A Comparison of Adefovir and Tenofovir for the Treatment of Lamivudine-Resistant Hepatitis B Virus in People With HIV
NCT ID: NCT00033163
Last Updated: 2021-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
90 participants
INTERVENTIONAL
2005-05-31
Brief Summary
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Detailed Description
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This study will include two populations of patients. Patients in Population A are on stable HAART that includes TDF and will either be in Group I (compensated liver disease) or Group II (decompensated liver disease). All patients in Population A will be randomly assigned to one of two arms: Arm 1 patients will receive 10 mg ADV daily and TDF placebo; Arm 2 patients will receive ADV placebo and 300 mg TDF. Patients in Population B are on stable HAART and have never taken TDF as part of their HAART. Population B patients will receive 300 mg TDF daily during the course of the study.
Study visits will occur every 4 weeks for the 96-week study period. Targeted clinical and medication assessments and blood work assessing clotting time, liver function, and blood chemistry will be conducted at each study visit. HIV and HBV DNA viral load will be tested every 12 weeks. CD4 cell counts will be tested at Weeks 24, 48, 72, and 96.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
Interventions
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Adefovir dipivoxil
Tenofovir disoproxil fumarate
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* Compensated liver disease
* Child-Pugh-Turcotte (CPT) score of less than 7
* Decompensated liver disease
* CPT score of 7-12
* 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
* Gastrointestinal (variceal) bleeding
* Brain and nervous system damage as a result of liver disease
* Abnormal blood clotting time
* 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
18 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Bruce Polsky, MD
Role: STUDY_CHAIR
St. Luke's-Roosevelt Hospital Center
Marion Peters, MD
Role: STUDY_CHAIR
University of California, San Francisco
Locations
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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
Countries
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References
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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. doi: 10.1002/hep.510300525.
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. doi: 10.1016/s0140-6736(01)05840-8.
Dieterich DT. HIV and hepatitis B virus: options for managing coinfection. Top HIV Med. 2003 Jan-Feb;11(1):16-9.
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. doi: 10.1097/00126334-200309011-00009.
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. doi: 10.1055/s-2003-39951.
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 virus and HIV infection: ACTG A5127. Hepatology. 2006 Nov;44(5):1110-6. doi: 10.1002/hep.21388.
Johnson VA, Cramer YS, Rosenkranz SL, Becker S, Klingman KL, Kallungal B, Coakley E, Acosta EP, Calandra G, Saag MS; NIH/NIAID AIDS Clinical Trials Group A5210 Protocol Team. Antiretroviral Activity of AMD11070 (An Orally Administered CXCR4 Entry Inhibitor): Results of NIH/NIAID AIDS Clinical Trials Group Protocol A5210. AIDS Res Hum Retroviruses. 2019 Aug;35(8):691-697. doi: 10.1089/AID.2018.0256. Epub 2019 Jun 18.
Other Identifiers
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10678
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG A5127
Identifier Type: -
Identifier Source: secondary_id
AACTG A5127
Identifier Type: -
Identifier Source: secondary_id
A5127
Identifier Type: -
Identifier Source: org_study_id