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Tenofovir

Phase 1

HIV Infections | Small molecule | Infectious Disease |Gilead Sciences, Inc.|Last Updated: May 28, 2008

Success Probability

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Market & Valuation

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Trial Design

Double-BlindCONTROLLEDBiomarker
Total Trials2
Total Enrollment49

FDA Designations

No designations recorded

Clinical trial landscape

Tenofovir · 2 trials · 1 indication

Phase 1 2
NCT00561496Pharmacokinetic Study of the Vaginal Microbicide Agent 1% Tenofovir GelHIV Infections
COMPLETED49 Analytics
NCT00002180A Study of PMPA in HIV-Infected PatientsHIV Infections
COMPLETED- Analytics
PHASE1COMPLETED
Pharmacokinetic Study of the Vaginal Microbicide Agent 1% Tenofovir Gel
HIV InfectionsUnlock trial analytics
PHASE1COMPLETED
A Study of PMPA in HIV-Infected Patients
HIV InfectionsUnlock trial analytics

Study Endpoints

Primary Endpoints

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)
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Twice dailyOTHERTenofovir gel intravaginal twice daily for 14 days
Once dailyOTHERTenofovir gel intravaginal once daily for 14 days

Interventions

NameTypeDescription
Tenofovir gelDRUGIntravaginal (4grams)single dose followed by fourteen days
TenofovirDRUG -
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Eligibility Criteria

Age Range18 Years to 45 Years
SexFEMALE
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * Must be between 18-45 years old, inclusive * Must be in general good health by volunteer history without any clinically significant systemic disease (including liver disease/hepatitis, gastrointestinal disease, kidney disease, thyroid disease, osteoporosis or bone disease) * M...

Countries:United StatesDominican Republic
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Frequently asked questions about Tenofovir

What is Tenofovir used for in HIV Infections?

Tenofovir is a small molecule being developed by Gilead Sciences, Inc. for the treatment of HIV Infections. It is currently in Phase 1 clinical development, meaning it is investigational and has not yet been approved for use. The drug is being studied in clinical trials to evaluate its safety and pharmacokinetics in HIV-infected patients.

What does Tenofovir target?

Tenofovir is a small molecule drug being developed for HIV Infections. As a small molecule, it is designed to interfere with viral replication. However, the specific molecular target or target class has not been specified in the available information. The drug is currently in Phase 1 clinical trials to assess its safety and how it is processed by the body.

Who makes Tenofovir?

Tenofovir is being developed by Gilead Sciences, Inc., a biopharmaceutical company listed on the NASDAQ under the ticker symbol GILD. The company is conducting clinical trials to evaluate the drug for the treatment of HIV Infections. Tenofovir is currently in Phase 1 development, indicating it is still in the early stages of clinical testing.

What phase is Tenofovir in?

Tenofovir is currently in Phase 1 clinical development. It is an investigational drug being studied for the treatment of HIV Infections. The drug has completed two Phase 1 trials, with a total enrollment of 49 participants. Tenofovir is not yet approved by regulatory authorities and remains in the early stages of clinical testing.

What clinical trials is Tenofovir in?

Tenofovir has been studied in two completed Phase 1 clinical trials. The first trial, NCT00002180, was a study of PMPA in HIV-infected patients in the United States. The second trial, NCT00561496, was a pharmacokinetic study of a vaginal microbicide gel containing 1% tenofovir, conducted in the United States and Dominican Republic with 49 female participants.

Is Tenofovir the same as PMPA?

Tenofovir is also known as PMPA, as indicated by the clinical trial NCT00002180, which was titled 'A Study of PMPA in HIV-Infected Patients'. This trial was a Phase 1 study conducted in the United States to evaluate the drug in HIV-infected patients. Tenofovir is being developed by Gilead Sciences, Inc. for the treatment of HIV Infections.