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HIV InfectionsPhase 2NCT00033163

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

A Phase 2 study testing Adefovir dipivoxil and Tenofovir disoproxil fumarate in people with HIV Infections and Hepatitis B, run by National Institute of Allergy and Infectious Diseases (NIAID) at 15 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections, Hepatitis B
What is being tested?
Adefovir dipivoxil and Tenofovir disoproxil fumarate
How many people
90 participants
Where
15 sitesUnited States
Study dates
Start not givento May 2005
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 17Show fewer
  • 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

Who cannot join

  • 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
  • Serious kidney problems within the last 12 months
  • Allergic or sensitive to ADV or TDF
Show all 16Show fewer
  • 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

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

United States15 sites

  • University of Colorado Hospital CRS

    Aurora, Colorado, 80262

  • Johns Hopkins Adult AIDS CRS

    Baltimore, Maryland, 21287

  • Northwestern University CRS

    Chicago, Illinois, 60611

  • Cook County Hosp. CORE Ctr.

    Chicago, Illinois, 60612

  • Univ. of Cincinnati CRS

    Cincinnati, Ohio, 452670405

  • MetroHealth CRS

    Cleveland, Ohio, 441091998

  • Vanderbilt Therapeutics CRS

    Nashville, Tennessee, 37203

  • Beth Israel Med. Ctr., ACTU

    New York, New York, 10003

  • NY Univ. HIV/AIDS CRS

    New York, New York, 10016

  • Cornell CRS

    New York, New York, 10021

  • Weill Med. College of Cornell Univ., The Cornell CTU

    New York, New York

  • UC Davis Medical Center

    Sacramento, California, 95814

  • Univ. of California Davis Med. Ctr., ACTU

    Sacramento, California

  • Ucsf Aids Crs

    San Francisco, California, 94110

  • University of Washington AIDS CRS

    Seattle, Washington, 98104

Other trials in United States

About this study

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

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.

Read the detailed description

HBV presents a worldwide health crisis and is difficult to treat when a patient's HBV strain is no longer responsive to 3TC. Given the significant incidence of 3TC-resistant HBV in patients receiving this drug as part of an antiretroviral regimen, other agents with anti-HBV activity are needed. ADV has shown promising anti-HBV activity in preclinical assessments and in Phase I, II, and III clinical trials. TDF, developed for the treatment of HIV infection, has in vitro activity against HBV. This study will compare TDF/3TC combination therapy with ADV/3TC combination therapy to determine which treatment regimen is more effective in patients coinfected with HBV and HIV.

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.

Being tested
Adefovir dipivoxil, Tenofovir disoproxil fumarate
Keywords
Antiviral Agents, Hepatitis B, Drug Resistance, Microbial, Lamivudine, DNA, Viral, Hepatitis B Virus, Adefovir dipivoxil, Tenofovir disoproxil fumarate, Treatment Experienced
Medical subject headings
HIV Infections, Hepatitis B

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adefovir dipivoxilDrug

  • Tenofovir disoproxil fumarateDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2002 (estimated)
  2. Study completionMay 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Enrolment
90 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00033163
Sponsor's protocol ID
A5127
Other IDs
10678, ACTG A5127, AACTG A5127
Status last verified
Oct 2021
First submitted
8 Apr 2002
Last updated
1 Nov 2021
Results posted
No

Publications

  • 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.

    PubMed 10534354

  • 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.

    PubMed 11551579

  • Dieterich DT. HIV and hepatitis B virus: options for managing coinfection. Top HIV Med. 2003 Jan-Feb;11(1):16-9.

    PubMed 12717046

  • 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.

    PubMed 14562859

  • 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.

    PubMed 12800066

  • 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.

    PubMed 17058225

  • 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.

    PubMed 31099252

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Adefovir dipivoxil and Tenofovir disoproxil fumarate in people with HIV Infections and Hepatitis B, run by National Institute of Allergy and Infectious Diseases (NIAID) at 15 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00033163, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021.

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