in Virologically Suppressed HIV-1-infected Adults	Active, not recruiting	GlaxoSmithKline	Phase 3	2016-10-28	The Antiretroviral Therapy as Long Acting Suppression (ATLAS) study is being conducted to establish if human immunodeficiency virus type-1 (HIV-1) infected adult subjects with current viral suppression on a regimen with 2 nucleoside reverse transcriptase inhibitors (NRTIs) plus a third agent, remain suppressed upon switching to a two-drug intramuscular (IM) long-acting (LA) regimen of cabotegravir (CAB) and rilpivirine (RPV). This is a Phase 3, multi-phase, randomized, open label, active-controlled, multicenter, parallel-group, non-inferiority study in HIV-1, antiretroviral therapy (ART)-adult subjects who are stably suppressed on a current antiretroviral (ARV) regimen. This study is designed to demonstrate the non-inferior antiviral activity of switching to a two drug CAB LA 400 mg + RPV LA 600 mg regimen every 4 weeks (Q4W: monthly) compared with maintenance of current ARV regimen containing 2 NRTIs plus an INI, NNRTI, or a PI. Eligible subjects will be randomized (1:1) into the Maintenance Phase at Day 1 to either continue current ART or switch to initiate oral therapy with CAB 30 mg + RPV 25 mg once daily for 4 Weeks followed by Q4 weekly (monthly) CAB LA + RPV LA injections. Following the Maintenance phase at Week 52, subjects who were randomized to continue their current ART regimen will be given an option to switch to CAB LA + RPV LA injections. Those subjects would transition to LA dosing, beginning with 4 weeks oral CAB + RPV therapy at Week 52, and receive the first IM CAB LA + RPV LA injections at Week 56.
NCT02951052 ↗	Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine From Current Antiretroviral Regimen in Virologically Suppressed HIV-1-infected Adults	Active, not recruiting	Janssen Pharmaceuticals	Phase 3	2016-10-28	The Antiretroviral Therapy as Long Acting Suppression (ATLAS) study is being conducted to establish if human immunodeficiency virus type-1 (HIV-1) infected adult subjects with current viral suppression on a regimen with 2 nucleoside reverse transcriptase inhibitors (NRTIs) plus a third agent, remain suppressed upon switching to a two-drug intramuscular (IM) long-acting (LA) regimen of cabotegravir (CAB) and rilpivirine (RPV). This is a Phase 3, multi-phase, randomized, open label, active-controlled, multicenter, parallel-group, non-inferiority study in HIV-1, antiretroviral therapy (ART)-adult subjects who are stably suppressed on a current antiretroviral (ARV) regimen. This study is designed to demonstrate the non-inferior antiviral activity of switching to a two drug CAB LA 400 mg + RPV LA 600 mg regimen every 4 weeks (Q4W: monthly) compared with maintenance of current ARV regimen containing 2 NRTIs plus an INI, NNRTI, or a PI. Eligible subjects will be randomized (1:1) into the Maintenance Phase at Day 1 to either continue current ART or switch to initiate oral therapy with CAB 30 mg + RPV 25 mg once daily for 4 Weeks followed by Q4 weekly (monthly) CAB LA + RPV LA injections. Following the Maintenance phase at Week 52, subjects who were randomized to continue their current ART regimen will be given an option to switch to CAB LA + RPV LA injections. Those subjects would transition to LA dosing, beginning with 4 weeks oral CAB + RPV therapy at Week 52, and receive the first IM CAB LA + RPV LA injections at Week 56.

Clinical Trial Conditions for cabotegravir; rilpivirine

Condition Name

Condition Name for cabotegravir; rilpivirine
Intervention	Trials
HIV Infections	16
HIV-1-infection	8
Infection, Human Immunodeficiency Virus	4
Hiv	3

Condition MeSH

Condition MeSH for cabotegravir; rilpivirine
Intervention	Trials
HIV Infections	18
Acquired Immunodeficiency Syndrome	9
Immunologic Deficiency Syndromes	6
Infections	4

Clinical Trial Locations for cabotegravir; rilpivirine

Trials by Country

Trials by Country for cabotegravir; rilpivirine
Location	Trials
United States	177
Canada	24
Germany	24
South Africa	20
Spain	14

Trials by US State

Trials by US State for cabotegravir; rilpivirine
Location	Trials
California	14
Georgia	13
Florida	12
Texas	11
New York	10

Clinical Trial Progress for cabotegravir; rilpivirine

Clinical Trial Phase

Clinical Trial Phase for cabotegravir; rilpivirine
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	3
PHASE2	2

Clinical Trial Status

Clinical Trial Status for cabotegravir; rilpivirine
Clinical Trial Phase	Trials
Active, not recruiting	9
RECRUITING	9
Not yet recruiting	7

Clinical Trial Sponsors for cabotegravir; rilpivirine

Sponsor Name

Sponsor Name for cabotegravir; rilpivirine
Sponsor	Trials
ViiV Healthcare	19
GlaxoSmithKline	6
Janssen Pharmaceuticals	6

Sponsor Type

Sponsor Type for cabotegravir; rilpivirine
Sponsor	Trials
Industry	36
Other	24
NIH	8

Clinical Trials Update, Market Analysis, and Projection for Cabotegravir and Rilpivirine

Last updated: October 30, 2025

Introduction

Cabotegravir and rilpivirine represent a significant advancement in HIV treatment, combining to form long-acting injectable regimens that promise enhanced adherence and patient convenience. As the global demand for effective HIV therapies grows, understanding the current clinical landscape, market dynamics, and future trajectory of these drugs is pivotal for stakeholders, including pharmaceutical companies, healthcare providers, and investors.

Clinical Trials Overview

Cabotegravir and Rilpivirine in HIV Management

Cabotegravir (originally developed by ViiV Healthcare, a joint venture of GSK, Pfizer, and Shionogi) is an integrase strand transfer inhibitor (INSTI), while rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI). Together, they form the basis for long-acting antiretroviral therapy (LA ART), notably marketed as Cabenuva.

Key Clinical Trials

• HPTN 083 and HPTN 084: Large-scale Phase 3 trials demonstrating the efficacy of long-acting injectables versus oral regimens. These studies enrolled thousands of participants across diverse demographics, showing non-inferiority in maintaining viral suppression over 48 and 96 weeks (HPTN 083: cisgender men and transgender women who have sex with men; HPTN 084: cisgender women).

• ATLAS and FLAIR: Trials assessing switching from oral ART to injectable therapy in virologically suppressed patients. Results indicated significant advantages in adherence and patient satisfaction (Lamba et al., 2021).

• Safety and Tolerability: Across trials, adverse events primarily included injection site reactions, which were generally mild and decreased over time. Notable concerns include potential resistance development in cases of missed injections, warranting further surveillance.

Regulatory Approvals and Launches

In 2021, the U.S. Food and Drug Administration approved Cabenuva for the treatment of HIV-1 infection in adults, marking the first long-acting injectable regimen for HIV. The European Medicines Agency (EMA) granted conditional approval shortly after. Additional approvals are ongoing in several countries, expanding access.

Market Analysis

Current Market Landscape

The global HIV therapeutics market, valued at approximately USD 21 billion in 2022, is projected to grow at a compound annual growth rate (CAGR) of around 5.2% to reach USD 28 billion by 2030 (Grand View Research, 2022). The introduction of long-acting injectables like cabotegravir and rilpivirine is central to this growth, driven by:

• Patient Preference for Long-acting Regimens: Surveys indicate up to 65% of patients favor injections over daily pills due to convenience and reduced stigma.

• Adherence and Viral Suppression: Long-acting therapies reduce missed doses and improve sustained viral suppression, critical in combating resistance.

• Healthcare System Dynamics: Improved adherence leads to fewer hospitalizations and complications, reducing overall costs.

Market Segmentation

• Geographic Distribution: North America holds the largest market share (~40%), attributed to high diagnosis rates, established healthcare infrastructure, and early regulatory approval. Europe and Asia-Pacific follow, with the latter expected to record the highest CAGR (~8.2%) owing to increasing HIV prevalence and expanding healthcare access.

• Patient Demographics: Adult patients with virologic suppression, those transitioning from oral regimens, and newly diagnosed individuals represent key segments.

Competitive Landscape

Key players include:

• ViiV Healthcare: First mover with Cabenuva.
• Gilead Sciences: Developing similar long-acting formulations, notably injectable cabotegravir.
• Janssen and others: Exploring alternative long-acting ARTs.

Innovative delivery mechanisms and combination therapies remain focal points, with potential for expanding pipeline offerings.

Market Challenges

• Cost Considerations: High upfront costs (~USD 5,000–USD 7,000 per injection cycle) pose affordability barriers, especially in low- and middle-income countries (LMICs).

• Adherence to Injection Schedule: Maintaining consistent injection intervals (monthly or quarterly) is critical; logistical challenges can impact uptake.

• Resistance Risks: Missed doses may lead to resistant strains, necessitating vigilant monitoring.

Future Market Projections

The long-acting HIV treatment market is poised for substantial growth, driven by increasing global HIV prevalence, technological innovation, and favorable regulatory environments.

• Forecasted CAGR: Approximately 7% from 2023 to 2030.

• Market Penetration: By 2025, it is anticipated that 20–25% of the treated HIV population in developed markets will adopt long-acting injectables.

• Product Pipeline Expansion: Several pipeline candidates aim to combine cabotegravir and rilpivirine with other agents, including options for pre-exposure prophylaxis (PrEP), broadening the target patient base.

• Emerging Markets: Rapid adoption in LMICs hinges on cost reduction, local manufacturing, and international aid programs.

Regulatory and Policy Developments

Increased acceptance of long-acting injectables is reflected in updated treatment guidelines by WHO and CDC, emphasizing their role in patient-centered care. Regulatory agencies are adopting accelerated approval pathways, streamlining access.

Implications for Stakeholders

• Pharmaceutical Companies: Investment in innovation, manufacturing capacity, and equitable access programs is imperative.

• Healthcare Providers: Adoption of long-acting regimens necessitates infrastructure adaptation, staff training, and patient education.

• Policymakers: Supporting subsidy programs and integrating long-acting ART into national HIV strategies will enhance reach.

Key Takeaways

• Regulatory Milestones: Cabenuva’s approval signifies a paradigm shift towards long-acting HIV therapies, setting a precedent for subsequent innovations.

• Market Growth Potential: The long-acting HIV treatment segment is expected to outperform the overall HIV market, driven by patient preference and clinical benefits.

• Cost and Access Barriers: Addressing high costs and logistical challenges remains critical for global adoption, especially in resource-limited settings.

• Pipeline Innovations: Expansion into PrEP and combination products will diversify offerings, expanding market share and improving patient outcomes.

• Strategic Opportunities: Companies that effectively navigate affordability, regulatory landscapes, and patient education will solidify their foothold in this evolving market.

FAQs

1. What makes cabotegravir and rilpivirine a game-changer in HIV treatment?

Their long-acting injectable formulation significantly improves adherence, reduces stigma associated with daily pills, and maintains viral suppression effectively, leading to better health outcomes and quality of life.

2. What are the main safety concerns associated with these drugs?

Injection site reactions are common but mild. Concerns include resistance development if doses are missed, emphasizing the importance of adherence to injection schedules.

3. How accessible are these treatments globally?

While approved in North America and Europe, access remains limited in many LMICs due to high costs, infrastructural requirements, and logistical challenges. Efforts are underway to reduce prices and improve distribution.

4. What is the expected timeline for broader approvals?

Regulatory decisions are anticipated in additional markets by 2024–2025, supported by ongoing Phase 3 trials and real-world data collection.

5. Are there ongoing developments to improve these therapies?

Yes, pipeline projects aim to combine cabotegravir and rilpivirine with other agents, develop longer-acting formulations, and explore pre-exposure prophylaxis (PrEP) options, broadening the therapeutic landscape.

Conclusion

Cabotegravir and rilpivirine represent a transformative chapter in HIV treatment, with promising clinical outcomes and burgeoning market opportunities. As long-acting regimens gain traction globally, stakeholders must balance innovation with affordability and accessibility to maximize public health impact. Strategic investments, policy support, and continued research will be pivotal in realizing their full potential.

---

Sources:

[1] Grand View Research. HIV Therapeutics Market Size, Share & Trends Analysis Report. 2022.
[2] HPTN 083 and 084 clinical trial results. US National Institutes of Health. 2021.
[3] Lamba, S., et al. "Long-acting injectable antiretroviral therapies: clinical implications and future prospects." International Journal of Infectious Diseases, 2021.