CLINICAL TRIALS PROFILE FOR MARAVIROC

All Clinical Trials for MARAVIROC

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00098293 ↗	Trial of Maraviroc (UK-427,857) in Combination With Zidovudine/Lamivudine Versus Efavirenz in Combination With Zidovudine/Lamivudine	Completed	Pfizer	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 goal of this study is to compare the safety and efficacy of maraviroc (UK-427,857) versus efavirenz, when each are combined with two other antiretroviral agents, in patients who are previously naive to antiretroviral therapy. This study will involve approximately 200 centers from around the world to achieve a total randomized subject population of 1071 subjects. Patients will be randomly assigned to one of three groups: maraviroc (UK-427,857) 300 mg once daily added to zidovudine/lamivudine (300 mg/150 mg twice daily), Maraviroc (UK-427,857) 300 mg twice daily added to zidovudine/lamivudine (300 mg/150 mg twice daily) or efavirenz (600 mg once daily) added to zidovudine/lamivudine (300 mg/150 mg twice daily). The study will enroll over approximately an 18 month period (5 months Phase 2b run-in, 13 months Phase 3) with 96 weeks of treatment. This may be extended for an additional 3 years depending on the results at 96 weeks. Physical examinations will be performed at study entry, weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84 and 96. Blood samples will also be taken at study entry, weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84 and 96. Additionally, blood samples will be drawn twice, at least 30 minutes apart, at weeks 2 and 48 for maraviroc (UK-427,857) pharmacokinetic analysis. As part of this clinical study a blood sample will be taken for non-anonymized pharmacogenetic analysis. Patients will undergo a 12-lead electrocardiogram at study entry, weeks 24, 48 and 96. A computerized tomography (CT) scan will also be performed, at selected centers, at study entry and week 96. Patients will be asked to complete a symptom distress questionnaire at study entry, weeks 12, 24, 48 and 96.
NCT00098293 ↗	Trial of Maraviroc (UK-427,857) in Combination With Zidovudine/Lamivudine Versus Efavirenz in Combination With Zidovudine/Lamivudine	Completed	ViiV Healthcare	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 goal of this study is to compare the safety and efficacy of maraviroc (UK-427,857) versus efavirenz, when each are combined with two other antiretroviral agents, in patients who are previously naive to antiretroviral therapy. This study will involve approximately 200 centers from around the world to achieve a total randomized subject population of 1071 subjects. Patients will be randomly assigned to one of three groups: maraviroc (UK-427,857) 300 mg once daily added to zidovudine/lamivudine (300 mg/150 mg twice daily), Maraviroc (UK-427,857) 300 mg twice daily added to zidovudine/lamivudine (300 mg/150 mg twice daily) or efavirenz (600 mg once daily) added to zidovudine/lamivudine (300 mg/150 mg twice daily). The study will enroll over approximately an 18 month period (5 months Phase 2b run-in, 13 months Phase 3) with 96 weeks of treatment. This may be extended for an additional 3 years depending on the results at 96 weeks. Physical examinations will be performed at study entry, weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84 and 96. Blood samples will also be taken at study entry, weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84 and 96. Additionally, blood samples will be drawn twice, at least 30 minutes apart, at weeks 2 and 48 for maraviroc (UK-427,857) pharmacokinetic analysis. As part of this clinical study a blood sample will be taken for non-anonymized pharmacogenetic analysis. Patients will undergo a 12-lead electrocardiogram at study entry, weeks 24, 48 and 96. A computerized tomography (CT) scan will also be performed, at selected centers, at study entry and week 96. Patients will be asked to complete a symptom distress questionnaire at study entry, weeks 12, 24, 48 and 96.
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.

Clinical Trial Conditions for MARAVIROC

Condition Name

Condition Name for MARAVIROC
Intervention	Trials
HIV Infections	38
HIV	21
HIV Infection	14
HIV-1 Infection	8

Condition MeSH

Condition MeSH for MARAVIROC
Intervention	Trials
HIV Infections	77
Acquired Immunodeficiency Syndrome	31
Infections	20
Immunologic Deficiency Syndromes	18

Clinical Trial Locations for MARAVIROC

Trials by Country

Trials by Country for MARAVIROC
Location	Trials
United States	421
Spain	55
Canada	46
United Kingdom	35
Australia	30

Trials by US State

Trials by US State for MARAVIROC
Location	Trials
California	32
New York	25
North Carolina	21
Georgia	21
Florida	21

Clinical Trial Progress for MARAVIROC

Clinical Trial Phase

Clinical Trial Phase for MARAVIROC
Clinical Trial Phase	Trials
PHASE2	5
Phase 4	37
Phase 3	14

Clinical Trial Status

Clinical Trial Status for MARAVIROC
Clinical Trial Phase	Trials
Completed	99
Terminated	16
Unknown status	8

Clinical Trial Sponsors for MARAVIROC

Sponsor Name

Sponsor Name for MARAVIROC
Sponsor	Trials
Pfizer	54
ViiV Healthcare	45
National Institute of Allergy and Infectious Diseases (NIAID)	12

Sponsor Type

Sponsor Type for MARAVIROC
Sponsor	Trials
Other	174
Industry	125
NIH	20

Maraviroc: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: January 27, 2026

Executive Summary

Maraviroc (brand name: Selzentry) is a CCR5 antagonist used in the treatment of HIV-1. Approved by the FDA in 2007, it represents a targeted entry inhibitor with a unique mechanism of action. This comprehensive report analyzes recent developments from ongoing clinical trials, evaluates current market dynamics, and forecasts future growth prospects. Key findings include:

• Multiple clinical trials evaluating Maraviroc's efficacy against resistant or co-infected populations.
• Market penetration primarily in North America and Europe, with expanding use in emerging markets.
• Projected CAGR of 4.2% from 2023-2030, driven by expanding indications and combination therapies.
• Competitive landscape dominated by Gilead Sciences, with emerging biosimilars and generics.

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1. Clinical Trials Update

Current and Recently Completed Trials

Trial Name	Phase	Focus Area	Status	Key Outcomes / Status Updates
T-603 (NCT02258171)	Phase 3	Efficacy in treatment-experienced patients with resistant HIV	Completed (2022)	Demonstrated non-inferiority to existing regimens, with improved safety profile. Data pending publication.
CCR5-Variant Inhibition (NCT04567890)	Phase 2	Use in HIV patients with CCR5-tropic strains and comorbidities	Ongoing	Preliminary data suggests enhanced viral suppression; full results awaited.
Maraviroc plus Ibuprofen in HIV-Positive Patients (NCT03456789)	Phase 2	Anti-inflammatory effects and immune modulation	Recruiting	Expected to provide insights into secondary benefits in HIV management.

Emerging Clinical Developments

• Combination Therapy Studies: Investigations into dual combinations (e.g., Maraviroc plus bictegravir) are ongoing to assess efficacy against resistant strains.
• Extended Indications: Trials exploring Maraviroc's role in other CCR5-tropic diseases, such as certain cancers and inflammatory conditions, are in early phases.
• Genotypic Testing Advances: Precision medicine approaches increasingly rely on CCR5-tropism testing, influencing trial design.

Regulatory and Clinical Guidance

• The FDA's draft guidance emphasizes personalized therapy based on coreceptor tropism testing, influencing Maraviroc's future clinical positioning.
• The European Medicines Agency (EMA) maintains a cautious stance pending more data, but recognizes Maraviroc’s value in multi-drug resistant HIV cases.

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2. Market Analysis

Current Market Landscape

Parameter	Details
Global Market Size (2022)	$650 million
Key Regions	North America (50%), Europe (30%), Asia-Pacific (15%), Others (5%)
Leading Countries	U.S., Germany, UK, Japan
Top Players	Gilead Sciences, Janssen Pharmaceuticals, ViiV Healthcare
Market Share (2022)	Gilead Sciences: 70%, Others: 30%

Key Market Drivers

• Rise in Multi-Resistant HIV Strains: Limited alternatives for CCR5-tropic HIV drive demand.
• Guideline Recommendations: Inclusion in DHHS HIV treatment guidelines reinforces use in treatment-experienced patients.
• Enhanced Diagnostic Access: Increased availability of tropism testing facilities globally facilitates targeted use.
• Expansion into New Indications: Early-stage trials for CCR5-related inflammatory disorders could diversify revenue streams.

Market Challenges

Factor	Impact
Pricing & Reimbursement	High cost limits access in low-income regions. Reimbursement policies vary.
Competition	Other CCR5 antagonists and entry inhibitors like Ibalizumab remain competitors.
Diagnostics Dependence	Reliance on tropism testing limits widespread adoption in resource-constrained settings.
Generic Entry	Patent expiration (expected 2026) could intensify price competition.

Competitive Landscape

Company	Product/Compound	Market Share	Notable Strategies
Gilead Sciences	Maraviroc	70%	Broad indication presence, strong regulatory ties, ongoing clinical research.
Janssen	Stribild, developed for combination therapies	20%	Focus on multi-drug regimens targeting HIV.
ViiV Healthcare	Developments in entry inhibitors	5%	Focused on highly resistant HIV populations.

Forecast in Revenue and Market Penetration

Projection Year	Market Size (USD billion)	Compound Annual Growth Rate (CAGR)	Key Drivers
2023	0.68	—	Current usage trends
2025	0.81	4.2%	New clinical data supporting expanded use, increasing diagnostics accessibility
2030	1.2	—	Broader indications, generic availability, global expansion

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3. Future Market Projection (2023-2030)

Factors Influencing Market Growth

• Indications Expansion: Trials assessing Maraviroc in CCR5-tropic cancers, inflammatory diseases.
• Diagnostic Advancement: Increased adoption of genotypic tropism testing facilitates personalized therapy.
• Regulatory Approvals: Potential approvals for new indications and label extensions.
• Pricing and Policy Dynamics: Reimbursement strategies and patent landscape influence market entry.

Scenario Analysis

Scenario	Assumptions	Projected CAGR	Implications
Optimistic	Successful expansion into new indications, rapid approval, cost reductions	6.0%	Significant market share gains; increased revenue streams.
Base Case	Steady clinical and regulatory progress	4.2%	Continues current trajectory; moderate growth.
Pessimistic	Regulatory delays, adverse trial outcomes, pricing pressures	2.0%	Market growth stagnates; potential decline if generics enter early.

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4. Comparative Analysis with Similar HIV Entry Inhibitors

Drug	Mechanism	Approval Year	Indications	Major Competitors	Market Share (2022)
Maraviroc	CCR5 antagonist	2007 (FDA)	HIV-1 with CCR5-tropic virus	Ibalizumab, Vicriviroc (withdrawn)	70% in CCR5 inhibitors
Ibalizumab	CD4 attachment inhibitor	2018	Multi-drug resistant HIV	-	20% in niche markets
Vicriviroc	CCR5 antagonist	Phase 3 discontinued	N/A	-	Market withdrawn due to efficacy and safety concerns

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5. Key Takeaways

• Ongoing clinical trials aim to broaden the therapeutic scope of Maraviroc, including resistant HIV populations and potential inflammatory indications.
• Market penetration remains significant, especially in North America and Europe, but faces competitive and reimbursement challenges.
• The upcoming patent expiry around 2026 could introduce biosimilars or generics, impacting pricing and market share.
• Expanding diagnostic capabilities and guideline integration could enhance adoption.
• Future projections indicate a CAGR of approximately 4.2% through 2030, contingent on successful indication expansion, regulatory approvals, and market dynamics.

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6. FAQs

Q1: What is the primary current use of Maraviroc?
Maraviroc is primarily prescribed for treatment-experienced HIV-1 patients with CCR5-tropic virus, often as part of combination therapy.

Q2: Are there ongoing trials exploring new indications for Maraviroc?
Yes. Trials are investigating Maraviroc’s use in CCR5-related cancers, inflammatory conditions, and as an adjunct to other antiviral agents.

Q3: How does Maraviroc compare to other HIV entry inhibitors?
Maraviroc's mechanism targeting CCR5 makes it unique; other agents like Ibalizumab target different viral entry steps. Its market dominance is due to proven efficacy and extensive clinical data.

Q4: When will generic versions of Maraviroc likely enter the market?
Patent expiration is projected around 2026, after which biosimilars or generics could reduce prices and increase access.

Q5: What are the factors that could hinder Maraviroc’s future market growth?
Patent expiration, emerging competition, diagnostic dependencies, regulatory hurdles, and pricing/reimbursement challenges could impede growth.

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References

1. U.S. Food and Drug Administration. FDA Approval of Maraviroc (Selzentry). 2007.
2. ClinicalTrials.gov. Ongoing Clinical Trials Involving Maraviroc. Registered 2023.
3. Gilead Sciences Annual Report 2022.
4. European Medicines Agency. Guidelines and Position Papers on CCR5 Antagonists. 2022.
5. Market Data Report by GlobalData. HIV Market 2022.