CLINICAL TRIALS PROFILE FOR INTELENCE

All Clinical Trials for INTELENCE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00624195 ↗	Clinical Trial of CNS-targeted HAART (CIT2)	Completed	National Institute of Mental Health (NIMH)	Phase 2/Phase 3	2007-03-01	CIT2 is a strategy for targeting HAART (Highly Active Antiretroviral Therapy) to the CNS (Central Nervous System) in patients with HIV associated neurocognitive impairment (HNCI). The primary goal of this study is to evaluate the effectiveness of CNS-targeted (CNS-T) as compared to non-CNS-targeted (non-CNS-T) HAART in treating HNCI globally and in different domains of functioning known to be affected by HIV. It is hypothesized that participants in the CNS-T arm will have greater improvement in neurocognitive functioning than those in the non-CNS-T arm. The secondary goal of the study is to compare participants assigned to CNS-T and non-CNS-T HAART on measures of CNS and systemic HIV suppression (undetectable CSF and plasma VL). It is also hypothesized that although CSF viral suppression will be more frequent in the CNS-T arm, plasma viral suppression will be similar in the two treatment arms.
NCT00624195 ↗	Clinical Trial of CNS-targeted HAART (CIT2)	Completed	National Institutes of Health (NIH)	Phase 2/Phase 3	2007-03-01	CIT2 is a strategy for targeting HAART (Highly Active Antiretroviral Therapy) to the CNS (Central Nervous System) in patients with HIV associated neurocognitive impairment (HNCI). The primary goal of this study is to evaluate the effectiveness of CNS-targeted (CNS-T) as compared to non-CNS-targeted (non-CNS-T) HAART in treating HNCI globally and in different domains of functioning known to be affected by HIV. It is hypothesized that participants in the CNS-T arm will have greater improvement in neurocognitive functioning than those in the non-CNS-T arm. The secondary goal of the study is to compare participants assigned to CNS-T and non-CNS-T HAART on measures of CNS and systemic HIV suppression (undetectable CSF and plasma VL). It is also hypothesized that although CSF viral suppression will be more frequent in the CNS-T arm, plasma viral suppression will be similar in the two treatment arms.
NCT00624195 ↗	Clinical Trial of CNS-targeted HAART (CIT2)	Completed	University of California, San Diego	Phase 2/Phase 3	2007-03-01	CIT2 is a strategy for targeting HAART (Highly Active Antiretroviral Therapy) to the CNS (Central Nervous System) in patients with HIV associated neurocognitive impairment (HNCI). The primary goal of this study is to evaluate the effectiveness of CNS-targeted (CNS-T) as compared to non-CNS-targeted (non-CNS-T) HAART in treating HNCI globally and in different domains of functioning known to be affected by HIV. It is hypothesized that participants in the CNS-T arm will have greater improvement in neurocognitive functioning than those in the non-CNS-T arm. The secondary goal of the study is to compare participants assigned to CNS-T and non-CNS-T HAART on measures of CNS and systemic HIV suppression (undetectable CSF and plasma VL). It is also hypothesized that although CSF viral suppression will be more frequent in the CNS-T arm, plasma viral suppression will be similar in the two treatment arms.
NCT00855088 ↗	Study in Healthy Males to Measure Darunavir and Etravirine in Blood, Seminal Fluid, and Rectal Tissue	Completed	Tibotec Pharmaceutical Limited	Phase 1	2009-07-01	This study is being conducted to look at how the body handles the drugs darunavir and etravirine. It will measure the amount of darunavir and etravirine in blood, semen, and in the rectum of men. The aim is to understand how much of the drug (taken by mouth) reaches the reproductive and intestinal tracts. It is believed that the presence of this drug in these areas may be beneficial in preventing the AIDS virus (HIV) from being passed from one person to another. The study will take samples of blood, semen and rectal mucosal tissue to measure drug levels. This study will also collect information on side effects.

Clinical Trial Conditions for INTELENCE

Condition Name

Condition Name for INTELENCE
Intervention	Trials
HIV Infections	7
HIV-1 Infection	2
HIV/AIDS	2
Acquired Immune Deficiency Syndrome	1

Condition MeSH

Condition MeSH for INTELENCE
Intervention	Trials
HIV Infections	10
Acquired Immunodeficiency Syndrome	5
Infections	3
Infection	2

Clinical Trial Locations for INTELENCE

Trials by Country

Trials by Country for INTELENCE
Location	Trials
United States	24
South Africa	3
Haiti	2
Peru	2
Brazil	2

Trials by US State

Trials by US State for INTELENCE
Location	Trials
North Carolina	4
New York	3
Texas	2
Maryland	2
California	2

Clinical Trial Progress for INTELENCE

Clinical Trial Phase

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

Clinical Trial Status

Clinical Trial Status for INTELENCE
Clinical Trial Phase	Trials
Completed	11
Terminated	2
Recruiting	1

Clinical Trial Sponsors for INTELENCE

Sponsor Name

Sponsor Name for INTELENCE
Sponsor	Trials
University of North Carolina, Chapel Hill	3
Janssen Pharmaceuticals	3
ViiV Healthcare	2

Sponsor Type

Sponsor Type for INTELENCE
Sponsor	Trials
Industry	17
Other	13
NIH	4

INTELENCE Market Analysis and Financial Projection

Last updated: May 2, 2026

INTELENCE (etravirine): Clinical-trial update, market analysis, and projections

What is INTELENCE and what regimen role does it play?

INTELENCE is etravirine, an antiretroviral agent used in HIV-1 infection. Commercial labeling and clinical use position it as part of combination antiretroviral therapy (cART) for patients requiring treatment with fully active agents in the setting of resistance.

Key positioning (label and standard-of-care use):

• Used in combination with other antiretroviral drugs.
• Placed in regimens designed around genotypic resistance and selection of active agents.
• Historically used in treatment-experienced populations given its non-nucleoside reverse transcriptase inhibitor (NNRTI) class mechanism.

Formulation and key product details (commercial reality drivers):

• Oral tablets (brand).
• Sales are tied to persistent use in resistant, multi-class-treated patients, and to how often etravirine remains among clinicians’ NNRTI options versus alternatives.

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What is the clinical-trials update for etravirine?

No new, widely documented late-stage (Phase 3) or registration-defining trial readouts are present in the public domain at a level that would change market expectations in the near term. INTELENCE’s clinical activity is dominated by:

• Ongoing observational and retrospective data collection,
• Pharmacovigilance and label lifecycle updates,
• Comparative regimen use shaped by evolving first-line and second-line standards.

Regimen and clinical practice implications (what affects near-term development value):

• Modern HIV therapy is increasingly anchored in high-barrier integrase inhibitor-based regimens.
• NNRTI use persists, but choice among NNRTIs changes with resistance patterns, dosing convenience, and drug-drug interaction profiles.
• Etravirine remains relevant where an NNRTI is needed and where resistance patterns make it a viable option.

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What does the market look like for INTELENCE today?

INTELENCE is a mature antiretroviral brand operating in a market that is structurally constrained by:

• High penetration of modern regimens,
• Patent and exclusivity maturity,
• Growth shifting toward fixed-dose combinations and newer classes.

Market structure and demand drivers The practical demand for etravirine is driven by:

1. Treatment-experienced populations with NNRTI-relevant sensitivity or residual NNRTI utility.
2. Region-level access patterns and national formulary choices where older agents remain in active formularies.
3. Resistance management workflows where clinicians select from remaining active drug classes.

Headwinds

• Shift toward first-line integrase inhibitor regimens reduces new patient starts for older NNRTI backbones.
• Generic entry and class competition compress brand economics where etravirine competes with lower-cost options (formulary and procurement pressure).
• Pill burden and co-formulation preferences favor fixed-dose approaches.

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How should investors and planners project INTELENCE demand?

A projection for etravirine is best treated as a decline-and-stabilize profile rather than a growth curve. The near-to-mid term expectation should reflect:

• Existing patient retention,
• Slow net attrition due to regimen switching,
• Margin compression from competitive pricing and generic or alternative NNRTI selection where available.

Base-case projection framework (qualitative to numeric mapping)

Use a three-component model:

1. On-treatment population retention (patients continuing etravirine in stable regimens).
2. Incidence displacement (new starts declining as first-line and many second-line pathways use other classes).
3. Price erosion (procurement and competition reduce net price even if volumes stabilize).

Directional projection (commercial view)

• Volumes: gradual decline with a floor tied to resistant-experience continuity and formularies that keep etravirine available.
• Revenue: decline faster than volume due to net price pressure and contracting formularies.
• Market share: stable in constrained niches, eroding overall share versus newer regimens.

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What are the competitive alternatives that influence INTELENCE substitution?

For forecasting, the relevant substitution set is not “NNRTI broadly,” but the actual regimen choices clinicians and procurement systems favor.

Primary competitor groupings:

• Integrase inhibitors in first-line and increasingly second-line strategies.
• Other NNRTIs and newer NNRTI-analog strategies where formularies support them.
• Multi-class salvage options where resistance patterns make etravirine less preferred.

Impact on demand

• Where treatment paradigms shift toward integrase inhibitors, etravirine sees fewer new starts.
• In salvage, selection depends on resistance test results and regimen feasibility. Etravirine retains a niche if it stays among the few active options.

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What timeline risks exist for INTELENCE?

Key risks are commercial, not scientific:

• Formulary tightening: national and large payer preference moves away from older NNRTI brands.
• Procurement price resets: contracting cycles drive net price down.
• Regimen migration: real-world switching from NNRTI-containing regimens to newer backbones reduces long-run persistence.

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What is the actionable business conclusion for INTELENCE stakeholders?

INTELENCE should be modeled as:

• A cash-flow legacy franchise with steady but shrinking patient base,
• A product whose future is tied to resistance-relevant salvage niches and continued formulary inclusion, not to growth-driven clinical expansion.

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Key Takeaways

• INTELENCE (etravirine) is a mature NNRTI in a market increasingly dominated by modern integrase-based regimens.
• Public clinical activity does not show near-term, registration-defining Phase 3 events that would rebase expectations.
• The commercial model is decline-and-stabilize: volumes soften as new starts shift, while revenue erodes from price pressure and competitive substitution.
• Demand persistence depends on treatment-experienced cohorts, resistance test outcomes, and formulary retention.
• Forecasts should be built on patient retention, incidence displacement, and net price erosion rather than on growth assumptions.

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FAQs

1. Is INTELENCE expected to get new major Phase 3 readouts that change the outlook?
   No widely documented registration-defining Phase 3 updates are present in the public domain that would rebase near-term expectations.

2. What patient population most supports remaining INTELENCE demand?
   Treatment-experienced patients where resistance patterns make etravirine a viable NNRTI option and where clinicians can maintain fully active combination regimens.

3. What is the biggest commercial driver: volume or price?
   Over multiple contracting cycles, price erosion tends to reduce revenue faster than volume due to procurement and substitution.

4. Does modern HIV care reduce INTELENCE new starts?
   Yes. Modern first-line and many second-line regimens reduce the share of patients initiated on older NNRTI backbones.

5. Where does INTELENCE still fit competitively?
   In salvage or regimen optimization settings driven by genotypic resistance where an NNRTI remains useful and etravirine is among the workable options.

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References

[1] FDA. INTELENCE (etravirine) prescribing information. U.S. Food and Drug Administration.
[2] WHO. Guidelines for the use of antiretroviral drugs for treating and preventing HIV infection. World Health Organization.
[3] IAS-USA. International Antiviral Society-USA guidelines for the use of antiretroviral agents in adults and adolescents with HIV. International Antiviral Society.