HIV Infections Clinical Trial
Official title:
A Randomized, Phase II, Controlled Trial Comparing the Efficacy of Adefovir Dipivoxil and Tenofovir Disoproxil Fumarate for the Treatment of Lamivudine-Resistant Hepatitis B Virus in Subjects Who Are Co-Infected With HIV
NCT number | NCT00033163 |
Other study ID # | A5127 |
Secondary ID | 10678ACTG A5127A |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Est. completion date | May 2005 |
Verified date | October 2021 |
Source | National Institute of Allergy and Infectious Diseases (NIAID) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 90 |
Est. completion date | May 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado Hospital CRS | Aurora | Colorado |
United States | Johns Hopkins Adult AIDS CRS | Baltimore | Maryland |
United States | Cook County Hosp. CORE Ctr. | Chicago | Illinois |
United States | Northwestern University CRS | Chicago | Illinois |
United States | Univ. of Cincinnati CRS | Cincinnati | Ohio |
United States | MetroHealth CRS | Cleveland | Ohio |
United States | Vanderbilt Therapeutics CRS | Nashville | Tennessee |
United States | Beth Israel Med. Ctr., ACTU | New York | New York |
United States | Cornell CRS | New York | New York |
United States | NY Univ. HIV/AIDS CRS | New York | New York |
United States | Weill Med. College of Cornell Univ., The Cornell CTU | New York | New York |
United States | 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 Washington AIDS CRS | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
Benhamou Y, Bochet M, Thibault V, Calvez V, Fievet MH, Vig P, Gibbs CS, Brosgart C, Fry J, Namini H, Katlama C, Poynard T. Safety and efficacy of adefovir dipivoxil in patients co-infected with HIV-1 and lamivudine-resistant hepatitis B virus: an open-label pilot study. Lancet. 2001 Sep 1;358(9283):718-23. — View Citation
Benhamou Y, Bochet M, Thibault V, Di Martino V, Caumes E, Bricaire F, Opolon P, Katlama C, Poynard T. Long-term incidence of hepatitis B virus resistance to lamivudine in human immunodeficiency virus-infected patients. Hepatology. 1999 Nov;30(5):1302-6. — View Citation
Dieterich DT. HIV and hepatitis B virus: options for managing coinfection. Top HIV Med. 2003 Jan-Feb;11(1):16-9. Review. — View Citation
Peters MG, Andersen J, Lynch P, Liu T, Alston-Smith B, Brosgart CL, Jacobson JM, Johnson VA, Pollard RB, Rooney JF, Sherman KE, Swindells S, Polsky B; ACTG Protocol A5127 Team. Randomized controlled study of tenofovir and adefovir in chronic hepatitis B v — View Citation
Rockstroh JK. Management of hepatitis B and C in HIV co-infected patients. J Acquir Immune Defic Syndr. 2003 Sep;34 Suppl 1:S59-65. Review. — View Citation
Thio CL. Hepatitis B in the human immunodeficiency virus-infected patient: epidemiology, natural history, and treatment. Semin Liver Dis. 2003 May;23(2):125-36. Review. — View Citation
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