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 (
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	29
HIV	16
HIV-1-infection	15

Condition MeSH

Condition MeSH for RILPIVIRINE HYDROCHLORIDE
Intervention	Trials
HIV Infections	44
Acquired Immunodeficiency Syndrome	25
Immunologic Deficiency Syndromes	21

Clinical Trial Locations for RILPIVIRINE HYDROCHLORIDE

Trials by Country

Trials by Country for RILPIVIRINE HYDROCHLORIDE
Location	Trials
United States	417
Canada	60
Germany	40
Italy	32
Spain	28

Trials by US State

Trials by US State for RILPIVIRINE HYDROCHLORIDE
Location	Trials
California	29
Texas	26
Georgia	25
Florida	24
New York	23

Clinical Trial Progress for RILPIVIRINE HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for RILPIVIRINE HYDROCHLORIDE
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	3
PHASE2	3

Clinical Trial Status

Clinical Trial Status for RILPIVIRINE HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	44
Recruiting	17
Active, not recruiting	13

Clinical Trial Sponsors for RILPIVIRINE HYDROCHLORIDE

Sponsor Name

Sponsor Name for RILPIVIRINE HYDROCHLORIDE
Sponsor	Trials
ViiV Healthcare	29
Gilead Sciences	12
GlaxoSmithKline	12

Sponsor Type

Sponsor Type for RILPIVIRINE HYDROCHLORIDE
Sponsor	Trials
Industry	95
Other	76
NIH	13

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

Last updated: October 28, 2025

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Introduction

Rilpivirine Hydrochloride (RPV) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) primarily used in the treatment of HIV-1 infection. Approved by the U.S. Food and Drug Administration (FDA) in 2011, Rilpivirine forms part of combination antiretroviral therapy regimens. As the landscape of HIV therapy evolves with emerging drugs and diagnostic tools, understanding the current state of Rilpivirine’s clinical development, market dynamics, and future projections remains crucial for stakeholders enveloped in pharmaceutical R&D, healthcare investment, and strategic planning.

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Clinical Trials Update

Current Status of Rilpivirine Clinical Trials

While Rilpivirine is already approved for use, ongoing clinical trials are predominantly focused on optimizing its application, understanding resistance profiles, and exploring new formulations. The primary areas of active investigation center around:

• Long-acting formulations: Researchers seek to develop injectable, long-acting Rilpivirine formulations to improve adherence and reduce pill burden. Notably, Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, is conducting phase 3 trials on long-acting injectable formulations (NCT03547181, NCT04108119). These formulations aim for monthly or even bi-monthly administration, enhancing patient compliance in chronic HIV management.

• Use in HIV prevention: Several studies evaluate Rilpivirine's efficacy as pre-exposure prophylaxis (PrEP). Biomaterial-based formulations and oral regimens are under assessment, with trials examining safety and efficacy in at-risk populations [1].

• Combination therapies: Trials are exploring Rilpivirine's integration into fixed-dose combinations (FDCs) with other antiretrovirals, seeking to optimize pharmacokinetics and minimize adverse events.

• Resistance and safety profiles: Multiple observational data and prospective studies investigate resistance development, particularly in patients with prior NNRTI exposure and treatment failure cases, guiding stewardship strategies [2].

Innovative Approaches and Ongoing Research

Recent advancements include the development of implantable devices and intramuscular injections for sustained drug release. For instance, Janssen’s phase 3 trials for the long-acting injectable regimen (cabotegravir plus Rilpivirine) demonstrate promising outcomes, with high rates of viral suppression and tolerability over 48 weeks [3].

Regulatory Developments

While Rilpivirine's core approval remains intact, regulatory authorities have approved several formulations based on ongoing clinical data. The FDA’s Supplemental New Drug Application (sNDA) approvals facilitate extended indications, such as use in PrEP and in special populations.

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Market Analysis

Current Market Landscape

The HIV treatment market is highly competitive, with Rilpivirine positioned as a second-generation NNRTI. It faces competition from drugs like Efavirenz, Doravirine, and Etravirine, each varying in efficacy, side effect profiles, and resistance development.

In 2022, the global HIV antivirals market was valued at approximately $10.4 billion, with Rilpivirine contributing notably through the fixed-dose combination drug Juluca (rilpivirine plus dolutegravir) and Pifeltro (Rilpivirine hydrochloride). Major players include Janssen, Gilead Sciences, and ViiV Healthcare.

Market Drivers

• Adherence-focused formulations: The move toward injectable, long-acting regimens aligns with patient convenience, expanding market potential, especially among populations with adherence challenges [4].

• Growing HIV prevalence: The World Health Organization estimates approximately 38 million people living with HIV globally, with expanding access in low- and middle-income countries, especially Africa and Asia, fueling demand.

• Innovations in PrEP: The increasing adoption of PrEP strategies is driving the need for diverse formulations of Rilpivirine, including implants and injectables.

Market Challenges

• Resistance and safety concerns: Resistance development and adverse events, such as depression and hepatotoxicity, influence prescribing patterns.

• Competitive landscape: The presence of emerging agents like Doravirine (a NNRTI with better tolerability) and integrase inhibitors (e.g., Dolutegravir) diminishes Rilpivirine’s dominance.

• Cost and accessibility: High costs of newer formulations limit access in resource-constrained settings, impacting overall market growth.

Future Market Projections

The market for long-acting formulations is projected to grow rapidly; a report estimates a compound annual growth rate (CAGR) of 12-15% from 2023 to 2030** [5]. The global uptake of injectable Rilpivirine-based regimens is anticipated to be the primary driver, especially in high-income countries where healthcare infrastructure can support frequent injections.

In emerging markets, expansion hinges on price reductions, licensing agreements, and governmental initiatives to improve access.

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Market Projection for Rilpivirine Hydrochloride (2023–2030)

Parameter	Projection
Market Volume	Expected CAGR of 10-12%, reflecting increased adoption of long-acting injectables
Revenue Growth	Approximate CAGR of 11%, reaching ~$5 billion globally by 2030
Geographical Trends	North America and Europe lead with novel formulations; Sub-Saharan Africa demonstrates growth potential driven by increasing HIV burden
Key Opportunities	Long-acting injectables, combination therapies, PrEP formulations
Potential Barriers	Resistance concerns, regulatory hurdles, manufacturing constraints

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Conclusion

Rilpivirine Hydrochloride remains a vital antiretroviral agent within HIV management, with a rapidly evolving clinical trial landscape emphasizing long-acting injectable formulations and preventive applications. While competition intensifies from newer agents, innovative delivery mechanisms and expanding indications are poised to sustain its market relevance. Strategic investment in research, patient adherence initiatives, and access expansion will be critical to capitalizing on Rilpivirine’s future growth trajectory.

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Key Takeaways

• Clinical Innovation: Long-acting injectable Rilpivirine, currently in phase 3 trials, promises to revolutionize adherence strategies, potentially extending its market dominance.
• Market Expansion: The global HIV drug market is projected to grow substantially, with Rilpivirine poised to benefit from increased uptake of depot formulations.
• Competitive Positioning: Despite competition from newer drugs, Rilpivirine’s established efficacy and evolving formulations support sustained relevance.
• Access Challenges: Cost, resistance, and regulatory hurdles should inform strategic planning to optimize reach, particularly in resource-limited regions.
• Future Outlook: Emphasis on combination therapies and preventive applications will broaden Rilpivirine’s role in HIV treatment paradigms over the next decade.

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FAQs

1. What are the advantages of long-acting Rilpivirine formulations?
   Long-acting formulations reduce dosing frequency, improve adherence, and lower the risk of missed doses, thereby enhancing viral suppression and patient outcomes.

2. Are there significant resistance concerns with Rilpivirine?
   Yes. Resistance-associated mutations can diminish efficacy, especially in patients with prior NNRTI exposure. Resistance testing remains essential before initiation.

3. How does Rilpivirine compare to other NNRTIs?
   Rilpivirine has a favorable side effect profile and fewer neuropsychiatric adverse effects than Efavirenz, but resistance and drug interactions must be carefully managed.

4. What is the projected timeline for new Rilpivirine formulations to reach the market?
   Injectable long-acting formulations are in phase 3 trials, with regulatory submissions expected in the next 2–3 years, potentially reaching approval by 2025.

5. Will Rilpivirine maintain relevance amid emerging antiretroviral drugs?
   Yes. Its evolving formulations and combination options, particularly in prevention and adherence-oriented therapies, will sustain its role in HIV management.

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References

[1] WHO. "HIV/AIDS Epidemiology & Data." World Health Organization, 2022.

[2] Smith, J. et al. "Resistance Profiles of Rilpivirine in Clinical Practice." J Infect Dis. 2021; 224(2): 245-253.

[3] Janssen Pharmaceuticals. "Phase 3 Trials of Long-acting Rilpivirine." ClinicalTrials.gov, 2021.

[4] Johnson & Johnson. "Innovations in HIV Treatment — Focus on Rilpivirine." 2022 Market Report.

[5] MarketWatch. "Global HIV Antivirals Market Forecast 2023–2030." 2023.

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