CLINICAL TRIALS PROFILE FOR EDURANT

All Clinical Trials for EDURANT

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
NCT01467531 ↗	A Study to Evaluate the Pharmacokinetics and Safety of GSK1265744 and Rilpivirine and Dolutegravir and Rilpivirine in Healthy Adult Subjects	Completed	Shionogi	Phase 1	2011-11-01	This will be a single-center, two-cohort, three-period study in healthy adult subjects. Approximately 16 healthy subjects will be enrolled in Cohort 1 to provide data from 14 evaluable subjects. Approximately 12 healthy subjects will be enrolled in Cohort 2 to provide data from 10 evaluable subjects. Subjects will have a screening visit within 30 days prior to the first dose of study drug, three treatment periods, and a follow-up visit 7-14 days after the last dose of study drug. There will be a washout period between Period 1 and Period 2 but no washout between Period 2 and Period 3. Day 1 of Period 3 will start the day after the last day in Period 2. The study will be conducted on an out-patient basis except for days where serial pharmacokinetic sampling and safety assessments are scheduled.
NCT01467531 ↗	A Study to Evaluate the Pharmacokinetics and Safety of GSK1265744 and Rilpivirine and Dolutegravir and Rilpivirine in Healthy Adult Subjects	Completed	ViiV Healthcare	Phase 1	2011-11-01	This will be a single-center, two-cohort, three-period study in healthy adult subjects. Approximately 16 healthy subjects will be enrolled in Cohort 1 to provide data from 14 evaluable subjects. Approximately 12 healthy subjects will be enrolled in Cohort 2 to provide data from 10 evaluable subjects. Subjects will have a screening visit within 30 days prior to the first dose of study drug, three treatment periods, and a follow-up visit 7-14 days after the last dose of study drug. There will be a washout period between Period 1 and Period 2 but no washout between Period 2 and Period 3. Day 1 of Period 3 will start the day after the last day in Period 2. The study will be conducted on an out-patient basis except for days where serial pharmacokinetic sampling and safety assessments are scheduled.

Clinical Trial Conditions for EDURANT

Condition Name

Condition Name for EDURANT
Intervention	Trials
HIV	3
HIV Infections	2
Contraception	2

Condition MeSH

Condition MeSH for EDURANT
Intervention	Trials
HIV Infections	6
Immunologic Deficiency Syndromes	4
Acquired Immunodeficiency Syndrome	4

Clinical Trial Locations for EDURANT

Trials by Country

Trials by Country for EDURANT
Location	Trials
United States	14
Uganda	3
Thailand	2
South Africa	2
Spain	1

Trials by US State

Trials by US State for EDURANT
Location	Trials
New York	2
North Dakota	1
Washington	1
Texas	1
Tennessee	1

Clinical Trial Progress for EDURANT

Clinical Trial Phase

Clinical Trial Phase for EDURANT
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	2
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for EDURANT
Clinical Trial Phase	Trials
Completed	6
Unknown status	4
Recruiting	2

Clinical Trial Sponsors for EDURANT

Sponsor Name

Sponsor Name for EDURANT
Sponsor	Trials
ViiV Healthcare	2
University of Liverpool	2
University of Nebraska	2

Sponsor Type

Sponsor Type for EDURANT
Sponsor	Trials
Other	14
Industry	10
NIH	1

Last updated: April 30, 2026

Edurant (rilpivirine): What’s the latest on clinical trials and how does the market project through loss-of-exclusivity risk?

What is Edurant and where does it sit in HIV treatment?

Edurant is the brand name for rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI) used in combination antiretroviral therapy for HIV-1 infection. The product is marketed as once-daily oral rilpivirine and is used in multiple regimen constructs (including fixed-dose and combination approaches in the wider rilpivirine ecosystem).

From a patent strategy perspective, Edurant is no longer early in its lifecycle; the relevant business question is market durability versus generic erosion and any remaining proprietary line extensions (formulation, dosing, indication expansions, or combination products).

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What clinical-trials updates exist for Edurant (rilpivirine)?

Edurant’s latest “signal” for ongoing clinical activity generally comes from:

• long-term follow-up studies in existing cohorts,
• real-world evidence and regimen optimization studies,
• post-approval studies, often focused on safety, tolerability, adherence, drug-drug interactions, or resistance outcomes in specific populations.

However, producing a complete and accurate “latest clinical trials update” requires identifying the current set of actively recruiting, not-yet-completed, and recently completed trials for rilpivirine/Edurant, including dates, endpoints, sample sizes, and results status. That dataset is not available in the provided material, so an accuracy-guaranteed update cannot be produced.

No clinical-trials names, NCT numbers, enrollment timelines, or results dates are included in the prompt. Under the operating constraint, an incomplete clinical-trials summary would be incorrect.

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What is the current market reality for rilpivirine/Edurant?

Edurant’s market is driven by:

• the share of patients on NNRTI-based regimens,
• regimen preference across guideline-aligned therapy lines,
• durability versus competing NNRTIs and integrase inhibitor-based regimens,
• generic penetration for rilpivirine products and fixed-dose combinations.

In late-stage HIV markets, branded NNRTI franchises often face margin compression after generic entry and increased physician preference for integrase inhibitor-based single-tablet regimens. For Edurant specifically, the key business logic is:

1. Volume pressure: generic rilpivirine reduces branded pricing power.
2. Switching dynamics: physicians move patients based on tolerability, viral suppression stability, resistance history, and pill burden.
3. Residual brand pockets: adherence, cohort stability, and formulary placement in certain health systems can keep branded usage alive, but not indefinitely.

A full market analysis requires country-level sales trajectories, share trends by regimen type, pricing and reimbursement changes, and the timing of generic launches. That market dataset is not provided.

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How should projections be built: what drives downside and upside for Edurant?

A defensible projection model for Edurant must tie to:

• generic entry timing by geography,
• formulary dynamics and reimbursement status,
• competition from newer classes and NNRTI rivals,
• patient cohort behavior (switch rates after suppression, resistance-driven eligibility).

Without sales history and launch dates, any numeric projection would be fabricated. The constraint requires producing nothing when sufficient information is not available for a complete and accurate response.

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Key Takeaways

• Edurant is rilpivirine (NNRTI) used in combination ART for HIV-1 infection.
• A complete, accurate “clinical trials update” requires the current roster of rilpivirine/Edurant studies with NCT identifiers, status, dates, and outcomes; that information is not present.
• A complete, accurate “market analysis and projection” requires sales and market-structure inputs (sales by geography, generic launch dates, pricing, formulary dynamics); those inputs are not present.
• Under these constraints, no numeric projections or “latest trials” claims can be produced without risking inaccuracy.

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FAQs

1) Is Edurant still being studied in new clinical trials?

Edurant/rilpivirine continues to appear in post-approval research, but a current status update cannot be provided here without the trial-level dataset.

2) What’s the biggest commercial risk for Edurant?

Generic penetration and formulary displacement driven by class competition and pricing pressure.

3) What endpoints matter most in rilpivirine trials?

Viral suppression durability (HIV-1 RNA), resistance emergence, safety and tolerability, and treatment-switch or discontinuation rates.

4) Does rilpivirine have clear differentiation versus integrase inhibitors?

Rilpivirine’s positioning depends on regimen fit, tolerability, and patient-specific resistance and prior therapy history; differentiation is largely cohort and guideline-driven.

5) Can Edurant projections be made without sales and launch timing data?

No. Reliable projections require historical sales trajectories and the timing of patent/generic milestones by geography.

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References

No sources were provided in the prompt, and no external sources can be cited without access to a verifiable dataset.