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.
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.
NCT00098748 ↗	Trial of Maraviroc (UK-427,857) in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of Antiretroviral-Experienced NonCCR5-Tropic HIV-1 Infected Subjects	Completed	Pfizer	Phase 2/Phase 3	2004-11-01	Maraviroc (UK-427,857), a selective and reversible CCR5 co-receptor 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 in the United States, maraviroc (UK-427,857) is approved for use as part of combination antiretroviral treatment in treatment-experienced and treatment-naive adult subjects. At least 50% of treatment-experienced patients are infected with R5-tropic HIV-1 exclusively. However, even in patients infected with a dual tropic (R5 + X4) phenotype, a large proportion of the virus population still uses CCR5 exclusively. Thus, the purpose of this study is to evaluate the antiretroviral activity, and safety, of maraviroc (UK-427,857) (in combination with other agents) in HIV infected, treatment experienced patients who are failing their current antiretroviral regimen and not infected with R5-tropic virus exclusively. This study will involve more than 200 centers globally to achieve a total randomized subject population of 192 subjects. Patients will be randomly (1:1:1) 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. Randomization was stratified by Enfuvirtide use in OBT (yes/no) and Screening HIV-1 RNA level (viral load) (

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
Texas	21
Pennsylvania	21
North Carolina	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

Last updated: July 28, 2026

Maraviroc clinical trials update, market analysis and forecast (2026)

Executive summary: Maraviroc remains a niche, largely supply-chain and label-limitation driven product in the US and major EU markets after the HIV-treatment paradigm shifted toward modern INSTI-based regimens. Commercial performance is constrained by (1) declining regimen positioning, (2) limited clinical adoption due to tropism testing requirements, (3) generic and low-cost NRTI/INSTI/boosted-PI competition, and (4) regulatory/label stability that does not materially expand use. A clean, decision-grade forecast requires up-to-date trial and sales/forecast inputs that are not provided here; absent those inputs, no complete, accurate market projection can be produced.

What is the latest clinical trials update for maraviroc in 2026?

Featured snippet answer: No decision-grade “latest” global clinical-trials status for maraviroc can be stated from the information available in this request.

Which clinical trial types are typically relevant for maraviroc right now?

Maraviroc’s contemporary trial relevance historically falls into four buckets:

• Optimized combinations with INSTIs/NRTIs to improve time-to-suppression and resistance outcomes in real-world settings.
• Adherence and implementation studies addressing tropism-testing workflows (e.g., baseline assay access and turnaround).
• Resistance and pharmacology work focused on CCR5-tropism dynamics, viral resistance pathways, and adherence-driven failure.
• Safety/tolerability follow-up evaluating hepatotoxicity risk, psychiatric events, and drug-drug interaction management with metabolized co-therapies.

Where do most new maraviroc studies typically fail to scale?

• Enrollment friction: requiring confirmed CCR5-tropic eligibility.
• Therapy competition: INSTI-based standards of care reduce demand for CCR5 antagonists.
• Regulatory signaling: no clear pathway to broaden label indications absent compelling new efficacy.

What market is maraviroc sold in, and how big is it?

Featured snippet answer: No complete market sizing can be provided from this request.

Commercial drivers

• CCR5-tropism testing dependency constrains physician use to settings with accessible assays and workflow readiness.
• Drug-drug interaction complexity limits patient eligibility compared with lower-interaction regimens.
• Prescriber habit shift toward once-daily INSTI-based regimens reduces “new starts.”

Commercial constraints

• Niche penetration: Maraviroc historically behaves like a specialist product rather than a first-line backbone.
• Exclusivity economics: Without a clear pathway to new high-volume indications, revenue typically remains constrained.

When does maraviroc lose exclusivity, and what does that mean for generics?

Featured snippet answer: A precise exclusivity loss timeline cannot be stated from the information provided in this request.

What exclusivity usually matters for maraviroc

• US regulatory exclusivity: listed patents or formulation/process patents that control generic entry
• EU/UK: supplementary protection certificate and marketed-product patent estates
• Orange Book status: patent-by-patent barriers to Paragraph IV filings and tentative approvals

What generic entry risks exist for maraviroc

• If formulation and process patents have lapsed: generic entry tends to be rapid after regulatory readiness.
• If drug substance synthesis or polymorph/formulation patents remain: entry can be delayed or require design-around.

What patents protect maraviroc, and how strong is the patent estate?

Featured snippet answer: A complete, accurate patent-landscape assessment cannot be produced from this request because no patent identifiers, jurisdictions, or regulatory reference points are included.

Patent clusters that typically matter

• Drug substance synthesis
• Compositions and formulations (tablet strengths, excipient systems, dissolution profiles)
• Manufacturing processes
• Method-of-use claims tied to CCR5-tropism stratification and combinations

How patent strength usually maps to commercial risk

• If remaining patents are composition of matter or formulation, generic conversion is slower and litigation more likely.
• If remaining protections are method-of-use, generic entry often proceeds with label carve-outs unless those claims are broader and enforceable.

What is the Orange Book status of maraviroc and which patents block generic entry?

Featured snippet answer: Orange Book status and patent-blocking details cannot be listed from the information provided in this request.

What you would normally check (for a decision-grade entry risk)

• Active US patents listed for each dosage form/strength
• Patent expiration dates by jurisdiction
• Whether patents are Hatch-Waxman blocking vs. carve-out for formulation changes
• Whether ANDA filers have filed Paragraph IV certifications

How does maraviroc compare with modern HIV regimens (INSTI-based therapy)?

Featured snippet answer: Maraviroc competes in a reduced-growth niche because INSTI-based regimens have largely become the standard backbone, limiting the addressable population for CCR5 antagonism.

Clinical positioning contrasts

• Maraviroc: requires CCR5-tropism confirmation and has complex interaction management.
• INSTI regimens: typically broader eligibility and simpler management in routine practice.

Commercial implication

• A CCR5 antagonist faces limited “new start” share unless a subgroup shows clear regimen advantage or label expansion occurs.

What formulations are protected by maraviroc patents (tablet strengths, composition, manufacturing)?

Featured snippet answer: A formulations-protection map cannot be produced from the information provided in this request.

Formulation risk factors for generics

• Dissolution profile targets and excipient selection
• Stability and impurity profiles tied to manufacturing processes
• Potential polymorph control and solid-state specifications

What formulation and manufacturing IP barriers affect generic entry for maraviroc?

Featured snippet answer: Specific manufacturing IP barriers cannot be identified from this request.

Typical barriers

• Controlled processes for impurity management
• Solid-state form claims
• Scale-up parameters tied to yield and quality attributes

What patent litigation affects maraviroc, including Paragraph IV and settlements?

Featured snippet answer: Litigation events, docket outcomes, and settlement terms cannot be enumerated from the information provided in this request.

What litigation would matter for a forecast

• Injunction timelines
• Entry dates carved by settlement
• License scope by product strength and geography

Is maraviroc facing biosimilar risk, and how would that work?

Featured snippet answer: Biosimilar risk is not applicable to maraviroc because it is a small-molecule drug, not a biologic.

What replaces biosimilar risk for small molecules

• Generic/authorized generic entry
• Label carve-outs and patent challenges under Hatch-Waxman

Global market projection for maraviroc: base case, downside, and upside

Featured snippet answer: No complete global projection can be stated from the information provided in this request.

Projection mechanics that typically drive maraviroc forecasts

• Patient cohort dynamics: aging treated populations, regimen switching rates, and tropism-testing availability.
• Pricing and competition: generic erosion rates and tender pressure (EU).
• Regulatory and payer policy: formularies and prior authorization requirements.
• Supply continuity: procurement reliability and manufacturer footprint.

What would justify an upside case (in general)

• Evidence or label change expanding beyond CCR5-tropism dependent use
• Strong real-world outcomes supporting conversion from INSTI backbones in specific subgroups

What drives downside

• Continued de-emphasis in clinical guidelines and formularies
• Faster generic conversion and price compression without offsetting demand

Key Takeaways

• Maraviroc’s market opportunity is constrained by regimen paradigm shift toward INSTI-based HIV therapy and by CCR5-tropism testing and interaction-management requirements.
• A decision-grade clinical trials update and market projection for 2026 cannot be produced from the information supplied in this request.
• Generics and patent expiration dynamics typically dominate near-term commercial outlook for older small molecules like maraviroc, but specific dates, Orange Book listings, and litigation status are not available here.

FAQs

1. Does maraviroc have any current FDA labeling expansion that increases its addressable population?
2. How does tropism testing availability affect real-world maraviroc prescribing and persistence?
3. What are the key drug-drug interaction risks that limit maraviroc eligibility versus INSTIs?
4. What patent and ANDA pathways historically control generic entry for older HIV small molecules like maraviroc?
5. How do EU formularies and tender cycles influence maraviroc pricing and demand?

References

1. No sources were provided in the request.