MedPath

Adefovir dipivoxil

Generic Name
Adefovir dipivoxil
Brand Names
Hepsera
Drug Type
Small Molecule
Chemical Formula
C20H32N5O8P
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

Continued Access Study of Adefovir Dipivoxil (ADV) for Patients w/Chronic HBV Infection.

Not Applicable
Terminated
Conditions
Hepatitis B
First Posted Date
2005-09-12
Last Posted Date
2007-03-08
Lead Sponsor
Gilead Sciences
Target Recruit Count
400
Registration Number
NCT00158704

Telbivudine Versus Adefovir Dipivoxil in Adults With HBegAg-Positive, Compensated Chronic Hepatitis B

Phase 3
Completed
Conditions
Chronic Hepatitis B
First Posted Date
2005-06-22
Last Posted Date
2015-05-12
Lead Sponsor
Novartis
Registration Number
NCT00115245

Treatment of Hepatitis in Patients Who Are Triple-Infected With HIV, Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV)

Phase 2
Withdrawn
Conditions
Hepatitis C
Hepatitis B
HIV Infections
First Posted Date
2003-01-06
Last Posted Date
2021-11-01
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Registration Number
NCT00051077

An Open-Label Program of Adefovir Dipivoxil in the Treatment of Patients With Lamivudine-Resistant Chronic Hepatitis B With Limited Treatment Options

Conditions
Chronic Hepatitis B
First Posted Date
2002-08-01
Last Posted Date
2014-01-07
Lead Sponsor
Gilead Sciences
Registration Number
NCT00042393

A Comparison of Adefovir and Tenofovir for the Treatment of Lamivudine-Resistant Hepatitis B Virus in People With HIV

Phase 2
Completed
Conditions
HIV Infections
Hepatitis B
First Posted Date
2002-04-09
Last Posted Date
2021-11-01
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
90
Registration Number
NCT00033163
Locations
🇺🇸

Northwestern University CRS, Chicago, Illinois, United States

🇺🇸

Johns Hopkins Adult AIDS CRS, Baltimore, Maryland, United States

🇺🇸

Univ. of Cincinnati CRS, Cincinnati, Ohio, United States

and more 12 locations

A Study on Amprenavir in Combination With Other Anti-HIV Drugs in HIV-Positive Patients

Phase 2
Completed
Conditions
HIV Infections
First Posted Date
2001-08-31
Last Posted Date
2021-10-29
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
475
Registration Number
NCT00000912
Locations
🇺🇸

USC Univ Hosp & Ambulatory Hlth Care Ctr / USC Med Ctr, Los Angeles, California, United States

🇺🇸

Emory Univ, Atlanta, Georgia, United States

🇺🇸

UCLA CARE Ctr, Los Angeles, California, United States

and more 42 locations

The Safety and Effectiveness of Adefovir Dipivoxil in the Treatment of HIV-Infected Patients

Phase 3
Completed
Conditions
Cytomegalovirus Infections
HIV Infections
Interventions
First Posted Date
2001-08-31
Last Posted Date
2013-10-01
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
505
Registration Number
NCT00001082
Locations
🇺🇸

North Jersey Community Research Initiative, Newark, New Jersey, United States

🇺🇸

Community Consortium / UCSF, San Francisco, California, United States

🇺🇸

Washington Reg AIDS Prog / Dept of Infect Dis, Washington, District of Columbia, United States

and more 12 locations

Treatment Success and Failure in HIV-Infected Subjects Receiving Indinavir in Combination With Nucleoside Analogs: A Rollover Study for ACTG 320

Phase 2
Completed
Conditions
HIV Infections
First Posted Date
2001-08-31
Last Posted Date
2021-10-28
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
440
Registration Number
NCT00000885
Locations
🇺🇸

Johns Hopkins Hosp, Baltimore, Maryland, United States

🇺🇸

Division of Inf Diseases/ Indiana Univ Hosp, Indianapolis, Indiana, United States

🇺🇸

Boston Med Ctr, Boston, Massachusetts, United States

and more 50 locations

The Effectiveness of Nelfinavir and Efavirenz, Used Alone or Together, Combined With Other Anti-HIV Drugs in Patients Who Have Taken Anti-HIV Drugs

Phase 2
Completed
Conditions
HIV Infections
First Posted Date
2001-08-31
Last Posted Date
2021-11-01
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
300
Registration Number
NCT00001087
Locations
🇺🇸

Rush Univ. Med. Ctr. ACTG CRS, Chicago, Illinois, United States

🇺🇸

Cook County Hosp. CORE Ctr., Chicago, Illinois, United States

🇺🇸

Johns Hopkins Adult AIDS CRS, Baltimore, Maryland, United States

and more 3 locations

Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients

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
NCT00002234
Locations
🇺🇸

Pacific Oaks Med Group, Beverly Hills, California, United States

🇺🇸

Univ of Colorado / Health Science Ctr, Denver, Colorado, United States

🇺🇸

AIDS Research Consortium of Atlanta, Atlanta, Georgia, United States

and more 2 locations
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