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A Comparison of Adefovir and Tenofovir for the Treatment of Lamivudine-Resistant Hepatitis B Virus in People With HIV Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about A Comparison of Adefovir and Tenofovir for the Treatment of Lamivudine-Resistant Hepatitis B Virus in People With HIV conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Comparison of Adefovir and Tenofovir for the Treatment of Lamivudine-Resistant Hepatitis B Virus in People With HIV Clinical research trials and A Comparison of Adefovir and Tenofovir for the Treatment of Lamivudine-Resistant Hepatitis B Virus in People With HIV medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like A Comparison of Adefovir and Tenofovir for the Treatment of Lamivudine-Resistant Hepatitis B Virus in People With HIV. A Comparison of Adefovir and Tenofovir for the Treatment of Lamivudine-Resistant Hepatitis B Virus in People With HIV Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a A Comparison of Adefovir and Tenofovir for the Treatment of Lamivudine-Resistant Hepatitis B Virus in People With HIV clinical trial. Test subjects typically obtain the finest healthcare available for their A Comparison of Adefovir and Tenofovir for the Treatment of Lamivudine-Resistant Hepatitis B Virus in People With HIV condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Comparison of Adefovir and Tenofovir for the Treatment of Lamivudine-Resistant Hepatitis B Virus in People With HIV  A Comparison of Adefovir and Tenofovir for the Treatment of Lamivudine-Resistant Hepatitis B Virus in People With HIV
A Comparison of Adefovir and Tenofovir for the Treatment of Lamivudine-Resistant Hepatitis B Virus in People With HIV
For Condition: Hepatitis B,HIV Infections
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Active Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 90
Location and Contact Information:
Overall Study Official:
BrucePolsky, Study Chair, St. Luke's-Roosevelt Hospital Center
The Core Ctr *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Joanne Despotes 312-572-4545
Chelsea Clinic *Recruiting*
New York City, New York, 10011
United States
Recruiting Todd Stroberg 212-746-7198
Univ of North Carolina *No longer recruiting*
Chapel Hill, North Carolina, 275997215
United States
No longer recruiting
Univ of California San Francisco *Recruiting*
San Francisco, California, 94110
United States
Recruiting Julieann Lewis 415-514-0550
MetroHealth Med Ctr *Recruiting*
Cleveland, Ohio, 441091998
United States
Recruiting Ann Conrad 216-778-5489
UC Davis Med Ctr, CARES Clinic *Recruiting*
Sacramento, California, 95814
United States
Recruiting Susan Hulse 916-734-8637
NYU/Bellevue *Recruiting*
New York City, New York, 10016
United States
Recruiting Maura Laverty 212-263-6565
Beth Israel Med Ctr *No longer recruiting*
New York City, New York, 10003
United States
No longer recruiting
University of California San Diego Antiviral Research Ctr *No longer recruiting*
San Diego, California, 92103
United States
No longer recruiting
Northwestern Univ Med School *Recruiting*
Chicago, Illinois, 60611
United States
Recruiting Baiba Berzins 312-695-5012
Beth Israel Deaconess - West Campus *Recruiting*
Boston, Massachusetts, 02215
United States
Recruiting Helen Fitch 617-632-0785
Univ of Washington (Seattle) *Recruiting*
Seattle, Washington, 98104
United States
Recruiting Jeanne Conley 206-731-8877
Mount Sinai Med Ctr *Recruiting*
New York City, New York, 10029
United States
Recruiting Eileen Chusid 212-241-0433
Comprehensive Care Clinic *Recruiting*
Nashville, Tennessee, 37203
United States
Recruiting Janet Nicotera 615-467-0154
Univ of Colorado Health Sciences Ctr *Recruiting*
Denver, Colorado, 80262
United States
Recruiting M Ray 303-372-5535
Univ of Hawaii *No longer recruiting*
Honolulu, Hawaii, 96816
United States
No longer recruiting
The Cornell Clinical Trials Unit *Recruiting*
New York City, New York, 10021
United States
Recruiting Valery Hughes 212-746-4393
Univ of Cincinnati *Recruiting*
Cincinnati, Ohio, 452670405
United States
Recruiting Tammy Powell 513-584-8373
Univ of Texas, Southwestern Med Ctr *Recruiting*
Dallas, Texas, 75390
United States
Recruiting Chip Lohner 214-590-0414
Johns Hopkins Hosp *Recruiting*
Baltimore, Maryland, 21287
United States
Recruiting Charles Raines 410-614-4487
Univ of Texas Galveston *Recruiting*
Galveston, Texas, 775550435
United States
Recruiting Carrie Derkowski 409-747-0241
Additional Information:
Study ID Numbers: ACTG A5127; AACTG A5127
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00033163
Other Hepatitis B Studies:
1. Lamivudine and Adefovir to Treat Chronic Hepatitis B
2. Treatment of Hepatitis in Patients who are Triple-Infected with HIV, Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV)
3. The Tolerance of HIV-Infected Patients with Herpes Group Virus Infections to Oral Doses of FIAU
4. A Phase II Study of the Safety and Efficacy of Adding Entecavir to Current Lamivudine Therapy in HIV and HBV Co-Infected Patients Who Have Hepatitis B Viremia While Being Treated with Lamivudine
5. Prevention of Recurrent Hepatitis B after Liver Transplantation
Related Studies:
Other Hepatitis B Clinical Trials
Other Texas Clinical Trials
Other Dallas Clinical Trials
A Comparison of Adefovir and Tenofovir for the Treatment of Lamivudine-Resistant Hepatitis B Virus in People With HIV
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