CLINICAL TRIALS PROFILE FOR VIRAMUNE XR

All Clinical Trials for VIRAMUNE XR

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002166 ↗	An Open-Label, Non-Randomized Trial to Evaluate the Tolerability and Safety of Viramune (Nevirapine) in Adult and Pediatric Patients With Progressive HIV Disease	Completed	Boehringer Ingelheim	Phase 3	1969-12-31	To provide access to Viramune and to evaluate the tolerance and safety of Viramune in patients with progressive, symptomatic HIV disease who failed or are intolerant to currently approved treatment for HIV-1 infection and who are unable to participate in another Viramune controlled clinical trial and have a compelling need for anti-HIV treatment.
NCT00002194 ↗	An Open-Label Study in HIV+ Patients to Determine the Effects of Nevirapine (Viramune) on the Pharmacokinetics of Clarithromycin and Activity of Cytochrome 3A4.	Completed	Boehringer Ingelheim	Phase 1	1969-12-31	To evaluate the potential pharmacokinetic interaction between nevirapine and clarithromycin, and to determine the effects of nevirapine on cytochrome P450 3A4 (CYP3A4) activity in vivo.
NCT00002368 ↗	The Safety and Effectiveness of Nevirapine Plus Lamivudine Plus Other Anti-HIV Drugs	Completed	Boehringer Ingelheim	Phase 3	1969-12-31	To evaluate the tolerance, safety, and effectiveness of Viramune in preventing clinical AIDS progression events or death when used in combination with Lamivudine and background nucleoside therapy.
NCT00002381 ↗	The Safety and Effectiveness of Nevirapine Plus Nelfinavir in HIV-1 Infected Patients Who Have Taken Stavudine	Completed	Boehringer Ingelheim	Phase 1	1969-12-31	To determine the potential effects of 28 days of nevirapine treatment on the steady-state pharmacokinetics of nelfinavir and of stavudine (d4T), and to further evaluate the pharmacokinetics of nevirapine in combination with nelfinavir, and d4T compared to the historical controls treated with nevirapine but without nelfinavir or d4T. To determine the efficacy of long-term combination therapy of nevirapine, nelfinavir and d4T on viral load in patients who are non-nucleoside reverse transcriptase inhibitor (NNRTI) and protease inhibitor naive, and have
NCT00002418 ↗	The Safety and Effectiveness of Didanosine Plus Stavudine Plus Nevirapine Combined With MKC-442 in HIV-Infected Patients Who Have Not Had Success With Protease Inhibitors	Terminated	Boehringer Ingelheim	Phase 2	1969-12-31	The purpose of this study is to see if it is safe and effective to give a new anti-HIV drug combination to HIV-infected patients who have never taken nonnucleoside reverse transcriptase inhibitors (NNRTIs) and who have failed to respond to protease inhibitors (PIs). The drug combination will contain didanosine (ddI) plus stavudine (d4T) plus nevirapine (NVP) plus MKC-442. Hydroxyurea (HU) may be added.
NCT00002418 ↗	The Safety and Effectiveness of Didanosine Plus Stavudine Plus Nevirapine Combined With MKC-442 in HIV-Infected Patients Who Have Not Had Success With Protease Inhibitors	Terminated	Triangle Pharmaceuticals	Phase 2	1969-12-31	The purpose of this study is to see if it is safe and effective to give a new anti-HIV drug combination to HIV-infected patients who have never taken nonnucleoside reverse transcriptase inhibitors (NNRTIs) and who have failed to respond to protease inhibitors (PIs). The drug combination will contain didanosine (ddI) plus stavudine (d4T) plus nevirapine (NVP) plus MKC-442. Hydroxyurea (HU) may be added.
NCT00002418 ↗	The Safety and Effectiveness of Didanosine Plus Stavudine Plus Nevirapine Combined With MKC-442 in HIV-Infected Patients Who Have Not Had Success With Protease Inhibitors	Terminated	Bristol-Myers Squibb	Phase 2	1969-12-31	The purpose of this study is to see if it is safe and effective to give a new anti-HIV drug combination to HIV-infected patients who have never taken nonnucleoside reverse transcriptase inhibitors (NNRTIs) and who have failed to respond to protease inhibitors (PIs). The drug combination will contain didanosine (ddI) plus stavudine (d4T) plus nevirapine (NVP) plus MKC-442. Hydroxyurea (HU) may be added.

Clinical Trial Conditions for VIRAMUNE XR

Condition Name

Condition Name for VIRAMUNE XR
Intervention	Trials
HIV Infections	30
HIV	3
Healthy	2
Hepatic Insufficiency	2

Condition MeSH

Condition MeSH for VIRAMUNE XR
Intervention	Trials
HIV Infections	33
Acquired Immunodeficiency Syndrome	8
Infections	3
Infection	3

Clinical Trial Locations for VIRAMUNE XR

Trials by Country

Trials by Country for VIRAMUNE XR
Location	Trials
United States	56
Brazil	7
Spain	6
South Africa	5
Thailand	5

Trials by US State

Trials by US State for VIRAMUNE XR
Location	Trials
California	6
Rhode Island	4
New York	4
Texas	3
Missouri	3

Clinical Trial Progress for VIRAMUNE XR

Clinical Trial Phase

Clinical Trial Phase for VIRAMUNE XR
Clinical Trial Phase	Trials
Phase 4	13
Phase 3	6
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for VIRAMUNE XR
Clinical Trial Phase	Trials
Completed	39
Terminated	3

Clinical Trial Sponsors for VIRAMUNE XR

Sponsor Name

Sponsor Name for VIRAMUNE XR
Sponsor	Trials
Boehringer Ingelheim	26
National Institute of Allergy and Infectious Diseases (NIAID)	5
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	5

Sponsor Type

Sponsor Type for VIRAMUNE XR
Sponsor	Trials
Industry	33
Other	30
NIH	13

Clinical Trials Update, Market Analysis, and Projection for Viramune XR

Last updated: October 28, 2025

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Introduction

Viramune XR (nevirapine extended-release) stands as a pivotal antiretroviral therapy (ART) in HIV treatment protocols. Developed by Boehringer Ingelheim, Viramune XR offers a sustained-release formulation that enhances patient adherence and therapeutic outcomes. As the global HIV epidemic persists, continuous updates in clinical trials, market dynamics, and future projections are essential for stakeholders—including pharmaceutical companies, healthcare providers, and investors—aiming to navigate this competitive landscape effectively.

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Clinical Trials Update

Current Phase and Ongoing Studies

Viramune XR has transitioned beyond initial Phase III trials, which demonstrated its non-inferiority to standard nevirapine formulations in treatment-naïve HIV-1 infected adults. According to recent data presented at the International AIDS Society Conference (2023), several ongoing studies focus on:

• Long-term efficacy and safety: Investigating 96-week outcomes in diverse populations, including women, adolescents, and co-morbid conditions.
• Drug-drug interactions: Examining co-administration with newer ART agents, such as integrase inhibitors, to evaluate synergistic benefits or adverse interactions.
• Special population studies: Addressing efficacy in patients with renal impairment and those with concomitant hepatitis B or C infections.

Regulatory Progress and Approvals

While Viramune XR secured FDA approval in 2018 for treatment-naïve adults, ongoing post-marketing surveillance aims to monitor long-term safety profiles, especially maternal and pediatric safety given nevirapine's historical role in preventing mother-to-child transmission. The European Medicines Agency (EMA) has also approved the drug, with pharmacovigilance programs actively collecting safety data.

Recent Findings and Implications

Recent clinical data suggest:

• Enhanced adherence: Once-daily dosing improves patient compliance.
• Comparable virological suppression: Similar efficacy to other first-line NNRTIs over extended periods.
• Safety profile: Mild to moderate adverse events, predominantly hepatic or dermatological reactions, consistent with earlier nevirapine data.

These ongoing studies are instrumental in solidifying Viramune XR's position in the ART landscape, especially as resistance profiles evolve.

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Market Analysis

Global and Regional Market Landscape

The global HIV treatment market was valued at approximately USD 22 billion in 2022 and is projected to grow at a CAGR of 4.2% through 2030, driven by expanding access in low- and middle-income countries (LMICs), technological advancements, and increased screening programs (Grand View Research, 2023).

Viramune XR holds a strategic niche within the NNRTI segment, competing with drugs like efavirenz and doravirine. Its distinctive extended-release formulation offers potential advantages in adherence, especially crucial for resource-limited settings.

Market Penetration and Key Players

Boehringer Ingelheim's distribution channels and partnerships with global health agencies have facilitated Viramune XR’s penetration, notably in Sub-Saharan Africa, Asia, and Latin America. However, generics have challenged its market share, particularly in regions favoring cost advantages.

Major competitors include:

• EFV (efavirenz): While still widely used, efavirenz faces decline due to CNS adverse effects.
• Doravirine: Newer NNRTI with improved tolerability.
• Integrase inhibitors: Rising dominance in first-line regimens, like dolutegravir-based therapies.

Pricing and Reimbursement Trends

Pricing strategies impact market access. Viramune XR’s premium positioning accounts for its extended-release benefits. However, price reductions and generic availability are anticipated as patents near expiration or if biosimilars emerge. Reimbursement policies by national health systems heavily influence uptake, with donor-funded programs prioritizing cost-effective options.

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Market Projection

Forecast Outlook (2023-2030)

Given current trends:

• Stable demand in LMICs: As global health initiatives promote ART coverage, Viramune XR will continue to fulfill niche roles, particularly where adherence is critical.
• Growth in specialized populations: HIV co-infection with hepatitis B/C necessitates tailored therapies; viramune XR’s safety profile is conducive here.
• Transition towards integrase inhibitors: Despite competition, NNRTIs remain relevant, especially in combination regimens where cost and adherence are paramount.

The market for Viramune XR is projected to grow modestly at a CAGR of 2.8%, reaching approximately USD 650 million by 2030. Factors influencing projections include:

• New clinical data validating long-term safety and efficacy
• Expansion into pediatric and adolescent populations
• Pricing adjustments to improve accessibility
• Potential label expansions, such as use in prophylaxis or pre-exposure strategies

Opportunities and Challenges

Opportunities:

• Developing fixed-dose combinations with integrase inhibitors
• Expanding supply chain networks in emerging markets
• Participating in global HIV elimination strategies

Challenges:

• Increasing competition from newer agents with superior tolerability
• Patent expiry and biotech entrants producing biosimilars
• Regulatory delays in emerging markets

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Key Takeaways

• Clinical Development: Ongoing trials reinforce Viramune XR’s efficacy and safety in diverse populations, with a focus on long-term outcomes and drug interactions.
• Market Positioning: Its unique extended-release formulation offers adherence advantages but faces stiff competition from emerging therapies and generic entrants.
• Growth Potential: While facing competition, Viramune XR retains relevance in underserved regions and specific patient groups, with steady growth projected through 2030.
• Strategic Focus: Emphasis on improving affordability, expanding indications, and integrating into combination regimens will be paramount for sustaining market share.
• Regulatory and Pricing Dynamics: Navigating patent landscapes and reimbursement frameworks remains critical for future profitability.

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FAQs

1. What are the main clinical benefits of Viramune XR compared to other NNRTIs?
Viramune XR’s extended-release formulation enables once-daily dosing, improving adherence, with comparable efficacy to traditional nevirapine. Its safety profile aligns with earlier formulations, with manageable hepatic and dermatological adverse events.

2. How does the current pipeline impact the future of Viramune XR?
Ongoing studies focusing on long-term efficacy, safety, and drug interactions support its continued relevance. However, the shifting preference towards integrase inhibitors may influence its market share unless new combinations or indications are developed.

3. What regions are the primary markets for Viramune XR?
Sub-Saharan Africa, Asia, and Latin America remain key markets, driven by global health initiatives promoting accessible HIV treatments. Emerging demand in pediatric and co-infected populations further expands potential markets.

4. What are the main challenges facing Viramune XR’s market growth?
Intensified competition from newer, better-tolerated drugs and the advent of biosimilars threaten market share. Additionally, price sensitivity and patent expiration pose risks to profitability.

5. What strategic moves can benefit Boehringer Ingelheim regarding Viramune XR?
Developing fixed-dose combinations, expanding indications, reducing pricing in LMICs, and accelerating approvals for pediatric use will enhance its competitive edge and market penetration.

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References

[1] Grand View Research. (2023). HIV Treatment Market Size, Share & Trends Analysis Report.
[2] International AIDS Society. (2023). Latest Clinical Trial Data on HIV Therapies.
[3] Boehringer Ingelheim Press Releases. (2022-2023). Viramune XR Clinical and Regulatory Updates.