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.
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.

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
Immunologic Deficiency Syndromes	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
Ohio	10
Florida	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
Recruiting	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

Summary

Last updated: February 4, 2026

Selzentry (maraviroc) is an antiretroviral developed by ViiV Healthcare for the treatment of HIV-1 infection. Its clinical trial pipeline has been stable with confirmatory data supporting its efficacy. Market adoption remains steady, driven by its specific mechanism of CCR5 antagonism. Projected growth is moderate, influenced by competition from other antiretrovirals and adherence to regulatory approvals.

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What Is the Current Status of Clinical Trials for Selzentry?

ViiV Healthcare maintains an active portfolio of trials to explore expanded indications, optimize dosing, and evaluate long-term safety. The drug’s primary label approval covers treatment-experienced HIV-1 patients with CCR5-tropic virus.

Ongoing and Completed Trials

• Phase 3 Trials: The phase 3 MOTIVATE and MERIT studies established the efficacy of maraviroc in treatment-experienced, CCR5-tropic HIV patients.
• Additional Trials: Current trials assess maraviroc in pediatric populations, including a phase 2 study evaluating safety and pharmacokinetics in children aged 2–18 (ClinicalTrials.gov ID: NCT02278409).
• Expanded Indications: Trials examine maraviroc's potential use in non-HIV indications, such as graft-versus-host disease (GVHD) and certain inflammatory conditions, but these are at early stages.

Regulatory Developments

In 2018, the FDA approved a new formulation, maraviroc film-coated tablets, intended to improve patient adherence. No recent substance approvals or label expansions have occurred since.

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What Is the Current Market Landscape for Selzentry?

Selzentry faces competition within the HIV treatment market, which includes integrase inhibitors, nucleoside reverse transcriptase inhibitors, and other CCR5 antagonists:

Competitor	Mechanism	Market Share (2022)	Key Advantages
Biktarvy (Gilead)	Integrase inhibitor	33%	Convenience, high efficacy
ViiV’s Tivicay (dolutegravir)	Integrase inhibitor	25%	Fewer adverse effects, high barrier to resistance
Selzentry (maraviroc)	CCR5 antagonist	5-7%	Specific target for CCR5-tropic strains, functional in salvage therapy

Sales of Selzentry were approximately $79 million in 2022, representing a stable but niche segment. The drug’s market penetration is constrained by the need for tropism testing before administration, since maraviroc is ineffective against CXCR4-tropic and dual-tropic strains.

Market Trends and Challenges

• The HIV drug market sustains a compound annual growth rate (CAGR) of 3.4% over the past five years.
• Therapies with simplified regimens and fewer testing requirements dominate market share.
• Biannual resistance testing complicates therapy initiation; this discourages broader use of CCR5 antagonists like maraviroc.

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What Are the Market Projections for Selzentry?

By 2027, the global HIV treatment market is expected to grow to USD 27.6 billion, driven by increased diagnosis rates and adherence strategies.

market share forecasts

Selzentry’s share is projected to remain around 6-8% of the CCR5 antagonist segment, equating to ~$150 million annually by 2027, assuming stable pricing and continued approval status.

Key factors influencing projection

• Advances in tropism testing: Faster, cheaper testing could expand maraviroc’s use.
• Regulatory approvals for new indications: The absence of recent label expansions limits growth.
• Emerging competitors: New agents with potent activity and simplified design may erode market share unless Selzentry expands indications or improves formulation.

Potential Growth Drivers

• Special programs for multidrug-resistant HIV cases.
• Interest in maraviroc for off-label uses in inflammatory and immune conditions.
• Development of co-formulations to enhance compliance.

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What Are the Key Risks and Opportunities?

Risks

• Competition from integrase-based regimens with higher efficacy and fewer monitoring requirements.
• Price pressures from biosimilars and generic competitors if patent expiry occurs.
• Limited scalability due to dependence on tropism testing infrastructure.

Opportunities

• Developing oral, short-duration regimens for multidrug-resistant HIV.
• Leveraging the drug’s mechanism for new inflammatory or immune syndromes.
• Collaborations with diagnostic companies for rapid tropism testing.

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Key Takeaways

• Clinical trials for Selzentry have focused on expanded pediatric use and exploration of new indications.
• The drug holds a niche market position, with about 5-7% share within the CCR5 antagonist segment.
• Sales are stable but limited by testing requirements and competition.
• Market projections suggest steady growth, contingent on regulatory approvals and innovation in tropism testing.
• Strategic focus should include expanding indications and facilitating ease of use to sustain market relevance.

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FAQs

1. Are there any recent label changes or approvals for Selzentry?
   No, the most recent approval was in 2018 for maraviroc film-coated tablets. No recent label expansions are recorded.

2. What are the main barriers to better market penetration?
   The need for tropism testing, patient selection constraints, and competition from more convenient regimens.

3. Is there ongoing research for new uses of maraviroc?
   Early-stage studies explore application in immune-related disorders, but these are not yet advanced.

4. How does Maraviroc compare to newer HIV drugs?
   It offers a targeted mechanism for CCR5-tropic strains but lags behind integrase inhibitors in efficacy, resistance barrier, and convenience.

5. What is the outlook for Selzentry in the next five years?
   Expect continued niche usage with potential growth if new indications are approved and tropism testing methods improve.

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Sources

1. [1] ViiV Healthcare. Selzentry (maraviroc) clinical pharmacology. 2018.
2. [2] ClinicalTrials.gov. Multiple ongoing studies involving maraviroc.
3. [3] IQVIA. HIV drug market data, 2022.
4. [4] EvaluatePharma. Global HIV market forecast, 2022-2027.
5. [5] FDA. Maraviroc approval history and labeling.