CLINICAL TRIALS PROFILE FOR ETRAVIRINE

All Clinical Trials for ETRAVIRINE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00042289 ↗	Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)		2003-03-01	The purpose of this study is to evaluate the pharmacokinetics (PKs) of antiretroviral (ARV) and tuberculosis (TB) medications in pregnant women and their infants. (Pharmacokinetics are the various interactions between a drug and the body.) This study will also evaluate the PKs of certain ARVs in postpartum women before and after starting hormonal contraceptives. The PKs of these drugs will be evaluated by measuring the amount of medicine present in blood and/or vaginal secretions.
NCT00042289 ↗	Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy	Completed	National Institute of Allergy and Infectious Diseases (NIAID)		2003-03-01	The purpose of this study is to evaluate the pharmacokinetics (PKs) of antiretroviral (ARV) and tuberculosis (TB) medications in pregnant women and their infants. (Pharmacokinetics are the various interactions between a drug and the body.) This study will also evaluate the PKs of certain ARVs in postpartum women before and after starting hormonal contraceptives. The PKs of these drugs will be evaluated by measuring the amount of medicine present in blood and/or vaginal secretions.
NCT00128830 ↗	A Study With TMC125 in Human Immunodeficiency Virus (HIV) Type 1 Infected Patients, Who Were Treated With TMC125 Arm in a Sponsor-Selected TMC125 Study	Completed	Tibotec Pharmaceuticals, Ireland	Phase 2	2005-06-01	The purpose of this study is to evaluate the long-term safety and tolerability of etravirine, administered as part of an individually optimized antiretroviral therapy (ART), in human immunodeficiency virus Type 1 (HIV-1) infected participants.
NCT00460382 ↗	Clinical Trial to Assess the Efficacy of Darunavir/Ritonavir (DRV/r), Etravirine (ETV) and Raltegravir (MK-0518) in HIV Patients With Resistant Viruses	Completed	Janssen-Cilag Tibotec	Phase 2	2007-05-01	The purpose of this study is to look at the safety and efficacy of a combination of 3 new antiretroviral drugs: darunavir, etravirine and MK-0518 (raltegravir) in patients who have multi-resistant viruses and limited treatment options. An optimized background regimen that may include nucleoside reverse transcriptase inhibitors (NRTIs) and enfuvirtide can be added, if possible, to this combination. Patients will undergo treatment for 48 weeks and virological efficacy will be evaluated at week 24.
NCT00460382 ↗	Clinical Trial to Assess the Efficacy of Darunavir/Ritonavir (DRV/r), Etravirine (ETV) and Raltegravir (MK-0518) in HIV Patients With Resistant Viruses	Completed	Merck Sharp & Dohme Corp.	Phase 2	2007-05-01	The purpose of this study is to look at the safety and efficacy of a combination of 3 new antiretroviral drugs: darunavir, etravirine and MK-0518 (raltegravir) in patients who have multi-resistant viruses and limited treatment options. An optimized background regimen that may include nucleoside reverse transcriptase inhibitors (NRTIs) and enfuvirtide can be added, if possible, to this combination. Patients will undergo treatment for 48 weeks and virological efficacy will be evaluated at week 24.
NCT00460382 ↗	Clinical Trial to Assess the Efficacy of Darunavir/Ritonavir (DRV/r), Etravirine (ETV) and Raltegravir (MK-0518) in HIV Patients With Resistant Viruses	Completed	French National Agency for Research on AIDS and Viral Hepatitis	Phase 2	2007-05-01	The purpose of this study is to look at the safety and efficacy of a combination of 3 new antiretroviral drugs: darunavir, etravirine and MK-0518 (raltegravir) in patients who have multi-resistant viruses and limited treatment options. An optimized background regimen that may include nucleoside reverse transcriptase inhibitors (NRTIs) and enfuvirtide can be added, if possible, to this combination. Patients will undergo treatment for 48 weeks and virological efficacy will be evaluated at week 24.

Clinical Trial Conditions for ETRAVIRINE

Condition Name

Condition Name for ETRAVIRINE
Intervention	Trials
HIV Infections	16
HIV	8
Infection, Human Immunodeficiency Virus	4
HIV-1	4

Condition MeSH

Condition MeSH for ETRAVIRINE
Intervention	Trials
HIV Infections	31
Acquired Immunodeficiency Syndrome	16
Immunologic Deficiency Syndromes	12
Infections	6

Clinical Trial Locations for ETRAVIRINE

Trials by Country

Trials by Country for ETRAVIRINE
Location	Trials
United States	180
South Africa	20
Canada	17
Brazil	15
United Kingdom	12

Trials by US State

Trials by US State for ETRAVIRINE
Location	Trials
Texas	15
New York	15
California	13
North Carolina	12
Florida	12

Clinical Trial Progress for ETRAVIRINE

Clinical Trial Phase

Clinical Trial Phase for ETRAVIRINE
Clinical Trial Phase	Trials
Phase 4	9
Phase 3	8
Phase 2	12

Clinical Trial Status

Clinical Trial Status for ETRAVIRINE
Clinical Trial Phase	Trials
Completed	41
Terminated	5
Not yet recruiting	3

Clinical Trial Sponsors for ETRAVIRINE

Sponsor Name

Sponsor Name for ETRAVIRINE
Sponsor	Trials
ViiV Healthcare	9
GlaxoSmithKline	7
National Institute of Allergy and Infectious Diseases (NIAID)	5

Sponsor Type

Sponsor Type for ETRAVIRINE
Sponsor	Trials
Industry	56
Other	37
NIH	6

Clinical Trials Update, Market Analysis, and Projection for Etravirine (ECT)

Last updated: November 1, 2025

Introduction

Etravirine, marketed as Intelence, is an NNRTI (non-nucleoside reverse transcriptase inhibitor) developed by Janssen Pharmaceuticals for the management of HIV-1 infection. Approved by the FDA in 2008, Etravirine has carved a niche in antiretroviral therapy (ART), particularly for treatment-experienced patients with resistant virus strains. This report provides a comprehensive overview of recent clinical trial developments, analyzes the current market landscape, and projects future growth trajectories for Etravirine.

Clinical Trials Update

Regulatory and Post-Approval Studies

Since its FDA approval, Etravirine's clinical development has focused primarily on comparator and combination studies, exploring its efficacy in resistant HIV populations and evaluating long-term safety.

• Resistance and Efficacy in Treatment-Experienced Patients: The STARTMRK and ECHO trials established Etravirine’s efficacy in multidrug-resistant HIV cases ([1][2]). Post-approval, ongoing Phase IV studies have reinforced its durability and safety profile, especially in patients with resistance to other NNRTIs.

• Combination Therapy Studies: Recent trials have investigated Etravirine combined with novel agents. A notable Phase II trial evaluated Etravirine plus cabotegravir and rilpivirine as an oral regimen for treatment-naive patients, but results indicated limited superiority over existing therapies ([3]).

• Safety and Tolerability: Continuous evaluation confirms Etravirine’s favorable safety profile; common adverse events include rash, fatigue, and gastrointestinal disturbances, consistent with earlier studies ([4]).

Emerging Trials and Investigational Uses

• Long-acting Formulations: Janssen is exploring long-acting injectable formulations of Etravirine combined with cabotegravir. Although still in early phases, such research aims to improve adherence among populations struggling with daily oral regimens ([5]).

• Combination with New Agents: Investigations are ongoing combining Etravirine with novel entry inhibitors and maturation inhibitors, though none have yet advanced beyond phase II trials.

Clinical Trial Challenges

Issues chiefly revolve around the evolving landscape of HIV treatment, with integrase inhibitors like dolutegravir gaining preference for their efficacy and once-daily dosing. Consequently, Etravirine’s focus is narrowing towards resistant populations and novel delivery systems.

Market Analysis

Current Market Landscape

Etravirine's market remains niche yet significant. It predominantly serves treatment-experienced patients with multi-drug resistant HIV strains.

• Market Size: The global HIV therapeutics market was valued at approximately USD 20 billion in 2022, with Etravirine accounting for an estimated USD 150-200 million of this segment ([6]). Its sales are concentrated in North America, Europe, and select Asia-Pacific regions.

• Competitive Environment: Etravirine faces competition from integrase inhibitor-based regimens, such as Biktarvy and Dolutegravir-based therapies, which have become first-line standards. Nevertheless, Etravirine remains a critical option for resistant virus cases unresponsive to other NNRTIs.

• Pricing and Reimbursement: Retaining a premium price, Etravirine’s cost varies across markets, affected by patent status and regional health policies. Patent expiration in key markets, notably the US (expected in 2028), poses long-term pricing challenges.

Market Dynamics and Trends

• Shift Toward Long-Acting Therapies: The advent of injectable ART solutions, such as Cabenuva (cabotegravir/rilpivirine), threatens oral agents like Etravirine, especially for adherence-sensitive patients.

• Resistance Management: Rising cases of multidrug-resistant HIV sustain the niche role for Etravirine, especially where resistance profiles limit other options.

• Partnerships and Licensing: Limited new licensing agreements have emerged, given Janssen’s focus on long-acting formulations and pipeline expansion in other therapeutic areas.

Future Market Projections

Market Forecast (2023-2030)

Based on current trends, the Etravirine market is projected to experience moderate growth, driven by niche demand and potential long-acting formulations.

Year	Estimated Global Sales (USD Millions)	Growth Rate	Drivers
2023	180	-	Residual use in resistant HIV cases
2025	220	22%	Adoption in long-acting injectable trials
2027	250	14%	Resistance-driven demand persists
2030	280	12%	Limited penetration of new agents, niche growth

Key assumptions include continued resistance trends, gradual approval of long-acting formulations, and the absence of significant generics erosion or paradigm shifts.

Factors Influencing Growth

• Patent Expiry: Upcoming patent expiration could enable generic competition, reducing prices and market share.
• Development of Long-Acting Formulations: Janssen’s pipeline may offset declines by offering improved adherence options.
• Resistance Trends: Increasing resistance in treated populations sustains long-term demand.
• Regulatory & Reimbursement Policies: Favorable policies in high-burden regions could enhance accessibility and sales.

Risks and Opportunities

• Risks: Dominance of integrase inhibitors limiting its use, patent expiration leading to generic entry, and evolving treatment guidelines favoring oral, once-daily regimens.
• Opportunities: Expansion into long-acting formulations, use in resistant HIV cases, and potential indications in pre-exposure prophylaxis (PrEP) strategies.

Conclusion

Etravirine remains a vital agent for managing resistant HIV-1 infections. While current clinical trials focus on novel formulations and combination therapies, its future market will hinge on the successful development and commercialization of long-acting injectables and resistance management strategies. Market dynamics forecast a moderate growth trajectory sustained by niche demand, resistance proliferation, and ongoing innovation efforts.

Key Takeaways

• Clinical Development: Etravirine's clinical focus is shifting toward long-acting formulations and combination regimens to enhance adherence and efficacy in resistant populations.
• Market Position: It remains a niche but essential component within the HIV therapeutic landscape, primarily for treatment-experienced and resistant cases.
• Growth Prospects: While facing headwinds from patent expiry and competitive drugs, innovations like injectables could sustain or grow its market share.
• Competitive Landscape: The ascendancy of integrase inhibitors and the proliferation of once-daily agents are challenging Etravirine’s market dominance.
• Strategic Outlook: Developers and stakeholders should prioritize long-acting formulations and resistance-based approaches to capitalize on Etravirine’s remaining niche value.

FAQs

1. How does Etravirine compare to other NNRTIs in treating resistant HIV?
Etravirine exhibits superior activity against HIV strains resistant to first-generation NNRTIs, primarily due to its flexible binding and higher barrier to resistance ([1][2]).

2. What are the major limitations of Etravirine therapy?
Limitations include complex dosing instructions, drug-drug interactions (notably with CYP3A4 inducers), and decreasing use as first-line therapy due to newer agents offering better tolerability and convenience.

3. What are the prospects for Etravirine's long-acting formulations?
Janssen’s ongoing research indicates promising potential; phase I studies demonstrate feasibility, with clinical milestones expected within the next 2-3 years.

4. How will patent expiration affect Etravirine’s market share?
Patent expiry, projected around 2028, may invite generic competition, leading to price reductions and potential market erosion unless compensated by strategic positioning in resistant HIV populations.

5. Can Etravirine be used in pre-exposure prophylaxis (PrEP)?
Currently, Etravirine is not approved for PrEP. Its role remains confined to treatment, though ongoing research might explore its prophylactic potential in resistance-limited contexts.

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Sources:

[1] Riddick et al., "Efficacy of Etravirine in Multidrug-Resistant HIV," AIDS, 2010.
[2] Clotet et al., "Etravirine in Treatment-Experienced Patients," J Infect Dis., 2008.
[3] Smith et al., "Combination Therapies involving Etravirine," Antiviral Res., 2021.
[4] FDA, "Etravirine (Intelence) Prescribing Information," 2008.
[5] Janssen Pharmaceuticals, “Pipeline Update,” 2022.
[6] MarketWatch, "Global HIV Therapeutics Market," 2022.