CLINICAL TRIALS PROFILE FOR EDURANT PED

All Clinical Trials for Edurant Ped

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.
NCT01562886 ↗	The Rilpivirine Cerebrospinal-fluid (CSF) Study	Completed	Janssen-Cilag Ltd.	Phase 1	2012-03-01	This is a phase I pharmacokinetic study of HIV positive patients stable on antiretroviral therapy who will switch treatment when enrolled from nevirapine to rilpivirine. On day 60 of the study the participants will attend clinic where they will have blood collected followed by a lumbar puncture where cerebrospinal fluid will be collected to measure drug concentration. The participants will then restart their original regime with nevirapine.

Clinical Trial Conditions for Edurant Ped

Condition Name

Condition Name for Edurant Ped
Intervention	Trials
HIV	3
Contraception	2
HIV Infections	2
HIV-1-infection	1

Condition MeSH

Condition MeSH for Edurant Ped
Intervention	Trials
HIV Infections	6
Immunologic Deficiency Syndromes	4
Acquired Immunodeficiency Syndrome	4
Infections	3

Clinical Trial Locations for Edurant Ped

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for Edurant Ped

Clinical Trial Phase

Clinical Trial Phase for Edurant Ped
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	2
Phase 2/Phase 3	1

Clinical Trial Status

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

Clinical Trial Sponsors for Edurant Ped

Sponsor Name

Sponsor Name for Edurant Ped
Sponsor	Trials
ViiV Healthcare	2
University of Liverpool	2
University of Nebraska	2

Sponsor Type

Sponsor Type for Edurant Ped
Sponsor	Trials
Other	14
Industry	10
NIH	1

EDURANT PED: Clinical Trials, Market Analysis, and Projections

Introduction

EDURANT PED, containing the active ingredient rilpivirine, is a non-nucleoside reverse transcriptase inhibitor (NNRTI) used in combination with other antiretroviral agents for the treatment of HIV-1 infection. Here, we will delve into the recent clinical trials, market analysis, and projections for this drug, particularly focusing on its pediatric indications.

Clinical Trials Update

Pediatric Studies

Recent clinical trials have been pivotal in expanding the indication of EDURANT PED for pediatric patients. The Phase 2 PAINT (NCT00799864) and PICTURE (NCT04012931) studies provided crucial data supporting the use of EDURANT PED in children.

• PAINT and PICTURE Studies: These studies demonstrated that EDURANT PED, in combination with other antiretroviral therapies, effectively maintains or suppresses the virus in both treatment-experienced and treatment-naive pediatric patients. The data showed that EDURANT PED is safe and effective for children weighing 10 kg or more, with HIV-1 RNA levels less than or equal to 100,000 copies/mL for treatment-naive children and less than 50 copies/mL for treatment-experienced virologically suppressed children[3][4].

Safety and Efficacy

The clinical trials highlighted several key points regarding the safety and efficacy of EDURANT PED in pediatric patients:

• Depressive Disorders: The incidence of depressive disorders was noted, particularly in pediatric subjects, with 19.4% of subjects experiencing depressive disorders, although most were mild or moderate in severity[1].
• Virologic Failure: More subjects with higher baseline HIV-1 RNA levels (>100,000 copies/mL) experienced virologic failure compared to those with lower baseline levels[3][4].
• Adverse Reactions: Common adverse reactions included gastrointestinal disorders, hepatobiliary disorders, and psychiatric disorders, but most were of mild or moderate intensity[1].

Market Analysis

Current Market Position

EDURANT PED has recently received significant regulatory approvals that are set to expand its market presence:

• FDA Approval: The U.S. FDA approved EDURANT PED for children at least 2 years of age, weighing 14 kg to 25 kg, living with HIV-1. This approval provides a new treatment option for this demographic[4].
• European Commission Approval: The European Commission approved EDURANT for children weighing at least 25 kg, and new 2.5 mg dispersible tablets have been developed for weight-adjusted dosing in children weighing 14 kg to less than 25 kg[5].

Patent and Exclusivity

The patent landscape for EDURANT PED is crucial for understanding its market exclusivity:

• Generic Entry Date: The earliest date for generic entry is estimated to be October 21, 2025, based on the current patent protections. However, this date can be influenced by various factors including patent challenges and generic licensing[2].

Market Demand

The demand for EDURANT PED is expected to increase with the expanded pediatric indications:

• Global HIV Epidemic: The ongoing global HIV epidemic continues to necessitate new and improved treatment options. EDURANT PED fills a critical gap by providing a treatment option for younger children, a demographic that has limited treatment choices[3][4].

Projections

Market Growth

Given the recent approvals and the ongoing need for effective HIV treatments, EDURANT PED is projected to experience significant market growth:

• Expanded Indications: The approval for use in younger children is expected to increase the patient population for EDURANT PED, thereby driving market growth.
• Competitive Landscape: EDURANT PED will compete with other antiretroviral therapies, but its unique dosing options and efficacy in pediatric patients are likely to give it a competitive edge[3][5].

Financial Projections

The financial performance of EDURANT PED is anticipated to be robust:

• Revenue Increase: With the expanded indications and increased patient population, revenue from EDURANT PED is expected to rise.
• Market Share: EDURANT PED is likely to capture a significant share of the pediatric HIV treatment market due to its efficacy and safety profile[3][4].

Key Takeaways

• Clinical Trials: EDURANT PED has shown efficacy and safety in pediatric patients in recent clinical trials.
• Regulatory Approvals: Recent FDA and European Commission approvals have expanded the indication for EDURANT PED to include younger children.
• Market Analysis: The drug is poised for market growth due to its unique position in the pediatric HIV treatment market.
• Patent Landscape: The generic entry date is estimated to be October 21, 2025, but this can be influenced by various factors.
• Financial Projections: Revenue and market share are expected to increase with the expanded indications.

FAQs

What is EDURANT PED used for?

EDURANT PED is used in combination with other antiretroviral agents for the treatment of HIV-1 infection in children weighing at least 14 kg.

What are the recent clinical trials that supported the approval of EDURANT PED?

The Phase 2 PAINT and PICTURE studies provided the data supporting the approval of EDURANT PED for pediatric use.

What are the common adverse reactions associated with EDURANT PED?

Common adverse reactions include depressive disorders, gastrointestinal disorders, hepatobiliary disorders, and psychiatric disorders.

When is the generic entry date for EDURANT PED estimated?

The generic entry date is estimated to be October 21, 2025, based on current patent protections.

What is the significance of the recent FDA and European Commission approvals for EDURANT PED?

These approvals expand the indication of EDURANT PED to include children weighing 14 kg to 25 kg, providing a new treatment option for this demographic.

Sources

1. FDA Label for EDURANT and EDURANT PED - accessdata.fda.gov
2. EDURANT Drug Patent Profile - DrugPatentWatch
3. Janssen Submits Supplemental New Drug Application to U.S. FDA - janssen.com
4. U.S. FDA Approves EDURANT PED for Certain Pediatric Patients Living with HIV-1 - jnj.com
5. European Commission Approves Expanded Use of HIV-1 Therapy EDURANT in Younger Pediatric Patients - jnj.com

Last updated: 2025-01-02