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Tenofovir

Phase 3

HIV Infections | Small molecule | Infectious Disease |Gilead Sciences, Inc.|Last Updated: May 15, 2012

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
RandomizedDouble-BlindCONTROLLEDDMCBiomarker
Total Trials3
Total Enrollment169
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00573001Evaluation of 4 New Simplified Antiretroviral Treatments in Naive HIV-1 Infected Patients in Africa (ANRS 12115 DAYANA)PHASE3 COMPLETED 120Jul 1, 2008Dec 1, 2011May 15, 20122 Cameroon, Senegal
NCT00561496Pharmacokinetic Study of the Vaginal Microbicide Agent 1% Tenofovir GelPHASE1 COMPLETED 49Mar 1, 2007Apr 1, 2008May 28, 20083 United States, Dominican Republic
NCT00002180A Study of PMPA in HIV-Infected PatientsPHASE1 COMPLETED - - -Jun 24, 20052 United States
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Study Endpoints
Primary Endpoints
Percentage of patients with viral load below 50 copies/mL
week 16
Concentration of tenofovir in local genital tract compartments (intraluminal, mononuclear cells and vaginal tissue levels). Concentration (Cmax) and time of maximum concentration (Tmax) of tenofovir in the systemic compartment.
Single dose; two weeks (after once or twice-daily vaginal administration)
Secondary Endpoints
Percentage of patients with viral Load under 50 copies/ml and under 400 copies/ml
W4, W12, W24, W36, W72, and W96
Severe adverse event onset, metabolic alterations, lipodystrophia
J0, W16, W24, W48, W72, W96
Residual ARV plasmatic concentration
W4, W48
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -
3EXPERIMENTAL -
4ACTIVE_COMPARATOR -
Twice dailyOTHERTenofovir gel intravaginal twice daily for 14 days
Once dailyOTHERTenofovir gel intravaginal once daily for 14 days
Interventions
NameTypeDescription
Tenofovir/Emtricitabine (Truvada) and NevirapineDRUGTenofovir/Emtricitabine(Truvada) 245/200mg 1cp/day ; Nevirapine 200mg 2cp/day after first 14 days
Tenofovir/Emtricitabine/Efavirenz (Atripla)DRUGTenofovir/Emtricitabine/Efavirenz (Atripla) 300/200/600mg 1cp/day
Tenofovir (Viread) and Lopinavir/Ritonavir (Aluvia)DRUGTenofovir (Viread) 300mg 1cp/day ; Lopinavir/Ritonavir (Aluvia) 400/100mg 4cp/day
Tenofovir/Emtricitabine (Truvada) and ZidovudineDRUGTenofovir/Emtricitabine (Truvada) 245/200mg 1cp/day ; Zidovudine 300mg 2cp/day
Tenofovir gelDRUGIntravaginal (4grams)single dose followed by fourteen days
TenofovirDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * age over 18 years for Senegal and over 21 years for Cameroon * HIV-1 infected patient * patient naive from any antiretroviral treatment * CD4 cell count over 50 cells per mm3 * contraceptive method use * informed consent signed Exclusion Criteria: * opportunistic infection o...

Countries:CameroonSenegalUnited StatesDominican Republic
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