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.

Clinical Trial Conditions for MARAVIROC

Condition Name

Condition Name for MARAVIROC
Intervention	Trials
HIV Infections	38
HIV	20
HIV Infection	14

Condition MeSH

Condition MeSH for MARAVIROC
Intervention	Trials
HIV Infections	77
Acquired Immunodeficiency Syndrome	30
Infections	20

Clinical Trial Locations for MARAVIROC

Trials by Country

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Trials by Country for MARAVIROC
Location	Trials
United States	419
Spain	53
Canada	46
United Kingdom	35
Australia	30

Trials by US State

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Trials by US State for MARAVIROC
Location	Trials
California	31
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
Phase 4	37
Phase 3	14
Phase 2/Phase 3	7

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	170
Industry	124
NIH	19

Maraviroc: Clinical Trials, Market Analysis, and Projections

Introduction

Maraviroc, known by the trade names Celsentri in Europe and Selzentry in the United States, is a unique antiretroviral drug that belongs to the class of CCR5 inhibitors. It prevents HIV from entering uninfected cells by blocking the CCR5 receptor on the surface of immune cells. Here, we will delve into the current state of clinical trials, market analysis, and future projections for maraviroc.

Clinical Trials and Efficacy

Current Clinical Trials

Maraviroc is being explored in various clinical settings beyond its traditional use in HIV treatment. For instance, a study is ongoing to evaluate the safety and efficacy of a combination of drugs including maraviroc, cyclophosphamide, and bortezomib in protecting against certain types of cancer[4].

In the context of HIV prevention, a phase 2 clinical trial has investigated the pharmacokinetics (PK) of a single oral dose of maraviroc (300mg) in healthy adults. This study aimed to determine drug levels in various HIV exposure compartments and found that maraviroc concentrations remained above the minimum effective concentration (MEC) in most compartments for up to 72 hours, suggesting its potential as a pre-exposure prophylaxis (PrEP) agent[1].

Efficacy in Treatment-Experienced Patients

Maraviroc has been approved for use in treatment-experienced individuals with CCR5-tropic virus. The MOTIVATE studies, which enrolled highly treatment-experienced patients, demonstrated that adding maraviroc to optimized background antiretroviral therapy (ART) significantly improved viral load suppression compared to placebo. However, its effectiveness is limited to patients with CCR5-tropic virus, and treatment failure can occur if the virus shifts to X4-tropic or dual/mixed tropic virus[5].

Market Analysis

Market Size and Growth

The global maraviroc market was valued at USD 370.1 million in 2023 and is projected to reach USD 750.1 million by 2030, growing at a Compound Annual Growth Rate (CAGR) of 9.1%. This growth is driven by increasing demand for maraviroc in hospital and drug store applications globally[2].

Key Players and Market Segmentation

The market is dominated by key players such as ViiV Healthcare, SANDOZ, and HETERO. The market is segmented based on type, application, and geography, with North America, Europe, Asia Pacific, and the rest of the world being the primary geographical segments. The report provides a detailed analysis of market segments, market outlook, competitive landscape, and company profiles[2].

Market Drivers and Restraints

The growth of the maraviroc market is driven by factors such as the increasing prevalence of HIV, the need for effective antiretroviral therapies, and the favorable toxicity profile of maraviroc. However, the market is restrained by the requirement for tropism testing before initiating maraviroc therapy, which can delay treatment and limit its adoption. Additionally, the emergence of resistance to maraviroc, particularly through the escape of X4-tropic virus, is a significant challenge[3][5].

Market Projections

Future Growth Opportunities

The maraviroc market is expected to see exponential growth due to the increasing demand for antiretroviral therapies and the expanding use of maraviroc in different clinical settings. The market report highlights lucrative opportunities at the country level, with a focus on product pricing, penetration, and market dynamics[2].

Competitive Landscape

The competitive landscape of the maraviroc market is characterized by the presence of several key players. These companies are focusing on product innovation, geographical expansion, and strategic partnerships to maintain their market share. The report provides a cross-analysis of industry verticals and market players, giving a clear picture of the company strategies and market positioning[2].

Clinical and Market Challenges

Tropism Testing

One of the significant challenges in the adoption of maraviroc is the need for tropism testing to determine if the patient's HIV is CCR5-tropic. This requirement can delay treatment initiation and has been identified as a barrier to maraviroc utilization in clinical practice[3].

Resistance and Side Effects

Maraviroc treatment can fail if the virus shifts to X4-tropic or dual/mixed tropic virus. Additionally, common side effects include anaemia, loss of appetite, depression, and rare but severe hypersensitivity reactions. These factors need to be carefully managed to optimize the use of maraviroc[5].

Key Takeaways

• Clinical Trials: Maraviroc is being explored in new clinical settings, including cancer treatment and HIV prevention.
• Efficacy: Maraviroc is effective in treatment-experienced patients with CCR5-tropic virus but limited by the need for tropism testing and the risk of resistance.
• Market Size and Growth: The global maraviroc market is projected to grow significantly, driven by increasing demand and favorable market dynamics.
• Market Drivers and Restraints: The market is driven by the need for effective antiretroviral therapies but restrained by the requirement for tropism testing and the emergence of resistance.
• Future Growth Opportunities: The market is expected to see exponential growth with opportunities in product innovation, geographical expansion, and strategic partnerships.

FAQs

What is Maraviroc and how does it work?

Maraviroc is an antiretroviral drug that prevents HIV from entering uninfected cells by blocking the CCR5 receptor on the surface of immune cells[5].

What are the common side effects of Maraviroc?

Common side effects include anaemia, loss of appetite, depression, difficulty in sleeping, nausea, flatulence, weakness, rash, abdominal pain, and increases in liver enzymes. Rare but severe hypersensitivity reactions can also occur[5].

Why is tropism testing necessary before starting Maraviroc?

Tropism testing is necessary to determine if the patient's HIV is CCR5-tropic, as maraviroc is only effective against this type of virus[3][5].

What is the current market size and growth projection for Maraviroc?

The global maraviroc market was valued at USD 370.1 million in 2023 and is projected to reach USD 750.1 million by 2030, growing at a CAGR of 9.1%[2].

Which companies are the key players in the Maraviroc market?

Key players in the maraviroc market include ViiV Healthcare, SANDOZ, and HETERO[2].

Sources

1. Single-Dose Maraviroc Provides High Drug Levels in All Sites - CROI Conference Abstract
2. Maraviroc Market Size, Share, Trends, Industry Analysis & Forecast - Verified Market Reports
3. Maraviroc Observational Study: The Impact of Expanded Resistance Testing - PMC
4. Clinical Trials Using Maraviroc - National Cancer Institute
5. Maraviroc (Celsentri) - aidsmap