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

• Status: Completed
• Trial end date: 2005-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Adefovir; Adefovir dipivoxil; Lamivudine; Tenofovir

Criteria

Inclusion Criteria for All Participants:

• HIV infected

• HBV infected

• Serum HBV DNA of 100,000 copies/ml or greater

• Positive for serum hepatitis B surface antigen (HBsAg) within 12 weeks prior to study entry

• Agree to use acceptable methods of contraception

• Serum alpha-fetoprotein (AFP) of 50 ng/ml or less within 30 days of study entry. If AFP is greater than 50 ng/ml, the patient must have an imaging study of the liver showing no tumor within 30 days prior to study entry

Inclusion Criteria for Population A:

• Uninterrupted stable HAART regimen at study entry for at least 12 continuous weeks prior to study entry

• HIV viral load of 10,000 copies/ml or less within 12 weeks of study entry

Inclusion Criteria for Population A, Group I:

• Compensated liver disease

• Child-Pugh-Turcotte (CPT) score of less than 7

Exclusion Criteria for Population A, Group I:

• Excess fluid in the space between the membranes lining the abdomen and abdominal organs (ascites)

• Gastrointestinal (variceal) bleeding

• Brain and nervous system damage as a result of liver disease

• Abnormal blood clotting time

Inclusion Criteria for Population A, Group II:

• Decompensated liver disease

• CPT score of 7-12

Inclusion Criteria for Population B:

• Prior HAART regimen

• Never taken TDF as part of HAART regimen

• Serum HBV DNA of 100,000 copies/ml or greater within 12 weeks of study entry

• HIV viral load of greater than 10,000 copies/ml within 12 weeks of study entry

• CPT score less than 13

Exclusion Criteria

• 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