CLINICAL TRIALS PROFILE FOR ISENTRESS

All Clinical Trials for Isentress

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00485264 ↗	Safety and Pharmacokinetics (PK) of Raltegravir in HIV (Human Immunodeficiency Virus)-Infected Children and Adolescents	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 1/Phase 2	2007-09-17	Integrase is 1 of 3 HIV (Human Immunodeficiency Virus)-1 enzymes required for viral replication. Raltegravir is a drug that prevents integrase from working properly. This drug has been tested for safety and efficacy in adults, but this is the first study to examine raltegravir in children and adolescents. The purpose of this study was to determine the appropriate dose for raltegravir across the pediatric age range from 4 weeks to 18 years of age, by acquiring short and long term safety data, intensive and population pharmacokinetic (PK) data, and efficacy experience with raltegravir in HIV-infected children and adolescents.
NCT00485264 ↗	Safety and Pharmacokinetics (PK) of Raltegravir in HIV (Human Immunodeficiency Virus)-Infected Children and Adolescents	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1/Phase 2	2007-09-17	Integrase is 1 of 3 HIV (Human Immunodeficiency Virus)-1 enzymes required for viral replication. Raltegravir is a drug that prevents integrase from working properly. This drug has been tested for safety and efficacy in adults, but this is the first study to examine raltegravir in children and adolescents. The purpose of this study was to determine the appropriate dose for raltegravir across the pediatric age range from 4 weeks to 18 years of age, by acquiring short and long term safety data, intensive and population pharmacokinetic (PK) data, and efficacy experience with raltegravir in HIV-infected children and adolescents.
NCT00525733 ↗	Standard Antiretroviral v. Multi-class Therapy in Acutely HIV-1 Infected Antiretroviral-Naïve Subjects (ADARC 2007-01)	Completed	Aaron Diamond AIDS Research Center	N/A	2007-10-01	The researchers are involved in a phase II, randomized, two-arm study, comparing the efficacy, safety, and tolerability of open-label ritonavir (RTV)-enhanced darunavir with Truvada to a 5-drug multi-class regimen including truvada, darunavir/ritonavir/maraviroc/and raltegravir on acutely HIV-1-infected, antiretroviral (ARV) drug-naïve men and women. Subjects will participate for at least 60 weeks and up to 96 weeks if in the opinion of the investigator and patient that continued therapy is in the patient's best interest. Hypotheses: - Multi-class antiretroviral therapy (ART) is superior to RTV-enhanced ATV in combination with Emtricitabine/Tenofovir DF (FTC/TDF) with respect to suppression of viral replication. - Multi-class ART is superior to RTV-enhanced ATV in combination with FTC/TDF with respect to immune reconstitution in peripheral blood and in the gastrointestinal mucosa. - Multi-class ART is equivalent to RTV-enhanced ATV in combination with FTC/TDF with respect to tolerability.
NCT00525733 ↗	Standard Antiretroviral v. Multi-class Therapy in Acutely HIV-1 Infected Antiretroviral-Naïve Subjects (ADARC 2007-01)	Completed	Merck Sharp & Dohme Corp.	N/A	2007-10-01	The researchers are involved in a phase II, randomized, two-arm study, comparing the efficacy, safety, and tolerability of open-label ritonavir (RTV)-enhanced darunavir with Truvada to a 5-drug multi-class regimen including truvada, darunavir/ritonavir/maraviroc/and raltegravir on acutely HIV-1-infected, antiretroviral (ARV) drug-naïve men and women. Subjects will participate for at least 60 weeks and up to 96 weeks if in the opinion of the investigator and patient that continued therapy is in the patient's best interest. Hypotheses: - Multi-class antiretroviral therapy (ART) is superior to RTV-enhanced ATV in combination with Emtricitabine/Tenofovir DF (FTC/TDF) with respect to suppression of viral replication. - Multi-class ART is superior to RTV-enhanced ATV in combination with FTC/TDF with respect to immune reconstitution in peripheral blood and in the gastrointestinal mucosa. - Multi-class ART is equivalent to RTV-enhanced ATV in combination with FTC/TDF with respect to tolerability.
NCT00525733 ↗	Standard Antiretroviral v. Multi-class Therapy in Acutely HIV-1 Infected Antiretroviral-Naïve Subjects (ADARC 2007-01)	Completed	Pfizer	N/A	2007-10-01	The researchers are involved in a phase II, randomized, two-arm study, comparing the efficacy, safety, and tolerability of open-label ritonavir (RTV)-enhanced darunavir with Truvada to a 5-drug multi-class regimen including truvada, darunavir/ritonavir/maraviroc/and raltegravir on acutely HIV-1-infected, antiretroviral (ARV) drug-naïve men and women. Subjects will participate for at least 60 weeks and up to 96 weeks if in the opinion of the investigator and patient that continued therapy is in the patient's best interest. Hypotheses: - Multi-class antiretroviral therapy (ART) is superior to RTV-enhanced ATV in combination with Emtricitabine/Tenofovir DF (FTC/TDF) with respect to suppression of viral replication. - Multi-class ART is superior to RTV-enhanced ATV in combination with FTC/TDF with respect to immune reconstitution in peripheral blood and in the gastrointestinal mucosa. - Multi-class ART is equivalent to RTV-enhanced ATV in combination with FTC/TDF with respect to tolerability.

Clinical Trial Conditions for Isentress

Condition Name

Condition Name for Isentress
Intervention	Trials
HIV Infections	33
HIV	17
HIV Infection	12
HIV-1 Infection	6

Condition MeSH

Condition MeSH for Isentress
Intervention	Trials
HIV Infections	56
Acquired Immunodeficiency Syndrome	15
Infections	14
Infection	11

Clinical Trial Locations for Isentress

Trials by Country

Trials by Country for Isentress
Location	Trials
United States	96
Brazil	15
Canada	15
South Africa	14
France	10

Trials by US State

Trials by US State for Isentress
Location	Trials
California	12
North Carolina	7
New York	7
Massachusetts	7
Florida	7

Clinical Trial Progress for Isentress

Clinical Trial Phase

Clinical Trial Phase for Isentress
Clinical Trial Phase	Trials
Phase 4	30
Phase 3	12
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for Isentress
Clinical Trial Phase	Trials
Completed	67
Unknown status	9
Terminated	5

Clinical Trial Sponsors for Isentress

Sponsor Name

Sponsor Name for Isentress
Sponsor	Trials
Merck Sharp & Dohme Corp.	47
National Institute of Allergy and Infectious Diseases (NIAID)	7
Radboud University	5

Sponsor Type

Sponsor Type for Isentress
Sponsor	Trials
Other	117
Industry	69
NIH	13

Isentress (raltegravir) Clinical Trials Update, Market Analysis and Projection

Last updated: April 28, 2026

What is Isentress (raltegravir) and what is the current market reality?

Isentress is the brand name of raltegravir, an HIV-1 integrase strand transfer inhibitor (INSTI). The pivotal late-stage development for raltegravir occurred in the 2005-2008 period, with broad adoption after label expansion to include treatment-experienced and later treatment-naive populations.

From a market mechanics standpoint, raltegravir faces a mature INSTI category in which newer agents shifted share through once-daily dosing, improved tolerability convenience, and strong payer preference in fixed-dose combinations. As a result, Isentress is primarily a base-therapy and regimen-building product rather than a growth engine, with the market outcome driven more by guideline position and formularies than by new clinical development.

What is the clinical trials landscape for raltegravir today?

There is no clear signal of ongoing late-phase (Phase 3) pivotal trials that would restart a growth cycle for raltegravir. The clinical evidence base is concentrated in earlier randomized trials and subsequent label refinements and subgroup analyses. Current trial activity in raltegravir typically clusters into:

• Switch and durability studies within INSTI classes
• Special populations (adolescents, comorbidities, pregnancy sub-studies when present)
• Real-world evidence on outcomes and persistence
• Pharmacokinetic or drug-drug interaction studies tied to antiretrovirals and comedications

Given the absence of new Phase 3 outcomes that would materially change efficacy, safety, or positioning, the “clinical update” for an investment or R&D lens is best expressed as: Isentress is clinically stable and commercially dependent on existing label utility, not on a new registrational pipeline.

Evidence base (anchor trials that shaped use)

The core randomized studies that established raltegravir efficacy in treatment-experienced and later expanded indications are:

• BENCHMRK 1 and 2 (treatment-experienced, raltegravir vs optimized background therapy)
• STARTMRK (treatment-naive, raltegravir-based strategies)
• Subsequent comparative and extension evidence informing long-term outcomes and switching strategies

(Clinical trial identifiers and full results are not reprinted here because the request is a trials update and market projection for Isentress as a product; the detailed arm-level endpoints are not required to support the market thesis.)

How does raltegravir’s competitive position affect market performance?

Raltegravir competes across the INSTI class where prescribing behavior is shaped by:

• Dosing convenience (once-daily vs twice-daily)
• Formulary and step-edit rules
• Fixed-dose combination availability that reduces pill burden
• Switchability from older regimens and ability to maintain suppression
• Resistance profile and regimen durability in practice

In the INSTI category, newer products tend to consolidate preferred formulary status, with raltegravir increasingly positioned when:

• patients are stable and maintaining suppression,
• prescribers use established regimens,
• or access and payer rules favor older INSTIs.

What does the market projection imply for Isentress?

A credible projection for Isentress should be structured around three drivers:

1. Declining relative share vs newer INSTIs due to class evolution and payer preference
2. Baseline durability from patients already on stable regimens (low churn reduces immediate erosion)
3. Residual growth in geographies and segments where access timing, pricing, and formularies still include raltegravir

Because raltegravir has moved past the “pipeline-led growth” phase, market direction is driven more by lifecycle economics (generic competition, price compression, and shift to alternative INSTIs) than by incremental clinical differentiation.

Market projection framework (directional, scenario-based)

Below is a practical projection structure used in business planning for mature ART brands. (Numbers are not provided because the request did not specify a geography, forecasting horizon, or source dataset for current sales baselines.)

Time horizon	Likely demand shape	Primary driver
0-24 months	Flat to modest decline	Ongoing preference shift within INSTI class and price compression
24-48 months	Mid single-digit erosion in relative share	Intensifying conversion to newer INSTIs and combinations
48-60 months	Accelerating decline unless protected by access contracts	Formularies prioritize newer options; generic pricing compresses revenue

What would change the trajectory: a new label expansion that changes first-line standard-of-care positioning, a meaningful reduction in dosing burden (new formulation that is not standard twice daily), or new payer contracting that reverses access dynamics.

What matters for investors: regulatory and patent status

Isentress is a legacy small-molecule antiretroviral with patent expiry that has historically opened pathways for generics across major markets. The commercial impact of patent status is typically realized through:

• Generic entry and price erosion
• Loss of premium pricing
• Increased tender-driven contracting behavior

This legal and pricing backdrop explains why Isentress is evaluated as a mature cash-flow product rather than a late-cycle growth asset.

What are the most relevant R&D implications for competitors and acquirers?

For any strategy that targets raltegravir or its clinical niche, the actionable implication is simple: efficacy is established; the economic contest is about positioning and access. R&D and BD decisions should focus on:

• Opportunities to use raltegravir in legacy stabilization settings where it is already tolerated and effective
• Development of combination strategies where formularies still accept raltegravir-based regimens
• Acquisition rationales tied to market share inertia rather than to new clinical breakthroughs

Where does Isentress fit in current HIV guideline reality?

In contemporary practice, INSTI-based regimens are standard. Within INSTIs, newer agents dominate preferred pathways in many settings due to convenience and payer preference. Raltegravir still has clinical utility, but as a secondary or switch-friendly option more often than as a default first-line choice.

This category placement constrains growth. It also reduces the probability that future trials will be registrational rather than comparative or real-world.

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Key Takeaways

• Isentress (raltegravir) is clinically mature: its pivotal evidence base predates the current dominant INSTI standard-of-care.
• The market is category-driven, not pipeline-driven: demand is shaped by payer preference, dosing convenience, and fixed-dose combination availability.
• Projection trend is modest erosion: flat-to-decline near term followed by continued share loss as newer INSTIs consolidate formularies.
• R&D value is in lifecycle positioning: stabilization and access-driven niches, not new registrational efficacy breakthroughs.

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FAQs

1) Is there ongoing Phase 3 development for Isentress that could restart growth?
No clear, growth-restart Phase 3 signal is reflected in the product’s current clinical landscape; activity is generally comparative, subgroup, or real-world oriented.

2) What drives Isentress demand in 2026?
Formulary access, switch stability, and regimen inertia in patients already suppressed on raltegravir-based therapy.

3) How does the INSTI class shift affect raltegravir pricing power?
Newer INSTIs and fixed-dose combinations typically reduce raltegravir premium pricing via payer contracting and prescribing convenience.

4) What is the most likely market trajectory for revenue?
Revenue typically declines faster than prescriptions because price compression from generics and tendering offsets stable underlying use.

5) Where could Isentress remain strategically relevant?
In stable patients where clinicians prioritize regimen continuity, and in markets or contracts where formularies still include raltegravir options.

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References

[1] European Medicines Agency (EMA). Isentress (raltegravir) product information and assessment history.
[2] U.S. Food and Drug Administration (FDA). Isentress (raltegravir) prescribing information and label history.
[3] New England Journal of Medicine. BENCHMRK and STARTMRK trial publications and outcomes (raltegravir pivotal studies).
[4] IAS-USA (International Antiviral Society). HIV treatment recommendations and INSTI positioning in clinical practice (current editions).