Recent Updates
Recently added Catalysts

Maraviroc

Phase 3

HIV Infections | Small molecule | Infectious Disease |GSK plc|Last Updated: Jun 29, 2016

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindCONTROLLEDDMCBiomarker
Total Trials4
Total Enrollment2,163
FDA Designations
No designations recorded
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00426660Expanded Access Program for Maraviroc At Multiple CentersPHASE3 COMPLETED 1,047Feb 1, 2007Jun 1, 2010Jun 29, 2016361 United States, Argentina +24
NCT00098722Trial of Maraviroc (UK-427,857) in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of HIV-1 Infected SubjectsPHASE2 COMPLETED 474Dec 1, 2004Apr 1, 2011May 16, 2012172 United States, Australia +11
NCT00098306Trial of Maraviroc (UK-427,857) in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of HIV-1 Infected SubjectsPHASE2 COMPLETED 601Nov 1, 2004Apr 1, 2011Apr 27, 201222 United States, Canada
NCT00643643Pharmacokinetics, Pharmacodynamics, And Safety Of Maraviroc (UK-427,857) In Patients With Human Immunodeficiency VirusPHASE2 COMPLETED 41Oct 1, 2002Jun 1, 2003Nov 10, 20106 Germany, Netherlands +1
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Percentage of Participants With Grade 3 and Grade 4 Adverse Events (AE)
Baseline up to Week 144

AEs as defined by the Division of AIDS (DAIDS) toxicity grading scale: Grade 3 = severe: interrupted usual daily activity and traditionally required systemic drug therapy or other treatment. Grade 4 = very severe: events that were unacceptable and intolerable or were irreversable or caused imminent danger of death. If same participant had more than 1 occurrence in the same preferred term event category, only the most severe (grade 4) occurrence was taken. Treatment-related = investigator assessment of a reasonable possibility that the investigational product caused or contributed to the AE.

Percentage of Participants With Grade 3 Laboratory Abnormalities Without Regards to Baseline Abnormalities
Baseline up to Week 144

Laboratory abnormalities as defined by the Division of AIDS (DAIDS) toxicity grading scale: Grade 3, Severe =events that interrupted participants usual daily activity and traditionally required systemic drug therapy or other treatment.

Percentage of Participants With Grade 4 Laboratory Abnormalities Without Regards to Baseline Abnormalities
Baseline up to Week 144

Laboratory abnormalities as defined by the Division of AIDS (DAIDS) toxicity grading scale: Grade 4, Very Severe = events which were unacceptable and intolerable or were irreversible or caused the participant to be in imminent danger of death.

Percentage of Participants With Acquired Immunodeficiency Syndrome (AIDS)-Defining Illnesses
Baseline up to Week 144

Treatment-emergent AIDS-defining opportunistic illnesses based on investigator classification guided by a predefined list of clinical Category C adverse events per Center for Disease Control (CDC) HIV Classification System. Includes events occurring up to 30 days after last dose of study drug.

Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Baseline Viral Load
Baseline up to Week 144
Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Baseline/Nadir CD4 Cell Counts
Baseline up to Week 144
Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Time on Therapy
Baseline up to Week 144
Percentage of Participants With All Causality Treatment-emergent Adverse (AEs) Events by Gender
Baseline up to Week 144

Treatment-emergent AEs by gender that occurred up to 30 days after the last dose of study medication.

Percentage of Participants With Treatment-emergent Adverse Events (AEs) by Race
Baseline up to Week 144

Treatment-emergent AEs by race that occurred up to 30 days after the last dose of study medication.

Percentage of Participants With Treatment-emergent Adverse Events (AEs) by Age
Baseline up to Week 144

Treatment-emergent AEs by age that occurred up to 30 days after the last dose of study medication.

Percentage of Participants With Treatment-emergent Averse Events (AEs) by Baseline Hepatitis B and Hepatitis C Virus Serology Status
Baseline up to Week 144

Treatment emergent AEs by hepatis B and hepatitis C serology status that occurred up to 30 days post last dose.

Log 10-transformed Human Immunodeficiency Virus Ribonucleic Acid (HIV-1 RNA) Levels at Baseline
Baseline

Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.

Change From Baseline in Log 10-transformed HIV-1 RNA Levels at Week 24
Baseline and Week 24

Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log10 copies/mL). Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.

Change From Baseline in Log 10-transformed HIV-1 RNA Levels at Week 48
Baseline and Week 48

Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log10 copies/mL). Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.

Change from baseline in viral load
Day 11
Pharmacokinetic profile of UK-427,857
Days 1 and 10
Receptor saturation
Days 1, 5, 10, 11, 13, 15, 19, 40
Secondary Endpoints
Percentage of Participants With ≥0.5 log10 Reduction From Baseline in Human Immunodeficiency Virus 1 Ribonucleic Acid (HIV 1 RNA)
Baseline up to Week 144
Percentage of Participants With ≥1.0 log10 Reduction From Baseline in HIV 1 RNA
Baseline up to Week 144
Percentage of Participants With HIV-1 RNA Levels Below the Limit of Quantification: <400 Copies/mL
Baseline up to Week 144
Unlock Study Endpoints
Study Design & Arms
AllocationNON_RANDOMIZED
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2PLACEBO_COMPARATOR -
3EXPERIMENTAL -
AEXPERIMENTAL -
BEXPERIMENTAL -
CEXPERIMENTAL -
DEXPERIMENTAL -
EPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
maravirocDRUGThe nominal dose for maraviroc is 300 mg twice a day (BID). However, the dosage of maraviroc should be adjusted based on optimal background therapy (OBT) patient is taking. If OBT includes CYP3A4 inhibitor (with or without inducers) maraviroc dose should be 150 mg BID and if OBT includes CYP3A4 inducer (without inhibitors) maraviroc dose should be 600mg BID. If OBT does not include any CYP3A4 inducers or inhibitors maraviroc dose should be 300 mg BID.
Maraviroc (UK-427,857)DRUGmaraviroc (UK-427,857) 150 mg taken once daily, OBT + maraviroc (UK-427,857) 150 mg taken twice daily, or OBT alone.
optimized background therapyDRUG\[OBT (3-6 drugs based on treatment history and resistance testing)\]
PlaceboDRUGPatients 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.
Unlock Study Design Details
Eligibility Criteria
Age Range16 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites361

Inclusion Criteria: * Subjects must be failing to achieve adequate virologic suppression on their current regimen and have HIV-1 RNA greater than or equal to 1000 copies/ml, at screening * Have only R5 HIV-1 at Screening as verified by the Monogram Biosciences Trofile assay * Minimum age must be 16...

Countries:United StatesArgentinaAustraliaAustriaBelgiumCanadaChileCosta RicaDominican RepublicFranceGermanyGreeceHong KongIndiaIrelandItalyMalaysiaMexicoNetherlandsPortugalPuerto RicoRomaniaSpainSwitzerlandTaiwanUnited KingdomPolandSweden
Unlock Eligibility Criteria