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.
NCT01252940 ↗	Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor (PI) and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) to a Fixed-dose Tablet Containing Emtricitabine/Rilpivirine/Tenofovir DF	Completed	Gilead Sciences	Phase 3	2010-11-01	The purpose of this randomized, open-label, multicenter, active-controlled Phase 3b study is to evaluate the noninferiority of the emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) single-tablet regimen (STR; also referred to as fixed-dose regimen or fixed-dose tablet) relative to regimens consisting of a ritonavir-boosted protease inhibitor (PI+RTV) and two nucleoside reverse transcriptase inhibitors (NRTIs) in virologically suppressed, HIV-1 infected subjects. The FTC/RPV/TDF STR could offer an attractive treatment option to patients who wish to simplify dosing by reducing pill burden or to improve the tolerability of their treatment. Participants will be randomized into 2 groups, the FTC/RPV/TDF STR group, in which participants will switch treatment regimens at the start of the study, and the Stay on Baseline Regimen (SBR)/Delayed Switch group, in which participants will remain on their baseline regimen during the first 24 weeks of the study (designed to provide an initial active control), and may switch to the FTC/RPV/TDF STR at the Week 24 visit. After the 48-week study analysis period, participants may continue to receive the FTC/RPV/TDF STR per protocol before switching to a commercially available source.

Clinical Trial Conditions for Rilpivirine Hydrochloride

Condition Name

Condition Name for Rilpivirine Hydrochloride
Intervention	Trials
HIV Infections	29
HIV	16
HIV-1-infection	15
HIV-1 Infection	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 Market Analysis and Financial Projection

Last updated: April 25, 2026

RILPIVIRINE HYDROCHLORIDE: Clinical-Stage Update, Market Read-Through, and Forecast Framework

What is rilpivirine hydrochloride’s current clinical and regulatory posture?

Rilpivirine is an established oral non-nucleoside reverse transcriptase inhibitor (NNRTI) used in HIV-1 treatment. The available public record supports its marketed status across major geographies under HIV combination therapy regimens, including fixed-dose combinations (notably with other antiretrovirals). Rilpivirine’s development in the near term is largely characterized by regimen optimization (e.g., dose timing, food effect guidance, switch strategies), label lifecycle work (e.g., stability, bioequivalence, formulation enhancements), and periodic resistance/real-world performance assessments rather than broad, new phase-3 “de novo” programs.

No current, clearly identifiable “new active registration” late-stage program can be confirmed from the supplied information, so the correct posture for market and investment modeling is to treat rilpivirine as a mature product with incremental clinical activity and ongoing pharmacovigilance rather than as a late-stage pipeline asset.

How do the core label constraints shape dosing, adherence, and clinical outcomes?

The most commercially determinative clinical attributes of rilpivirine are not trial endpoints but real-world behavior and drug-drug interaction risks that affect adherence and durability of response. The label class constraints typically include:

• Food requirement for therapeutic plasma exposure (historically a key adherence driver for rilpivirine-containing regimens).
• DDI considerations for agents that alter CYP metabolism or absorption.
• Resistance barrier dynamics: NNRTI class resistance (especially virologic failure on prior NNRTI exposure) drives regimen selection and switching patterns.

These factors influence both trial-enrollment behavior (switching versus treatment-naive cohorts) and commercial demand (preference for regimens with simplified administration or reduced interaction burden).

What clinical trials are most likely to matter commercially (and how should they be weighted)?

For a mature HIV agent, the trials with the highest commercial impact are usually those that can change:

• Formulary inclusion (guideline committees and payer protocols)
• Switch eligibility (patients already suppressed on other regimens)
• Tolerability or adherence profiles (which affect discontinuation and time on therapy)
• Efficacy in specific resistance contexts (which drives switching and salvage use)

Because rilpivirine is already in routine care, the practical market question is how often new evidence shifts clinicians away from it (to integrase inhibitor based options) versus toward it (in specific patient subsets, tolerability switches, or where guideline pathways still include NNRTI options).

How big is the HIV market where rilpivirine competes, and what is the substitution risk profile?

What is the competitive landscape for NNRTI-based therapy?

Rilpivirine competes in HIV treatment where oral combination therapy is standard. The competitive pressure has structurally shifted toward integrase strand transfer inhibitors (INSTIs) in many guidelines due to potency, resistance profiles, tolerability, and dosing convenience. NNRTIs remain used, but share has generally faced substitution.

Commercial read-through for rilpivirine demand depends on:

• Line of therapy mix (first-line, switch, and second-line)
• Guideline preference shifts (INSTI-centric care)
• Patient-specific constraints (drug availability, comorbidity, resistance history)
• Payer formulary placement (tied to net price and budget impact)

Market segmentation logic for a projection model (asset-level)

A practical projection model for rilpivirine should segment demand into:

1. Treatment-naive initiations where NNRTI regimens still remain acceptable within local guidance and payer policies
2. Switch market from older backbone regimens to newer standards where rilpivirine-containing options are still permitted
3. Treatment-experienced use where prior response, resistance pattern, and regimen tolerability maintain eligibility

For mature NNRTIs, the biggest slope driver is not trial success but relative guideline preference and formulary incentives versus INSTIs.

What is the market outlook and forecast direction for rilpivirine?

Projection framework (base, bear, bull)

Without a verified, current clinical pipeline dataset and without supply of country-level pricing/volume history, the correct way to deliver a projection is to state a decision-grade directional forecast tied to known market dynamics: INSTI substitution pressure and the persistence of NNRTI use in certain payer and guideline corridors.

Scenario set for 2026 to 2030 (directional)

• Base case (moderate decline / plateau): Mature utilization continues in switch and constrained-choice settings; decline stabilizes due to residual formulary inertia and patient subsets who benefit from NNRTI profiles.
• Bear case (accelerated decline): Continued INSTI preference and formulary tightening reduce NNRTI share; net price pressure and channel consolidation accelerate volume loss.
• Bull case (stabilization): Switch eligibility remains broad and local formularies keep rilpivirine-containing options available; reduced discontinuation in certain adherence profiles helps defend share.

Directional expectation

Rilpivirine should be treated as a share-defended, slowly shrinking asset in most high-uptake settings, with the possibility of localized stabilization where NNRTI-containing regimens remain payer-preferred or where patient-specific factors preserve use.

Where is incremental value most likely to appear for rilpivirine in the next 24 to 48 months?

For a mature NNRTI, incremental value tends to come from:

• Lifecycle formulations and manufacturing efficiencies that protect gross margin
• Line-extension evidence that keeps it in switch pathways
• Resistance and adherence evidence that supports continued guideline inclusion
• Geography-specific procurement cycles that stabilize volumes

This is not a high-upside “new efficacy” story; it is a market access and positioning story.

Clinical trial watchlist: what to monitor (to drive valuation adjustments)?

A decision-grade clinical update for rilpivirine should be treated as “market access relevant” if it changes one of the following:

• Guideline recommendation strength (class-wide or regimen-specific inclusion)
• Switch criteria (eligibility expands or narrows)
• Safety or tolerability signal that affects discontinuation rates
• Resistance guidance that changes sequencing or salvage use

If a new program is not clearly late-stage and registration-oriented, the market impact remains limited to guideline lifecycle updates and real-world performance.

Key business implications

• Valuation lens: Treat rilpivirine as a mature branded antiretroviral with continuing demand but elevated substitution risk from INSTIs.
• Commercial underwriting: Most revenue risk is share compression and net price pressure rather than clinical failure.
• R&D lens: Near-term “clinical trial updates” should be weighted primarily for their ability to preserve market access, not for new mechanism validation.

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Key Takeaways

• Rilpivirine hydrochloride is a mature NNRTI used in HIV combination regimens; near-term clinical activity is primarily label, regimen, and switching evidence rather than new, high-impact late-stage trials.
• Market outlook is dominated by INSTI substitution, payer formulary placement, and dosing/adherence constraints tied to food and interaction risks.
• Forecast direction is most consistent with slow decline or plateau in many settings, with bear risk driven by formulary tightening and bull upside driven by maintained switch eligibility.

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FAQs

1) Is rilpivirine still used in first-line HIV treatment?

Yes in certain guideline and access environments where NNRTI-based regimens remain acceptable, but overall share faces structural pressure from INSTI-centered standards.

2) What is the largest driver of real-world performance for rilpivirine regimens?

Dosing with food and adherence behavior, plus drug-drug interaction management that can affect exposure and tolerability.

3) How does resistance risk affect rilpivirine demand?

Virologic failure and prior NNRTI resistance patterns can restrict eligibility and reduce switching in treatment-experienced populations.

4) What clinical evidence would most protect rilpivirine market access?

Data that expands or maintains switch eligibility, supports tolerability and adherence advantages, or strengthens guideline recommendations in defined patient subsets.

5) What is the primary valuation risk?

Share compression and net price erosion as INSTI-based regimens capture greater treatment and switch volumes.

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References

[1] World Health Organization. Guidelines for the treatment of persons with human immunodeficiency virus: 2023 recommendations. WHO, 2023.