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darunavir; ritonavir; emtricitabine/tenofovir

Phase 3

HIV-1 Infections | Small molecule | Infectious Disease |Gilead Sciences, Inc.|Last Updated: Feb 5, 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
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment90
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01033760Optimisation of Primary HIV1 Infection Treatment(ANRS 147 OPTIPRIM)PHASE3 COMPLETED 90Apr 1, 2010Dec 1, 2013Feb 5, 20141 France
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Study Endpoints
Primary Endpoints
To compare the 24-month impact of maximized vs. conventional HAART- on HIV reservoirs, as assessed by cell-associated HIV-DNA levels, in patients with acute or primary HIV-1 infection
24 months
Secondary Endpoints
Plasma HIV-RNA levels and proportion of patients with plasma viral load < 50 copies/ml at M12, M24 and M30
30 months
Plasma HIV-RNA levels and proportion of patients with plasma viral load < 5 copies/ml at M24
24 months
Changes in cell-associated HIV-DNA between baseline and M24
24 Months
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
arm 1EXPERIMENTALdarunavir, ritonavir, emtricitabine/tenofovir, maraviroc, raltegravir
arm 2ACTIVE_COMPARATORdarunavir, ritonavir, emtricitabine/tenofovir
Interventions
NameTypeDescription
raltegravir; maraviroc; darunavir; ritonavir; tenofovir/emtricitabineDRUGraltegravir (Isentress®): 400 mg bid. maraviroc (Celsentri®): 150 mg bid. darunavir (Prezista®): 800 mg QD. ritonavir tablet (Norvir®): 100 mg QD. tenofovir/emtricitabine (Truvada®): one 245/200 mg tablet QD.
darunavir; ritonavir; emtricitabine/tenofovirDRUGdarunavir (Prezista®): 800 mg QD. ritonavir tablet (Norvir®): 100 mg QD. tenofovir/emtricitabine (Truvada®): one 245/200 mg tablet QD.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patients with acute or primary HIV-1 infection * Acute infection: negative or slightly positive Elisa, with negative or incomplete western-blot (0 or 1 antibody) and positive HIV-RNA and/or positive Ag p24. * Primary infection: positive Elisa with incomplete Western-blot (≥ 2 ...

Countries:France
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