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Adefovir

Phase 1

HIV Infections | Small molecule | Infectious Disease |Gilead Sciences, Inc.|Last Updated: Jun 24, 2005

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 Trials2
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00002115A Phase I/II Study of the Safety, Tolerance, and Pharmacokinetics of 9-(2-Phosphonylmethoxyethyl)Adenine ( PMEA; Adefovir ) in Patients With Advanced HIV Disease.PHASE1 COMPLETED 20 - -Jun 24, 20051 United States
NCT00002326The Safety and Effectiveness of Zidovudine Plus Adefovir in HIV-Infected PatientsPHASE1 COMPLETED 20 - -Jun 24, 20051 United States
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Study Design & Arms
PurposeTREATMENT
Interventions
NameTypeDescription
AdefovirDRUG -
ZidovudineDRUG -
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria Concurrent Medication: Allowed: * Other antiretroviral therapy IF on a stable dose for at least 4 weeks prior to study entry. * Prophylactic therapy with aerosolized pentamidine, oral trimethoprim/sulfamethoxazole (Bactrim, Septra) or dapsone, and fluconazole or ketoconazole IF...

Countries:United States
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