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.
NCT00525733 ↗	Standard Antiretroviral v. Multi-class Therapy in Acutely HIV-1 Infected Antiretroviral-Naïve Subjects (ADARC 2007-01)	Completed	Rockefeller University	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.
NCT00537966 ↗	Characterization of Acute and Recent HIV-1 Infections in Zurich: a Long-term Observational Study	Recruiting	University of Zurich	N/A	2002-01-01	Aim of the study: To describe the epidemiology, longitudinally follow, test the effect of early antiretroviral treatment and investigate early events of virus-host interactions in patients with documented acute or recent HIV-1 infection in Zurich. Study design: This is an open label, non-randomized, observational, single center study at the University Hospital Zurich, Division of Infectious Diseases and Hospital Epidemiology. We aim at enrolling approximately 300 patients over a 10 year period. All patients who fulfill the inclusion criteria of a documented acute or recent HIV infection can participate in the study. Patients are offered early combination antiretroviral treatment (cART), if treatment start falls within 90 days after diagnosis of acute HIV-infection. After one year of suppressed HIV-plasma viremia (< 50 copies/ml) patients can chose to stop cART. Patients who have not chosen to undergo early-cART, respectively will stop cART after one year will be followed for a total of 5 years. Viral setpoints reached after treatment interruptions will be compared to historic controls and to the control group not having received cART during acute infection. A battery of virological and immunological assays will be performed on blood samples obtained to better understand early virus-host interactions, which are thought to play a key role in HIV-pathogenesis research. Summary: In summary, this study will provide comprehensive knowledge on early HIV-infection with regard to epidemiology, impact of early-cART on the course of disease and forms the base for a variety of translational research projects addressing early key pathogenesis events between virus and host, relevant for the course of disease, for transmission, for development of vaccines and new treatment strategies. - Trial with medicinal product

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 Future Projections

Last updated: October 28, 2025

Introduction

Isentress (raltegravir), developed by Merck & Co., is an integrase strand transfer inhibitor (INSTI) used as a core component in antiretroviral therapy (ART) for HIV-1 infection. Approved by the FDA in 2007, it revolutionized HIV treatment by offering a novel mechanism of action and improved safety profile. As the HIV/AIDS landscape evolves with generics, combination therapies, and new class development, analyzing Isentress's ongoing clinical trials, market dynamics, and growth projections offers essential insights for stakeholders.

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Clinical Trials Landscape and Updates

Current Clinical Trial Portfolio

Merck continues to explore Isentress’s potential beyond its initial indications, focusing on optimal use in combination regimens and addressing drug resistance challenges.

• Phase IV Studies: Post-marketing surveillance remains dominant, monitoring long-term safety, effectiveness, and resistance patterns in diverse populations, including pediatric, geriatric, and treatment-experienced patients.
• Combination Therapy Trials: Recent studies evaluate Isentress in fixed-dose combination tablets with other antiretrovirals to improve adherence, reduce pill burden, and combat resistance. For instance, trials are assessing its integration with drugs like Genvoya and BIC/FTC/TAF.
• Resistance and Pharmacokinetics: Ongoing trials evaluate raltegravir’s efficacy against resistant HIV strains, especially in patients with prior integrase inhibitor failure, and explore pharmacokinetic interactions with novel agents.

New Indications and Expanded Uses

Merck is investigating Isentress for:

• Pre-Exposure Prophylaxis (PrEP): While initially focused on treatment, trials are assessing its suitability for HIV prevention, though no significant approvals have materialized.
• Pediatric and Pregnant Populations: New formulations and clinical data aim to expand its use in children and pregnant women, addressing unmet needs in these vulnerable groups.

Emerging Data and Significance

Recent data suggest robust long-term virological suppression with minimal adverse effects, consolidating Isentress’s position in first-line and salvage therapy. The drug’s proven tolerability remains a key advantage despite emerging resistance, with ongoing research aiming to optimize dosing and improve patient outcomes.

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Market Analysis

Market Size and Evolution

The global HIV therapy market reached approximately $28 billion in 2022 and is projected to maintain a CAGR of 2.5–3% through 2030 [1]. Isentress holds a significant share within this space, particularly among integrase inhibitors, a class that accounts for over 40% of prescriptions in HIV regimens.

Competitive Landscape

• Major Competitors: Genvoya (Gilead), Dolutegravir-based products (ViiV Healthcare, Gilead), Bictegravir (Gilead).
• Differentiators for Isentress: Early approval, established safety profile, and widespread clinical experience. However, newer agents like dolutegravir and bictegravir offer once-daily dosing, higher barrier to resistance, and fewer drug interactions, challenging Isentress's dominance.

Current Sales and Revenue

Merck's HIV franchise, including Isentress, generated approximately $2.5 billion in 2022, with Isentress contributing notably to revenue from multi-tablet regimens and salvage therapies. The growth has been steady, with strategic efforts to expand indications and formulations.

Market Challenges

• Generic Competition: Patent cliffs and the availability of generics threaten pricing power.
• Resistance Development: The emergence of INSTI resistance narrows its utility in treatment-experienced patients.
• Formulary Preferences: Insurance preferences increasingly favor once-daily regimens with higher barriers to resistance.

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Future Market Projections and Strategic Outlook

Growth Opportunities

• Expanding Indications: There's strong potential in pediatric formulations and PrEP — areas with unmet demand.
• Combination Products: Innovating fixed-dose combinations with next-generation agents could revitalize its market appeal.
• Global Distribution: Increasing access in low- and middle-income countries (LMICs) offers growth, especially with licensing agreements and price reductions.

Potential Market Share Shift

While Isentress maintains a foothold, the market trajectory favors newer INSTIs like dolutegravir and bictegravir, offering convenience of once-daily dosing and improved resistance profiles. Merck's strategic focus involves positioning Isentress as part of salvage regimens and in regions where newer drugs are less accessible.

Forecast for 2025–2030

Based on current trajectories, Isentress’s market share will likely decline modestly in high-income markets but retain significant relevance in LMICs and specialized niches. Continued clinical trial success and alliance-driven formulations will be critical to maintaining revenue streams.

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Key Factors Impacting Isentress’s Market and Clinical Reach

• Regulatory Approvals: Expansion into pediatric and PrEP indications hinges on positive clinical trial outcomes and regulatory endorsement.
• Competitive Innovation: Adoption of fixed-dose combinations with novel agents can enhance adherence and resistance management.
• Patent and Pricing Strategies: Merck’s ability to safeguard formulary access in key markets through patent protections and pricing strategies influences future revenues.

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Key Takeaways

• Established Efficacy, Evolving Role: Isentress remains clinically relevant, especially in salvage therapy and specific populations, but faces stiff competition from newer INSTIs with superior dosing convenience.
• Clinical Trials to Drive Differentiation: Ongoing studies into pediatric use, drug resistance, and novel combinations will shape its future positioning.
• Market Dynamics Favor Innovation: Market share is expected to shift toward agents offering once-daily dosing and higher resistance barriers, impinging on Isentress's dominance but preserving niche relevance.
• Global Access as a Growth Driver: Expanding access in LMICs is critical for sustaining revenue amid patent expirations elsewhere.
• Strategic Focus: Merck’s emphasis on combination therapies and expanding indications can help mitigate erosion from generics and new entrants.

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FAQs

1. What is the current clinical status of Isentress?
Isentress remains approved globally for treating HIV-1 infection with ongoing clinical trials focusing on pediatric formulations, resistance management, and combination therapies, with some studies exploring preventive uses.

2. How does Isentress compare to newer INSTIs like dolutegravir?
While Isentress is effective, newer INSTIs like dolutegravir offer once-daily dosing, higher resistance barriers, and fewer drug interactions, making them preferred in first-line regimens.

3. What are the main challenges facing Isentress in the market?
Patent expirations, generic competitors, resistance development, and formulary shifts towards more convenient, high-barrier drugs challenge Isentress’s market share.

4. Is there potential for Isentress in HIV prevention?
Current data are limited, but trials investigating its role in pre-exposure prophylaxis (PrEP) are underway, though no approvals are imminent.

5. What strategies could extend Isentress’s market relevance?
Developing fixed-dose combinations, expanding indications, pursuing pediatric formulations, and increasing access in LMICs are key strategies for maintaining and growing its market footprint.

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References

1. MarketResearch.com. HIV/AIDS Drugs Market Overview, 2022.
2. Global Data. HIV Therapeutics Market Analysis & Forecast, 2022–2030.
3. FDA. Summary of Product Characteristics for Isentress (Raltegravir).
4. Merck & Co. Clinical trial registry and recent publications on Isentress.
5. IQVIA. Pharmaceutical Market Data, 2022.

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This analysis provides a comprehensive view into the current clinical landscape, market positioning, and future outlook for Isentress, facilitating informed strategic decision-making for industry stakeholders.