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

Completed · Phase 2

Conditions studied: HIV Infections, Hepatitis B

In brief

Control of hepatitis B virus (HBV) infection can be difficult in HIV infected people who have taken the antiviral lamivudine (3TC). These people may have HBV that has become resistant to 3TC. Adefovir dipivoxil (ADV) has shown promising anti-HBV activity in clinical trials; tenofovir disoproxil fumarate (TDF) is used to treat HIV and may also be effective against HBV. The purpose of this study is to find out if adding ADV or TDF to a highly active antiretroviral therapy (HAART) regimen that includes 3TC has an effect on HBV infection in patients coinfected with HIV and HBV. The tolerability and safety of these drugs will be examined.

Key facts

Study ID

NCT00033163

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

90

Expected to finish

2005-05-01

Last updated by the study team

2021-11-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Serious kidney problems within the last 12 months
• Allergic or sensitive to ADV or TDF
• Active hepatitis C virus (HCV) disease or unknown HCV status within 24 weeks of study entry
• Any medical or mental illness that, in the opinion of the investigator, would interfere with the protocol
• Past or current alcohol or drug abuse that would affect the protocol
• Malignancy that, in the opinion of the investigator, would make the patient unsuitable for the study
• Certain anti-HBV drugs within 90 days of study entry or expected use of these agents during the course of the study
• Drugs that may damage the kidneys within 8 weeks prior to study screening or expected use of these agents during the course of the study
• Systemic corticosteroids within 90 days of study entry
• Current use of drugs containing pivalic acid
• Certain investigational anti-HIV agents
• Pregnant or breastfeeding

Where it is running

• UC Davis Medical Center — Sacramento, California, United States
• Univ. of California Davis Med. Ctr., ACTU — Sacramento, California, United States
• Ucsf Aids Crs — San Francisco, California, United States
• University of Colorado Hospital CRS — Aurora, Colorado, United States
• Northwestern University CRS — Chicago, Illinois, United States
• Cook County Hosp. CORE Ctr. — Chicago, Illinois, United States
• Johns Hopkins Adult AIDS CRS — Baltimore, Maryland, United States
• Beth Israel Med. Ctr., ACTU — New York, New York, United States
• NY Univ. HIV/AIDS CRS — New York, New York, United States
• Cornell CRS — New York, New York, United States
• Weill Med. College of Cornell Univ., The Cornell CTU — New York, New York, United States
• Univ. of Cincinnati CRS — Cincinnati, Ohio, United States
• MetroHealth CRS — Cleveland, Ohio, United States
• Vanderbilt Therapeutics CRS — Nashville, Tennessee, United States
• University of Washington AIDS CRS — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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