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maraviroc

Phase 2

HIV-1 Infection | Small molecule | Infectious Disease |Pfizer, Inc.|Last Updated: Sep 5, 2014

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment25

FDA Designations

No designations recorded

Clinical trial landscape

maraviroc · 1 trial · 2 indications

Phase 2 1
NCT00993148Maraviroc Plus Darunavir/Ritonavir for Treatment-Naïve Patients Infected With R5-tropic HIV-1HIV-1 Infection
COMPLETED25 Analytics
PHASE2COMPLETED
Maraviroc Plus Darunavir/Ritonavir for Treatment-Naïve Patients Infected With R5-tropic HIV-1
HIV-1 InfectionUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants With Plasma HIV-1 RNA >50
24 weeks

Percentage of participants with confirmed plasma HIV-1 RNA \> 50 copies/mL

Secondary Endpoints

Percentage of Participants With Virologic Failure or Off Study Treatment Regimen
24 weeks
Percentage of Participants With Plasma HIV-1 RNA >50 Copies/mL
48 weeks
Signs/Symptoms or Laboratory Toxicities of Grade 3 or Higher
96 weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Maraviroc plus darunavir/ritonavirEXPERIMENTALSingle arm open label trial of maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily for 96 weeks

Interventions

NameTypeDescription
maravirocDRUG150 mg tab by mouth once daily for 96 weeks
darunavirDRUG800 mg tab by mouth once daily for 96 weeks
ritonavirDRUG100 mg capsule by mouth once daily for 96 weeks
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * HIV-1 infection, as documented by any licensed HIV test kit and confirmed by Western blot, HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA any time prior to study entry * Plasma HIV-1 RNA 5, 000 to 500,000 copies/mL obtain...

Countries:United States
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Frequently asked questions about maraviroc

What is maraviroc used for in HIV-1 infection?

Maraviroc is a small molecule being studied for the treatment of HIV-1 infection. It is currently in Phase 2 clinical development as an investigational therapy. The drug is being evaluated in combination with other antiretroviral agents for patients with R5-tropic HIV-1.

Who makes maraviroc?

Maraviroc is being developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with HIV-1 infection.

What phase is maraviroc in?

Maraviroc is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied in a completed Phase 2 trial for the treatment of HIV-1 infection.

What clinical trials is maraviroc in?

Maraviroc has been studied in one completed clinical trial, identified as NCT00993148. This Phase 2 trial evaluated maraviroc in combination with darunavir and ritonavir for treatment-naïve patients infected with R5-tropic HIV-1. The trial enrolled 25 participants in the United States.

Is maraviroc the same as other HIV drugs?

Maraviroc is a distinct investigational drug being developed by Pfizer. It is being studied specifically for HIV-1 infection and is not known to be the same as any other approved medication. Its mechanism of action and clinical profile are unique among antiretroviral therapies.