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AMD11070

Phase 1

HIV Infections | Small molecule | Infectious Disease |Sanofi|Last Updated: Feb 11, 2014

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment10
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00361101A Study of AMD11070 in HIV-infected Patients Carrying X4-tropic VirusPHASE1 COMPLETED 10 — — Oct 1, 2005Apr 1, 2010Feb 11, 20142 United States, United Kingdom
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Study Endpoints
Primary Endpoints
safety and antiviral activity of AMD11070 administered in HIV-infected patients who harbor-X4-tropic virus.
10 days
the proportion of patients per cohort who have a ≥1 log10 rlu reduction in X4-tropic virus and to describe changes from baseline to Day 10 in log10 rlu corresponding to X4-tropic virus.
10 days
Secondary Endpoints
the relationship between standard pharmacokinetic (PK) measures, viral response, and a shift in T-cell receptor tropism.
10 days
the relationship of coreceptor tropism phenotype to CD4+ count, viral load, and drug resistance in the screening patient population.
10 days
the virologic activity of AMD11070 at day 10 of study treatment by analyzing the proportion of patients with Plasma HIV-1 RNA levels <400 and <50 copies/ml and the proportion with a >1 log10 decline in plasma HIV from baseline.
10 days
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
AMD11070DRUG200 mg PO BID (by mouth two times per day) for 10 days.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * HIV-1 infection, as documented by any licensed ELISA test kit (confirmed by Western Blot), HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, cDNA, or a second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test. * Both antiretroviral trea...

Countries:United StatesUnited Kingdom
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