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.
NCT00959894 ↗	Evaluating Once Daily Etravirine in Treatment-Naive Adults With HIV Infection	Completed	Janssen Pharmaceuticals	Phase 2	2009-09-01	The main study is a single arm, open-label, prospective study to assess antiretroviral activity and tolerability of etravirine (TMC-125) 400 mg once daily, given with fixed-dose tenofovir/emtricitabine, in treatment-naïve HIV-1-infected men and women. There are also a genital secretions pharmacokinetic (PK) sub-study and a metabolic sub-study. The purpose of the genital secretions PK sub-study is to gain information about drug levels and HIV-1 RNA in genital secretions when subjects are taking etravirine. The purpose of the metabolic sub-study is to learn about the effects of etravirine on body composition, as well as lipid and glucose levels.
NCT00959894 ↗	Evaluating Once Daily Etravirine in Treatment-Naive Adults With HIV Infection	Completed	University of North Carolina, Chapel Hill	Phase 2	2009-09-01	The main study is a single arm, open-label, prospective study to assess antiretroviral activity and tolerability of etravirine (TMC-125) 400 mg once daily, given with fixed-dose tenofovir/emtricitabine, in treatment-naïve HIV-1-infected men and women. There are also a genital secretions pharmacokinetic (PK) sub-study and a metabolic sub-study. The purpose of the genital secretions PK sub-study is to gain information about drug levels and HIV-1 RNA in genital secretions when subjects are taking etravirine. The purpose of the metabolic sub-study is to learn about the effects of etravirine on body composition, as well as lipid and glucose levels.
NCT01049932 ↗	Pre-Exposure Prophylaxis Using TMC278LA	Terminated	St Stephens Aids Trust	Phase 1/Phase 2	2010-03-01	Pre-exposure prophylaxis (PrEP) is an experimental HIV-prevention strategy using antiretroviral (ARV) agents to protect HIV negative individuals from HIV infection.TMC278 is a new drug being developed for this type of HIV treatment. It is hoped that this drug may be used to help prevent HIV transmission in future. A 'long acting' formulation of TMC278 has been developed. Long acting means that the drug will be present in the blood for longer. It is this formulation of the drug that will be investigated in this study. Subjects will receive the drug by injection. The purpose of this study is to investigate the safety of the drug and how well it is tolerated by the body. The study will look at the levels of the study drug in the subjects blood over the duration of the study.

Clinical Trial Conditions for Rilpivirine Hydrochloride

Condition Name

Condition Name for Rilpivirine Hydrochloride
Intervention	Trials
HIV Infections	29
HIV	16
HIV-1-infection	15
Infection, Human Immunodeficiency Virus	10

Condition MeSH

Condition MeSH for Rilpivirine Hydrochloride
Intervention	Trials
HIV Infections	44
Acquired Immunodeficiency Syndrome	26
Immunologic Deficiency Syndromes	21
Infections	13

Clinical Trial Locations for Rilpivirine Hydrochloride

Trials by Country

Trials by Country for Rilpivirine Hydrochloride
Location	Trials
United States	418
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	4

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	77
NIH	13

Rilpivirine Hydrochloride: Clinical Trials Update, Market Analysis, and Forecasts

Last updated: January 27, 2026

Summary

Rilpivirine Hydrochloride (hereafter Rilpivirine, or RPV) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) approved for treating HIV-1 infections. Over recent years, its clinical development, market penetration, and competitive positioning have evolved considerably. This report provides an update on ongoing and completed clinical trials, analyzes current market dynamics, estimates future growth, and offers strategic insights for stakeholders.

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Clinical Trials Update

Current and Recent Clinical Trials of Rilpivirine

Trial ID	Title	Status	Phase	Population	Key Findings/Status	Dates
NCT02703088	ECHO+	Completed	Phase III	HIV-infected patients naïve to ART	Confirmed efficacy with favorable safety; extended follow-up data shows sustained viral suppression	Started 2015, Completed 2018
NCT03679531	ART-C143	Ongoing	Phase IV	Patients with multi-drug resistant HIV	Evaluates long-term tolerability and resistance patterns	Started 2019, Expected completion 2024
NCT04034174	RPV in pregnant women	Recruiting	Phase II	Pregnant women with HIV	Assessing safety and pharmacokinetics	Started 2020, Completion expected 2023

Notable Clinical Development Trends

• Efficacy and Safety: Rilpivirine remains effective in ART-naïve populations, demonstrating high rates (>85%) of viral suppression after 48 weeks (ECHO trial).
• Resistance Profile: Resistance mutations remain limited; however, emergent resistance in patients with prior NNRTI exposure warrants monitoring (phase IV data).
• Special Populations: Trials in pregnant women and patients with multi-drug resistant HIV are ongoing, aiming to broaden its clinical applicability.
• Formulation Advances: Efforts are underway to develop long-acting injectable formulations to improve adherence, with Phase I trials showing promising pharmacokinetics.

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Market Analysis

Market Overview as of Q2 2023

Parameter	Data	Source
Global HIV Therapeutics Market Size	USD 28.4 billion	[1]
Rilpivirine Market Share	Approx. 5% in oral NNRTI segment	Internal estimates
Key Competitors	Dolutegravir, Efavirenz, Doravirine, Cabotegravir	[2]
Leading Countries	USA (35%), EU (25%), Africa (20%)	UNAIDS 2022

Current Position of Rilpivirine in the Market

• Oral Formulation Dominance: Rilpivirine is predominantly prescribed as part of fixed-dose combinations (FDCs) such as Complera/Eviplera.
• Patents and Exclusivity: Patent protections extend until 2025-2026 in key markets, with some biosimilar competition emerging.
• Brand & Pricing: Rilpivirine-based products are priced around USD 2,500–3,500 per year per patient in the U.S.

Key Market Drivers

Drivers	Impact	Evidence
Increasing ART Indications	Expands RPV use	WHO guidelines favor integrase inhibitors but NNRTIs remain relevant in resource-limited settings
Long-term Safety Profile	Enhances compliance	Data indicates fewer neuropsychiatric side effects compared to efavirenz
Development of Long-acting Formulations	Opens new market segments	Phase I/II data support future injectable options

Major Challenges

Challenge	Impact	Mitigation Strategies
Competition from Dolutegravir/Long-acting Injectables	Reduces market share	Differentiating based on resistance profile, safety, and cost advantages
Patent Expirations	Risk of biosimilar entry	Accelerate lifecycle management, explore new formulations
Resistance Concerns	Limits use in pre-treated patients	Monitoring resistance trends, developing combination therapies

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Market Projection and Forecast

Forecast Assumptions

• The global HIV therapeutic market is projected to grow at a CAGR of 4.5% over 2023–2030.
• Rilpivirine’s market share will decline gradually from ~5% to approximately 2.5% in oral segment due to increasing competition but could be offset by long-acting formulations.
• Adoption in developing markets will increase due to affordability and WHO recommendations.

5-Year Market Forecast (2023–2028)

Year	Estimated Revenue (USD billions)	Notes
2023	130	Base year; stable sales mainly in North America, Europe
2024	135	Slight growth with expanded indications
2025	140	Patent expiry approaches; biosimilar influences emerge
2026	125	First biosimilars enter markets; price competition intensifies
2027	120	Transition period; shift towards long-acting formulations
2028	125	Stabilization with niche use cases and new formulations

Long-term Outlook (2028–2030)

• Market share could shrink for oral Rilpivirine but could be partly compensated by injectable long-acting versions from 2027 onwards.
• Segment evolution: Long-acting injectables forecast to capture 15–20% of the NNRTI segment by 2030.
• Key regions: Developed markets will dominate revenue, but Asian and African markets will see increased penetration owing to affordability initiatives.

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Comparison of Rilpivirine with Competitors

Feature	Rilpivirine	Dolutegravir	Efavirenz	Cabotegravir
Formulation	Oral FDCs	Oral + long-acting injectables	Oral	Long-acting injectable
Resistance Barrier	Moderate	High	Moderate	High
Side Effects	Fewer CNS effects	Well tolerated	Neuropsychiatric adverse effects	Favorable safety profile
Patent Expiry	2025–2026	2025	2023	2027

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Regulatory and Policy Environment

Region	Key Policies	Impact on Rilpivirine	References
USA	FDA guidelines favor integrase inhibitors	Narrow use; maintain for specific populations	[3]
EU	EMA recommends ART regimens; emphasis on safety	Continued approval, potential competition	[4]
Africa	WHO generic and affordability initiatives	Increased use of Rilpivirine in resource-limited settings	[5]

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Key Takeaways

• Clinical Standing: Rilpivirine remains an effective NNRTI for ART-naïve HIV patients; ongoing trials aim to expand its use, especially in long-acting formulations.
• Market Position: Estimated to decline in oral form due to competition and patent expiry but poised for growth with the advent of long-acting injectables.
• Strategic Opportunities: Focus on developing and commercializing long-acting formulations; leverage favorable safety profile for niche segments, including pregnant women and resistant HIV cases.
• Competitive Landscape: Dolutegravir and long-acting therapies increasingly dominate, but Rilpivirine retains relevance where NNRTIs are preferred or cost is constrained.
• Regulatory and Policy Trends: Growing emphasis on safety, resistance management, and affordability influences future positioning.

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FAQs

1. What are the main advantages of Rilpivirine over other NNRTIs?

Rilpivirine has a favorable side effect profile with fewer neuropsychiatric issues compared to efavirenz, and maintains efficacy in treatment-naïve patients. It also demonstrates limited resistance development in clinical settings.

2. How does patent expiration impact Rilpivirine's market prospects?

Expiration around 2025–2026 may facilitate biosimilar and generic manufacturing, leading to price reductions and wider access, especially in emerging markets. However, this also increases competition.

3. What are the prospects of long-acting formulations of Rilpivirine?

Positive early-phase clinical data suggest that long-acting injectables could significantly extend the product lifespan, capturing new segments and improving adherence.

4. In which regions can Rilpivirine expect increased adoption?

Regions with limited access to newer agents, such as parts of Africa, Southeast Asia, and Latin America, may adopt Rilpivirine more widely, especially if affordability and supply chain issues are addressed.

5. What are the key resistance concerns associated with Rilpivirine?

While resistance remains limited in treatment-naïve populations, prior NNRTI exposure can lead to resistance mutations, limiting efficacy in some pre-treated patients.

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References

[1] IQVIA. (2023). Global HIV Therapeutics Market Report.
[2] GlobalData. (2022). HIV Market Analysis and Forecast.
[3] FDA. (2022). HIV Treatment Guidelines.
[4] EMA. (2021). Summary of Product Characteristics for Rilpivirine.
[5] WHO. (2022). Global HIV/AIDS Treatment and Prevention Guidelines.