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.

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
Florida	12
North Carolina	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

Etravirine: clinical-trials update, market analysis, and projections

Last updated: May 1, 2026

What is etravirine and what is the current clinical posture?

Etravirine is an oral HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI). In clinical practice it is used in treatment-experienced adults and adolescents with resistance to other antiretrovirals, typically in combination regimens.

Clinical-trials update (2020 to present):

• The product is long-established and is largely in the late-life / post-approval phase rather than a pipeline growth driver.
• Across recent years, trial activity has shifted toward:
  • Long-term safety and real-world evidence follow-on studies
  • Pharmacokinetic and formulation comparisons (e.g., food effects, switching strategies)
  • Operational studies tied to HIV guideline updates and program delivery
• Net effect: new pivotal efficacy trials are limited relative to newer NNRTIs and integrase inhibitor regimens, which dominate contemporary first-line and much of second-line strategy.

Regulatory label positioning (high level):

• Etravirine remains a resistance-optimized option inside combination therapy for patients with prior NNRTI exposure and resistance patterns, where maintaining viral suppression depends on preserving activity from the remaining active agents in the regimen.

How does etravirine fit the competitive landscape?

Etravirine competes primarily against other agents in the same therapeutic space and treatment-lines:

Competitive substitution pressures

• Next-generation NNRTIs with higher resistance barriers and better tolerability profiles have reduced the marginal need for etravirine in some populations.
• Integrase inhibitors (INSTIs) now anchor most modern regimens, lowering the probability that etravirine becomes the sole driver for regimen selection.
• In treatment-experienced settings, etravirine is still used when resistance and prior exposure patterns preserve its utility.

Main competitive cohorts

• NNRTIs: other established NNRTIs and newer agents depending on region and guideline.
• INSTIs: broadly used across lines of therapy and often preferred for regimen simplification and durability.
• Protease inhibitors and entry inhibitors: selected based on resistance and regimen construction constraints.

What is the market outlook for etravirine?

Market performance for mature antiretrovirals tends to follow four forces: access, guideline adherence, resistance-era prescribing, and generic competition.

Market structure

Etravirine is a mature, widely available antiretroviral, so pricing and volume are heavily shaped by:

• Generic entry and tender dynamics in major public procurement markets
• Health system formularies that prefer the newest classes where cost permits
• Resistance-informed prescribing that sustains demand for older options in treatment-experienced populations

Demand drivers

• Treatment-experienced patient volumes: patients on failing regimens or requiring regimen switches due to resistance maintain a residual demand pool.
• Resistance-preserving regimen design: in patients with specific NNRTI resistance profiles, etravirine can still be one of the usable NNRTIs.

Demand headwinds

• Switching to INSTI-based regimens where feasible, reducing NNRTI-centered regimen selection.
• Guideline evolution that often places newer agents ahead of etravirine in algorithmic sequencing.
• Procurement substitution: payer and program switches after generic price resets for alternative class members.

Clinical-trials update: what evidence is typically being generated now?

For late-stage commercial products like etravirine, trial activity usually consolidates understanding rather than redefining indications. The evidence typically targets:

• Long-term safety in routine regimen use
• Pharmacokinetics under co-medications and special populations
• Adherence and switching strategy outcomes in real-world settings
• Formulation performance under standard administration conditions

Market projection: base, bull, and bear paths

Because etravirine is mature and subject to generic substitution, the projection profile is typically shaped by unit price erosion plus limited volume growth.

Projection logic (scenario framework)

Scenario	Pricing / procurement	Guideline positioning	Net market trajectory
Bear	Faster generic price compression	Continued shift to INSTI-centered regimens	Declining global value faster than volume
Base	Steady tender-based pricing	Sustained use in resistance-defined subgroups	Flat-to-slow decline in value; modest volume stability
Bull	Slower procurement compression	Broader persistence in treatment-experienced NNRTI use	Value declines slower; volume stable-to-slightly positive

Where value concentrates

• Public procurement regions with large treatment-experienced cohorts
• Countries where NNRTI options remain in formularies for resistance-aware prescribing

Where demand concentrates less

• Settings that have moved aggressively toward regimens that reduce reliance on NNRTIs in second-line and beyond

Commercial implications for R&D and investment decisions

Etravirine does not represent a “pipeline risk” asset in the same way as novel entrants. The business question is whether it still produces:

• Near-term cash flow consistent with mature generic economics, and
• Strategic value as part of portfolio coverage for resistance-based HIV care.

Actionable takeaways for strategy

• Treat etravirine as a portfolio stabilizer tied to treatment-experienced resistance niches rather than a growth engine.
• Competitive dynamics are driven more by procurement pricing and regimen guidelines than by new clinical endpoints.

Key Takeaways

• Etravirine is a mature HIV NNRTI with clinical activity centered on post-approval evidence rather than new pivotal efficacy.
• Market demand persists mainly in treatment-experienced, resistance-informed regimens.
• Forecasts skew toward flat-to-declining value, with magnitude determined by generic price compression and ongoing guideline shifts toward INSTI-based strategies.

FAQs

1) Is etravirine still used in first-line HIV therapy?
Typically, etravirine use is more concentrated in treatment-experienced populations where resistance and prior exposure make specific regimen construction necessary.

2) What keeps etravirine demand from collapsing entirely?
Resistance-defined subgroup use and ongoing need to build active combinations in patients with prior NNRTI exposure.

3) What is the biggest market risk for etravirine?
Competitive substitution driven by guideline sequencing and procurement-driven switching, especially toward INSTI-based regimens.

4) What is the most likely clinical-trial direction for mature etravirine?
Long-term safety, pharmacokinetic and co-medication work, and operational real-world evidence rather than new pivotal trials.

5) Does etravirine offer differentiation versus newer NNRTIs?
Differentiation is tied to clinical positioning in patients with resistance patterns that preserve etravirine’s activity, not to broad first-line regimen dominance.

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Cited sources
No citations were included because no verifiable, source-backed clinical-trial-by-trial update or numeric market forecast inputs were provided in the prompt and no source material was supplied for retrieval in this session.