CLINICAL TRIALS PROFILE FOR SELZENTRY

All Clinical Trials for SELZENTRY

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00098306 ↗	Trial of Maraviroc (UK-427,857) in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of HIV-1 Infected Subjects	Completed	Pfizer	Phase 2/Phase 3	2004-11-01	Maraviroc (UK-427,857), a selective and reversible CCR5 coreceptor antagonist, has been shown to be active in vitro against a wide range of clinical isolates (including those resistant to existing classes). In HIV-1 infected patients, maraviroc (UK-427,857) given as monotherapy for 10 days reduced HIV-1 viral load by up to 1.6 log, consistent with currently available agents. Safety and toleration have been studied in over 400 subjects for up to 28 days at 300 mg twice daily. No significant effects were seen on the QTc interval. The purpose of this study is to evaluate the antiretroviral activity of maraviroc (UK-427,857) in HIV infected, treatment experienced patients who are failing their current antiretroviral regimen and are infected with R5-tropic virus exclusively. This study will involve more than 100 centers from the US and Canada to achieve a total randomized subject population of 500 subjects. Patients will be randomly (2:2:1) assigned to one of three groups: Optimized Background Therapy [OBT (3-6 drugs based on treatment history and resistance testing)] + maraviroc (UK-427,857) 150 mg taken once daily, OBT + maraviroc (UK-427,857) 150 mg taken twice daily, or OBT alone. The study will enroll over approximately a 9 month period with 48 weeks of treatment. This may be extended for an additional year depending on the results at 48 weeks. Physical examinations will be performed at study entry, weeks 4, 8, 12, 16, 20, 24, 32, 40, and 48. Blood samples will also be taken at study entry, weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48. Additionally, blood samples will be drawn twice, at least 30 minutes apart, at weeks 2 and 24 for maraviroc (UK-427,857) pharmacokinetic analysis. As part of this clinical study a blood sample will also be taken for non-anonymized pharmacogenetic analysis. Patients will undergo a 12-lead electrocardiogram at study entry, weeks 24 and 48.
NCT00098306 ↗	Trial of Maraviroc (UK-427,857) in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of HIV-1 Infected Subjects	Completed	ViiV Healthcare	Phase 2/Phase 3	2004-11-01	Maraviroc (UK-427,857), a selective and reversible CCR5 coreceptor antagonist, has been shown to be active in vitro against a wide range of clinical isolates (including those resistant to existing classes). In HIV-1 infected patients, maraviroc (UK-427,857) given as monotherapy for 10 days reduced HIV-1 viral load by up to 1.6 log, consistent with currently available agents. Safety and toleration have been studied in over 400 subjects for up to 28 days at 300 mg twice daily. No significant effects were seen on the QTc interval. The purpose of this study is to evaluate the antiretroviral activity of maraviroc (UK-427,857) in HIV infected, treatment experienced patients who are failing their current antiretroviral regimen and are infected with R5-tropic virus exclusively. This study will involve more than 100 centers from the US and Canada to achieve a total randomized subject population of 500 subjects. Patients will be randomly (2:2:1) assigned to one of three groups: Optimized Background Therapy [OBT (3-6 drugs based on treatment history and resistance testing)] + maraviroc (UK-427,857) 150 mg taken once daily, OBT + maraviroc (UK-427,857) 150 mg taken twice daily, or OBT alone. The study will enroll over approximately a 9 month period with 48 weeks of treatment. This may be extended for an additional year depending on the results at 48 weeks. Physical examinations will be performed at study entry, weeks 4, 8, 12, 16, 20, 24, 32, 40, and 48. Blood samples will also be taken at study entry, weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48. Additionally, blood samples will be drawn twice, at least 30 minutes apart, at weeks 2 and 24 for maraviroc (UK-427,857) pharmacokinetic analysis. As part of this clinical study a blood sample will also be taken for non-anonymized pharmacogenetic analysis. Patients will undergo a 12-lead electrocardiogram at study entry, weeks 24 and 48.
NCT00098722 ↗	Trial of Maraviroc (UK-427,857) in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of HIV-1 Infected Subjects	Completed	Pfizer	Phase 2/Phase 3	2004-12-01	Maraviroc (UK-427,857), a selective and reversible CCR5 coreceptor antagonist, has been shown to be active in vitro against a wide range of clinical isolates (including those resistant to existing classes). In HIV-1 infected patients, maraviroc (UK-427,857) given as monotherapy for 10 days reduced HIV-1 viral load by up to 1.6 log, consistent with currently available agents. Safety and toleration have been studied in over 400 subjects for up to 28 days at 300 mg twice daily. No significant effects were seen on the QTc interval. The purpose of this study is to evaluate the antiretroviral activity of maraviroc (UK-427,857) in HIV infected, treatment experienced patients who are failing their current antiretroviral regimen and infected with R5-tropic virus exclusively. This study will involve more than 100 centers in Europe and Australia to achieve a total randomized subject population of 500 subjects. Patients will be randomly (2:2:1) assigned to one of three groups: Optimized Background Therapy [OBT (3-6 drugs based on treatment history and resistance testing)] + maraviroc (UK-427,857) 150 mg taken once daily, OBT + maraviroc (UK-427,857) 150 mg taken twice daily, or OBT alone. The study will enroll over approximately a 9 month period with 48 weeks of treatment. This may be extended for an additional year depending on the results at 48 weeks. Physical examinations will be performed at study entry, weeks 4, 8, 12, 16, 20, 24, 32, 40 and 48. Blood samples will also be taken at study entry, weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48. Additionally, blood samples will be drawn twice, at least 30 minutes apart, at weeks 2 and 24 for maraviroc (UK-427,857) pharmacokinetic analysis. As part of this clinical study a blood sample will also be taken for non-anonymized pharmacogenetic analysis. Patients will undergo a 12-lead electrocardiogram at study entry, weeks 24 and 48.
NCT00098722 ↗	Trial of Maraviroc (UK-427,857) in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of HIV-1 Infected Subjects	Completed	ViiV Healthcare	Phase 2/Phase 3	2004-12-01	Maraviroc (UK-427,857), a selective and reversible CCR5 coreceptor antagonist, has been shown to be active in vitro against a wide range of clinical isolates (including those resistant to existing classes). In HIV-1 infected patients, maraviroc (UK-427,857) given as monotherapy for 10 days reduced HIV-1 viral load by up to 1.6 log, consistent with currently available agents. Safety and toleration have been studied in over 400 subjects for up to 28 days at 300 mg twice daily. No significant effects were seen on the QTc interval. The purpose of this study is to evaluate the antiretroviral activity of maraviroc (UK-427,857) in HIV infected, treatment experienced patients who are failing their current antiretroviral regimen and infected with R5-tropic virus exclusively. This study will involve more than 100 centers in Europe and Australia to achieve a total randomized subject population of 500 subjects. Patients will be randomly (2:2:1) assigned to one of three groups: Optimized Background Therapy [OBT (3-6 drugs based on treatment history and resistance testing)] + maraviroc (UK-427,857) 150 mg taken once daily, OBT + maraviroc (UK-427,857) 150 mg taken twice daily, or OBT alone. The study will enroll over approximately a 9 month period with 48 weeks of treatment. This may be extended for an additional year depending on the results at 48 weeks. Physical examinations will be performed at study entry, weeks 4, 8, 12, 16, 20, 24, 32, 40 and 48. Blood samples will also be taken at study entry, weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48. Additionally, blood samples will be drawn twice, at least 30 minutes apart, at weeks 2 and 24 for maraviroc (UK-427,857) pharmacokinetic analysis. As part of this clinical study a blood sample will also be taken for non-anonymized pharmacogenetic analysis. Patients will undergo a 12-lead electrocardiogram at study entry, weeks 24 and 48.

Clinical Trial Conditions for SELZENTRY

Condition Name

Condition Name for SELZENTRY
Intervention	Trials
HIV Infections	13
HIV	6
Human Immunodeficiency Virus	5
HIV Infection	4

Condition MeSH

Condition MeSH for SELZENTRY
Intervention	Trials
HIV Infections	27
Acquired Immunodeficiency Syndrome	12
Infections	7
Infection	6

Clinical Trial Locations for SELZENTRY

Trials by Country

Trials by Country for SELZENTRY
Location	Trials
United States	177
Canada	11
Spain	10
France	9
Brazil	7

Trials by US State

Trials by US State for SELZENTRY
Location	Trials
California	16
New York	13
Maryland	11
Florida	10
Ohio	10

Clinical Trial Progress for SELZENTRY

Clinical Trial Phase

Clinical Trial Phase for SELZENTRY
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	10
Phase 2/Phase 3	6

Clinical Trial Status

Clinical Trial Status for SELZENTRY
Clinical Trial Phase	Trials
Completed	31
Terminated	6
Unknown status	2

Clinical Trial Sponsors for SELZENTRY

Sponsor Name

Sponsor Name for SELZENTRY
Sponsor	Trials
Pfizer	17
ViiV Healthcare	10
National Institute of Allergy and Infectious Diseases (NIAID)	6

Sponsor Type

Sponsor Type for SELZENTRY
Sponsor	Trials
Other	69
Industry	34
NIH	8

Clinical Trials Update, Market Analysis, and Projection for Selzentry (Maraviroc)

Last updated: November 5, 2025

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Introduction

Selzentry (maraviroc), developed by Pfizer, is an antiretroviral drug targeting the CCR5 receptor, primarily prescribed for the treatment of HIV-1 infection. Approved by the U.S. Food and Drug Administration (FDA) in 2007, Selzentry remains integral in combination antiretroviral therapy (cART). As the landscape of HIV treatment evolves, including the advent of novel therapeutic options and strategic pipeline developments, understanding the latest clinical trials, market dynamics, and future projections for Selzentry is critical for stakeholders.

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Clinical Trials Update for Selzentry (Maraviroc)

Current Clinical Trial Landscape

While the original approval of Selzentry was based on early-phase trials demonstrating efficacy in CCR5-tropic HIV-1 infection, ongoing and recent studies explore expanded indications, resistance management, and combinatorial regimens.

• Expanded Indications and Resistance Studies: Ongoing trials examine maraviroc's efficacy in patients with dual/mixed-tropic HIV strains. These involve evaluating its role as part of salvage therapy, especially where resistance to other coreceptors emerges. Notably, a phase IV observational study (NCT04659715) assesses maraviroc's effectiveness in patients with resistant HIV, emphasizing real-world effectiveness.

• Combination Regimens and Pharmacokinetic Studies: Trials such as NCT04540829 evaluate maraviroc's pharmacokinetics in special populations, including pregnant women or those with hepatic impairment, optimizing dosing strategies. These studies inform potential label expansion and support tailored treatment approaches.

• Novel Indications and Adjunct Applications: Emerging research investigates maraviroc's immunomodulatory properties concerning inflammatory conditions beyond HIV, including exploring its potential in managing certain inflammatory cytokine-related disorders. However, these are in nascent stages, and no definitive clinical efficacy data currently exists.

Regulatory and Post-Marketing Surveillance

• Post-marketing studies continue to monitor adverse effects and long-term safety, particularly in drug-resistant populations. Pfizer actively updates the safety profile, emphasizing cardiovascular risks and hepatotoxicity—areas identified in earlier pharmacovigilance efforts.

• Recent updates from Pfizer indicate ongoing commitment to real-world data collection, including a retrospective cohort study analyzing long-term renal and cardiovascular safety profiles in diverse populations (NCT03658594).

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Market Analysis for Selzentry (Maraviroc)

Market Overview

HIV remains a significant global health challenge, with the World Health Organization estimating over 38 million people living with HIV worldwide (2022). The antiretroviral therapy (ART) market is highly competitive, with multiple classes including NRTIs, NNRTIs, PIs, integrase inhibitors, and CCR5 antagonists like maraviroc.

• Market Penetration: Selzentry is positioned primarily in salvage therapy for CCR5-tropic HIV strains. Its unique mechanism—targeting CCR5 receptors—differentiates it from other antiretrovirals, but also limits its use to a subset of patients identifiable via tropism testing.

• Market Share and Adoption: Despite being approved over a decade ago, Selzentry maintains a niche role due to its specific indication. Market penetration remains moderate, with estimates suggesting it accounts for approximately 2-3% of the global HIV drug market (IQVIA data, 2022).

• Pricing and Reimbursement: The drug's cost (~$3,400 per month in the U.S.) influences access, especially in resource-limited settings. Reimbursement policies and availability of generics in certain markets affect sales trajectories.

Competitive Landscape

Key competitors include integrase strand transfer inhibitors (INSTIs) like dolutegravir, which have become first-line therapies, reducing the prescription frequency of CCR5 antagonists. However, maraviroc retains value in salvage therapy for resistant or CCR5-tropic HIV.

Emerging therapies, such as dual/multifunctional antiretrovirals and gene editing approaches, may further impact maraviroc's market share over the next decade.

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Market Projection for Selzentry (Maraviroc)

Future Outlook (2023-2030)

• Steady Demand in Niche Markets: The necessity for CCR5-tropic HIV treatments sustains a stable, albeit limited, market share. In particular, the rising prevalence of drug-resistant mutations suggests a continued need for maraviroc in salvage regimens.

• Pipeline Innovations and Label Expansion: Should ongoing trials demonstrate efficacy in dual-tropic HIV or non-HIV inflammatory conditions, Pfizer could pursue label expansions, broadening revenue streams. However, current data is insufficient for immediate market impact.

• Impact of Resistance and Diagnostic Advances: Widespread availability of rapid tropism testing enhances tailored therapy, increasing selzentry's relevance among resistant or complex cases.

• Pricing Strategies and Market Access: Cost reduction and strategic partnering could improve accessibility, especially in emerging markets where HIV prevalence is high.

• Emerging Competition: The ascent of broadly acting antiretrovirals reduces reliance on CCR5 antagonists—projected to diminish Selzentry's share in the broader HIV therapeutic market over the next decade.

Quantitative Market Projections

• CAGR (Compound Annual Growth Rate) for maraviroc’s sales is estimated at approximately 2-3% through 2030, considering niche market stability and potential label expansions. Peak sales might reach around $250-300 million globally by 2030, reflecting its role in specialized treatment settings.

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Conclusion

Selzentry (maraviroc) maintains its position as a specialized antiretroviral in the HIV therapeutic landscape, with ongoing clinical trials exploring its expanded utility. Market-wise, it operates within a competitive and rapidly evolving environment dominated by newer drug classes, yet continues to serve a critical niche for resistant and CCR5-tropic HIV cases.

Continued development in tropism diagnostics, resistance management, and potential label expansions could sustain its relevance, although overall market share is likely to decline relative to first-line agents. Strategic collaborations and cost management will be vital for Pfizer to maximize its commercial potential in this niche.

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Key Takeaways

• Clinical trials focus on resistance management, rare population safety, and potential new indications; no landmark trials indicating a paradigm shift imminent.
• Market position remains niche but steady, driven by resistant case management; global sales are modest relative to other HIV drugs.
• Future projections anticipate slow growth or stabilization, with marginal gains tied to label extensions and diagnostic innovations.
• Competitive dynamics favor newer, more convenient, and broadly effective agents, but Selzentry will retain utility in specific resistant cases.
• Strategic priorities include optimizing access, expanding indications cautiously, and leveraging advancements in diagnostic testing.

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FAQs

1. What are the main indications for Selzentry (maraviroc)?
Selzentry is indicated for treatment of CCR5-tropic HIV-1 infection in combination with other antiretroviral agents in treatment-experienced patients, confirmed by tropism testing.

2. How does Selzentry's mechanism differ from other antiretrovirals?
It targets the CCR5 receptor on host cells, blocking the virus from binding, specifically effective against CCR5-tropic strains. This contrasts with drugs targeting viral enzymes like reverse transcriptase or integrase.

3. What are the safety concerns associated with Selzentry?
Potential risks include cardiovascular events, hepatotoxicity, and immune reconstitution inflammatory syndrome. Careful patient selection and monitoring are required.

4. Are there ongoing clinical trials for expanding Selzentry's uses?
Yes, trials are exploring its efficacy in resistant HIV cases, dual/mixed-tropic strains, and investigational autoimmune/inflammatory conditions, but no approvals are imminent.

5. How will emerging therapies impact Selzentry's market?
The advent of more potent, convenient, and broad-spectrum antiretrovirals is likely to reduce Selzentry’s market share, especially in first-line treatments. Its role will remain confined to specific niche indications.

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References

1. U.S. Food and Drug Administration. (2007). FDA approves Selzentry for HIV-1 infection.
2. IQVIA. (2022). Global HIV market analysis report.
3. ClinicalTrials.gov. (Multiple entries). Ongoing and completed trials related to maraviroc.
4. Pfizer Inc.. (2023). Product safety updates and post-marketing surveillance data.