DeepMed Research

Adefovir dipivoxil

Generic Name: Adefovir dipivoxil

Brand Names: Hepsera

Drug Type: Small Molecule

Chemical Formula: C_₂₀H_₃₂N_₅O_₈P

CAS Number: 142340-99-6

Unique Ingredient Identifier: U6Q8Z01514

Background: Adefovir dipivoxil, previously called bis-POM PMEA, with trade names Preveon and Hepsera, is an orally-administered acyclic nucleotide analog reverse transcriptase inhibitor (ntRTI) used for treatment of hepatitis B. It is ineffective against HIV-1. Adefovir dipivoxil is the diester prodrug of adefovir.

Indication: Indicated for the treatment of chronic hepatitis B in adult patients with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease; this is based on histological, virological, biochemical, and serological responses in adult patients with HBeAg+ and HBeAg- chronic hepatitis B with compensated liver function, and in adult patients with clinical evidence of lamivudine-resistant hepatitis B virus with either compensated or decompensated liver function.

Associated Conditions: Chronic Hepatitis B Infection

Clinical Trials

A Phase II, Stratified, Randomized, Double-Blind, Multi-Center Study of the Safety and Efficacy of Adefovir Dipivoxil (ADF) at Two Dose Levels in Triple Combination Therapies With Protease Inhibitors (PI) and Nucleoside Reverse Transcriptase Inhibitors (RTI) for the Treatment of HIV-Infected Patient

Phase 2

Completed

Conditions: HIV Infections

First Posted Date: 2001-08-31

Last Posted Date: 2005-06-24

Lead Sponsor: Gilead Sciences

Target Recruit Count: 120

Registration Number: NCT00002184

Locations: 🇺🇸
Krauss Med Partners / Dept of Research and Development, Los Angeles, California, United States
🇺🇸
UCLA Care Ctr, Los Angeles, California, United States
🇵🇷
Hosp Regional de Ponce - Area Vieja, Ponce, Puerto Rico

and more 12 locations

Safety and Effectiveness of Giving Adefovir Dipivoxil Plus Abacavir Plus Efavirenz Plus Amprenavir to HIV-Infected Patients Who Have Failed to Respond to Previous Protease Inhibitor Treatment

Phase 2

Completed

Conditions: HIV Infections

First Posted Date: 2001-08-31

Last Posted Date: 2005-06-24

Lead Sponsor: Gilead Sciences

Target Recruit Count: 25

Registration Number: NCT00002419

Locations: 🇺🇸
Brown Univ School of Medicine, Providence, Rhode Island, United States
🇺🇸
AIDS Research Consortium of Atlanta, Atlanta, Georgia, United States
🇺🇸
Pacific Oaks Med Group, Beverly Hills, California, United States

and more 2 locations

The Safety and Effectiveness of Bis-POM PMEA in HIV-Infected Patients

Phase 1

Completed

Conditions: HIV Infections

First Posted Date: 2001-08-31

Last Posted Date: 2005-06-24

Lead Sponsor: Gilead Sciences

Target Recruit Count: 36

Registration Number: NCT00002346

Locations: 🇺🇸
Johns Hopkins Univ, Baltimore, Maryland, United States

The Safety and Effectiveness of Adefovir Dipivoxil Plus Indinavir Combined With Zidovudine or Lamivudine or Stavudine in HIV-Infected Patients Who Have Not Taken Anti-HIV Drugs

Phase 2

Completed

Conditions: HIV Infections

First Posted Date: 2001-08-31

Last Posted Date: 2005-06-24

Lead Sponsor: Gilead Sciences

Target Recruit Count: 100

Registration Number: NCT00002379

Locations: 🇺🇸
Phoenix Body Positive, Phoenix, Arizona, United States
🇺🇸
Saint Vincent's AIDS Ctr, New York, New York, United States
🇺🇸
George Washington Med Ctr, Washington, District of Columbia, United States

and more 12 locations

Safety and Effectiveness of Adding Adefovir Dipivoxil and Nelfinavir to the Anti-HIV Therapy of HIV-Infected Children

Phase 2

Conditions: HIV Infections

First Posted Date: 2001-08-31

Last Posted Date: 2005-06-24

Lead Sponsor: Gilead Sciences

Target Recruit Count: 36

Registration Number: NCT00002219

Locations: 🇺🇸
Bronx Lebanon Hosp Ctr / Dept of Pediatrics, Bronx, New York, United States
🇺🇸
St Lukes Roosevelt Hosp Ctr, New York, New York, United States
🇺🇸
Tulane Univ Med Ctr / Dept of Pediatrics, New Orleans, Louisiana, United States

and more 4 locations

The Safety and Effectiveness of Adefovir Dipivoxil in HIV-Infected Children

Phase 1

Completed

Conditions: HIV Infections

First Posted Date: 2001-08-31

Last Posted Date: 2005-06-24

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 24

Registration Number: NCT00000843

Locations: 🇺🇸
UCSF / Moffitt Hosp - Pediatric, San Francisco, California, United States
🇺🇸
Vanderbilt Univ Med Ctr, Nashville, Tennessee, United States
🇺🇸
Chicago Children's Memorial Hosp, Chicago, Illinois, United States

and more 7 locations

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Adefovir Dipivoxil When Added to Standard Antiretroviral Therapy for the Treatment of HIV-Infected Patients With CD4 Cell Counts >= 200/mm3

Not Applicable

Completed

Conditions: HIV Infections

First Posted Date: 2001-08-31

Last Posted Date: 2005-06-24

Lead Sponsor: Gilead Sciences

Target Recruit Count: 400

Registration Number: NCT00002161

Locations: 🇺🇸
AIDS Research Consortium of Atlanta, Atlanta, Georgia, United States
🇺🇸
East Bay AIDS Ctr, Berkeley, California, United States
🇺🇸
Chicago Ctr for Clinical Research, Chicago, Illinois, United States

and more 24 locations

Safety and Effectiveness of Giving Adefovir (Preveon) Plus Other Anti-HIV Drugs to HIV-Infected Patients Who Have Not Responded to Other Anti-HIV Drug Combinations

Not Applicable

Completed

Conditions: HIV Infections

First Posted Date: 2001-08-31

Last Posted Date: 2005-06-24

Lead Sponsor: Gilead Sciences

Registration Number: NCT00002398

Locations: 🇺🇸
Gilead Sciences Inc, Foster City, California, United States

Phase I Study of the Safety, Tolerance, and Pharmacokinetics of 9-[2-(Bispivaloyloxymethyl)Phosphonylmethoxyethyl]Adenine (Bis-POM PMEA; Adefovir Dipivoxil) in HIV-Infected Patients

Phase 1

Completed

Conditions: HIV Infections

First Posted Date: 2001-08-31

Last Posted Date: 2005-06-24

Lead Sponsor: Gilead Sciences

Target Recruit Count: 15

Registration Number: NCT00002128

Locations: 🇺🇸
Johns Hopkins Univ, Baltimore, Maryland, United States

A Study of Adefovir Dipivoxil in HIV-Infected Patients Who Have Not Been Treated With Anti-HIV Drugs

Phase 1

Completed

Conditions: HIV Infections

First Posted Date: 2001-08-31

Last Posted Date: 2005-06-24

Lead Sponsor: Gilead Sciences

Target Recruit Count: 45

Registration Number: NCT00002206

Locations: 🇺🇸
Anderson Clinical Research, Philadelphia, Pennsylvania, United States
🇺🇸
Johns Hopkins Univ Clinical Pharmacology, Baltimore, Maryland, United States
🇺🇸
Anderson Clinical Research / Inc, Pittsburgh, Pennsylvania, United States

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