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Cidofovir

Phase 4FDA approved

Cytomegalovirus Retinitis | Small molecule | Infectious Disease |Gilead Sciences, Inc.|Trials Updated: Jun 24, 2005

Cidofovir development status

FDA approval on record Mar 9, 1999 as Vistide
Approval holderGilead Sciences Inc
ApplicationNDA020638
Highest phase Phase 4 run by National Institute of Allergy and Infectious Diseases (NIAID) (NCT00000894)
Phase scored for GILDPhase 2
Registered trials 15 across 4 sponsors since Aug 2001

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials3
Total Enrollment118

FDA Designations

No designations recorded

Cidofovir clinical trials

Cidofovir · 3 trials · 4 indications

Phase 2 1Phase 1 2
NCT00002437The Safety and Effectiveness of Cidofovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDSCytomegalovirus Retinitis
COMPLETED48 Analytics
PHASE2COMPLETED
The Safety and Effectiveness of Cidofovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS
Cytomegalovirus RetinitisUnlock trial analytics

Study Design & Arms

PurposeTREATMENT

Interventions

NameTypeDescription
CidofovirDRUG -
ProbenecidDRUG -
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Eligibility Criteria

Age Range13 Years to 60 Years
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria Concurrent Medication: Allowed: * Antiretroviral agents. * Oral trimethoprim/sulfamethoxazole. * Aerosolized pentamidine. * Dapsone. * Fluconazole. * Rifabutin. * Filgrastim (G-CSF). * p24 vaccine. Patients must have: * Diagnosis of AIDS by CDC criteria. * Diagnosis of periph...

Countries:United StatesUnited KingdomCanada
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Frequently asked questions about Cidofovir

What is Cidofovir used for?

Cidofovir is an investigational small molecule being studied for infectious disease indications including cytomegalovirus retinitis, HIV infections, and herpes simplex. It is developed by Gilead Sciences, Inc. (NASDAQ: GILD). The drug is currently in Phase 2 clinical development for these conditions.

What does Cidofovir target?

Cidofovir is a small molecule antiviral agent. It works by inhibiting viral DNA polymerase, an enzyme essential for viral replication. This mechanism makes it active against DNA viruses including cytomegalovirus, herpes simplex virus, and other related pathogens.

Who makes Cidofovir?

Cidofovir is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol GILD. Gilead is conducting clinical trials to evaluate the drug's safety and efficacy in patients with viral infections.

What phase is Cidofovir in?

Cidofovir is in Phase 2 clinical development. It has completed one Phase 2 trial, NCT00002437, which evaluated the drug for cytomegalovirus retinitis in patients with AIDS. The drug remains investigational and has not been approved by regulatory authorities.

What clinical trials is Cidofovir in?

Cidofovir has completed three clinical trials. NCT00002437 was a Phase 2 study in cytomegalovirus retinitis with 48 participants. NCT00002116 and NCT00002327 were Phase 1 studies in herpes simplex and venereal warts, respectively, with 30 and 40 participants. All trials are completed.

Is Cidofovir the same as HPMPC?

Yes, Cidofovir is also known as HPMPC, which stands for 1-(S)-(3-hydroxy-2-phosphonylmethoxypropyl)cytosine dihydrate. This alternative name appears in clinical trial records, such as NCT00002116, which studied topical HPMPC for refractory mucocutaneous herpes simplex disease.