CLINICAL TRIALS PROFILE FOR RILPIVIRINE HYDROCHLORIDE

All Clinical Trials for Rilpivirine Hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00537966 ↗	Characterization of Acute and Recent HIV-1 Infections in Zurich: a Long-term Observational Study	Recruiting	University of Zurich	N/A	2002-01-01	Aim of the study: To describe the epidemiology, longitudinally follow, test the effect of early antiretroviral treatment and investigate early events of virus-host interactions in patients with documented acute or recent HIV-1 infection in Zurich. Study design: This is an open label, non-randomized, observational, single center study at the University Hospital Zurich, Division of Infectious Diseases and Hospital Epidemiology. We aim at enrolling approximately 300 patients over a 10 year period. All patients who fulfill the inclusion criteria of a documented acute or recent HIV infection can participate in the study. Patients are offered early combination antiretroviral treatment (cART), if treatment start falls within 90 days after diagnosis of acute HIV-infection. After one year of suppressed HIV-plasma viremia (< 50 copies/ml) patients can chose to stop cART. Patients who have not chosen to undergo early-cART, respectively will stop cART after one year will be followed for a total of 5 years. Viral setpoints reached after treatment interruptions will be compared to historic controls and to the control group not having received cART during acute infection. A battery of virological and immunological assays will be performed on blood samples obtained to better understand early virus-host interactions, which are thought to play a key role in HIV-pathogenesis research. Summary: In summary, this study will provide comprehensive knowledge on early HIV-infection with regard to epidemiology, impact of early-cART on the course of disease and forms the base for a variety of translational research projects addressing early key pathogenesis events between virus and host, relevant for the course of disease, for transmission, for development of vaccines and new treatment strategies. - Trial with medicinal product
NCT00799864 ↗	A Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Antiviral Activity of Rilpivirine (TMC278) in Human Immunodeficiency Virus Infected Adolescents and Children Aged Greater Than or Equal to 6 Years	Recruiting	Janssen Sciences Ireland UC	Phase 2	2011-01-07	The purpose of this study is to evaluate the pharmacokinetics, safety and antiviral activity of rilpivirine (TMC278) 25 milligram (mg) or adjusted dose once daily in combination with an investigator-selected background regimen containing 2 nucleoside/nucleotide reverse transcriptase inhibitors (N[t]RTIs) (zidovudine [AZT], abacavir [ABC], or tenofovir disoproxil fumarate [TDF] in combination with lamivudine [3TC] or emtricitabine [FTC] in antiretroviral (ARV) treatment-naïve adolescents and children aged greater than or equal to (>=) 6 to less than (<) 18 years.
NCT00855335 ↗	A Single-arm, Open-label, Study to Assess the Pharmacokinetics of Darunavir and Ritonavir, Darunavir and Cobicistat, Etravirine, and Rilpivirine in HIV-1 Infected Pregnant Women	Completed	Janssen Scientific Affairs, LLC	Phase 3	2009-04-09	The purpose of this study is to study how changes in the body during pregnancy influence the blood levels of TMC114 (darunavir) and ritonavir taken together, darunavir and cobicistat taken as a fixed-dose combination, TMC125 (etravirine) taken alone or with darunavir and ritonavir or rilpivirine in patients with human immunodeficiency virus-1 (HIV-1). This study will examine how these drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time. Any pregnant woman who is currently receiving darunavir with ritonavir, darunavir with cobicistat, etravirine or rilpivirine for HIV-1, and who meets the eligibility criteria for the study, will be allowed to enroll. Patients must be willing to remain on study medication during the course of their pregnancy, and 12 weeks postpartum. The information collected may help answer questions about how to best prescribe these three drugs for pregnant women.

Clinical Trial Conditions for Rilpivirine Hydrochloride

Condition Name

Condition Name for Rilpivirine Hydrochloride
Intervention	Trials
HIV Infections	27
HIV	14
HIV-1-infection	12

Condition MeSH

Condition MeSH for Rilpivirine Hydrochloride
Intervention	Trials
HIV Infections	42
Acquired Immunodeficiency Syndrome	24
Immunologic Deficiency Syndromes	21

Clinical Trial Locations for Rilpivirine Hydrochloride

Trials by Country

Trials by Country for Rilpivirine Hydrochloride
Location	Trials
United States	383
Canada	58
Germany	39
Italy	30
South Africa	25

Trials by US State

Trials by US State for Rilpivirine Hydrochloride
Location	Trials
California	26
Georgia	24
Texas	24
Florida	22
New York	21

Clinical Trial Progress for Rilpivirine Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Rilpivirine Hydrochloride
Clinical Trial Phase	Trials
Phase 4	21
Phase 3	28
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for Rilpivirine Hydrochloride
Clinical Trial Phase	Trials
Completed	43
Active, not recruiting	13
Recruiting	11

Clinical Trial Sponsors for Rilpivirine Hydrochloride

Sponsor Name

Sponsor Name for Rilpivirine Hydrochloride
Sponsor	Trials
ViiV Healthcare	25
Gilead Sciences	12
Janssen Pharmaceuticals	11

Sponsor Type

Sponsor Type for Rilpivirine Hydrochloride
Sponsor	Trials
Industry	87
Other	70
NIH	12

Rilpivirine Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction to Rilpivirine Hydrochloride

Rilpivirine hydrochloride, known by the brand name Edurant, is a crucial antiretroviral medication used in the treatment of HIV-1 infection. It is often used in combination with other antiretroviral agents to manage the condition effectively.

Clinical Trials Overview

ATLAS Study

The ATLAS (Antiretroviral Therapy as Long-Acting Suppression) study is a pivotal phase III trial conducted by ViiV Healthcare. This study evaluated the efficacy and safety of a long-acting, injectable two-drug regimen of cabotegravir and rilpivirine compared to a standard daily oral three-drug regimen. The results showed that the injectable regimen had similar efficacy to the oral regimen at 48 weeks, meeting the primary endpoint for non-inferiority[1].

FLAIR and Other Trials

In addition to the ATLAS study, the FLAIR trial also assessed the long-acting injectable regimen of cabotegravir and rilpivirine, but in treatment-naïve individuals. These trials, along with ATLAS-2M and SOLAR, have provided comprehensive data on the virologic outcomes and safety of this regimen. A large-scale post hoc analysis pooling data from over 2,500 participants across these trials further reinforced the efficacy and real-world utility of the cabotegravir and rilpivirine long-acting (CAB+RPV LA) regimen[3].

Market Analysis

Market Size and Growth

The global Rilpivirine Hydrochloride Market is projected to experience significant growth during the forecast period. This growth is driven by the increasing demand for effective and well-tolerated HIV/AIDS treatments. The market is expected to expand at a steady CAGR, with the North American and European regions anticipated to dominate due to their high prevalence of HIV/AIDS and well-established healthcare infrastructure[2][5].

Regional Dynamics

• North America: This region is expected to lead the market due to the high prevalence of HIV/AIDS, robust regulatory frameworks, and widespread awareness among healthcare providers and patients.
• Europe: Countries like Germany, the UK, and France will contribute significantly to the market growth, thanks to their well-developed healthcare systems and strong emphasis on HIV/AIDS management.
• Asia-Pacific: This region is expected to experience moderate growth, driven by the increasing prevalence of HIV/AIDS and the expansion of healthcare infrastructure.
• Latin America and Middle East & Africa: These regions are anticipated to have a smaller but growing share of the market as they develop their healthcare systems and address the burden of HIV/AIDS[2][5].

Market Opportunities

The Rilpivirine Hydrochloride Market presents several opportunities for growth, including:

• Increasing Demand: The persistent need for effective HIV/AIDS treatments, especially in low- and middle-income countries, drives the demand for rilpivirine hydrochloride.
• Technological Advancements: Ongoing research and development in antiretroviral therapies offer potential for new and improved treatment options.
• Diverse Applications: Rilpivirine hydrochloride is used in both treatment-naïve and treatment-experienced individuals, expanding its market reach[2][5].

Market Dynamics

Competitive Landscape

The market is moderately competitive, with both branded and generic manufacturers focusing on product quality, regulatory compliance, and effective distribution channels. Key players in the market include ViiV Healthcare and Janssen Sciences Ireland UC, among others[2][5].

Challenges and Drivers

• Drivers: The high prevalence of HIV/AIDS, the availability of well-established healthcare infrastructure, and the presence of leading pharmaceutical companies in key regions drive the market.
• Challenges: The market faces challenges such as the need for continuous regulatory compliance, the impact of COVID-19 on healthcare systems, and the varying healthcare infrastructure across different regions[5].

Real-World Utilization

Adherence and Persistence

Real-world data from patient support programs, such as those in Canada, have shown promising results in terms of adherence and persistence with the CAB+RPV LA regimen. These analyses highlight the practical benefits of this long-acting injectable treatment in diverse patient populations[3].

Future Outlook

The future outlook for the Rilpivirine Hydrochloride Market remains promising. The market is expected to continue its steady growth trajectory, driven by the persistent need for effective HIV/AIDS treatments and technological advancements. The North American and European regions are anticipated to maintain their dominance, while the Asia-Pacific region is expected to experience moderate growth[2][5].

Key Takeaways

• Clinical Trials: The ATLAS and FLAIR studies have demonstrated the efficacy and safety of the long-acting injectable regimen of cabotegravir and rilpivirine.
• Market Growth: The global Rilpivirine Hydrochloride Market is expected to grow significantly, driven by increasing demand for effective HIV/AIDS treatments.
• Regional Dynamics: North America and Europe will dominate the market, with the Asia-Pacific region showing moderate growth.
• Market Opportunities: The market offers opportunities for growth through increasing demand, technological advancements, and diverse applications.
• Real-World Utilization: Real-world data supports the adherence and persistence of the CAB+RPV LA regimen.

FAQs

What is the primary use of Rilpivirine Hydrochloride in HIV treatment?

Rilpivirine hydrochloride is used in combination with other antiretroviral agents to treat HIV-1 infection, both in treatment-naïve and treatment-experienced individuals.

What are the key findings from the ATLAS study?

The ATLAS study showed that the long-acting injectable regimen of cabotegravir and rilpivirine had similar efficacy to a standard daily oral three-drug regimen at 48 weeks, meeting the primary endpoint for non-inferiority.

Which regions are expected to dominate the Rilpivirine Hydrochloride Market?

North America and Europe are anticipated to dominate the market due to the high prevalence of HIV/AIDS and well-established healthcare infrastructure.

What are the main drivers of the Rilpivirine Hydrochloride Market growth?

The main drivers include the increasing demand for effective HIV/AIDS treatments, technological advancements, and the presence of leading pharmaceutical companies in key regions.

How does the real-world utilization of CAB+RPV LA support its efficacy?

Real-world data from patient support programs have shown promising results in terms of adherence and persistence with the CAB+RPV LA regimen, highlighting its practical benefits in diverse patient populations.

Sources

1. ViiV Healthcare. ViiV Healthcare reports positive 48-week results for first pivotal, phase III study for novel, long-acting, injectable HIV-treatment regimen. August 15, 2018.
2. Data Horizon Research. Rilpivirine Hydrochloride Market Size, Share, Growth, Statistics.
3. ViiV Healthcare. ViiV Healthcare expands on real-world data supporting use of long-acting injectable Vocabria + Rekambys (cabotegravir + rilpivirine LA). November 7, 2024.
4. Clinical Trials EU. Rilpivirine Hydrochloride: A Comprehensive Guide for Patients with HIV.
5. Stratagem Market Insights. Rilpivirine Hydrochloride Market Insight, Size, Share, Growth, Up-To-Date Key Trends, Regional Outlook, and Forecast - 2030. June 2023.