- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00033163
A Comparison of Adefovir and Tenofovir for the Treatment of Lamivudine-Resistant Hepatitis B Virus in People With HIV
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
연구 개요
상세 설명
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.
연구 유형
등록
단계
- 2 단계
연락처 및 위치
연구 장소
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California
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Sacramento, California, 미국, 95814
- UC Davis Medical Center
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Sacramento, California, 미국
- Univ. of California Davis Med. Ctr., ACTU
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San Francisco, California, 미국, 94110
- Ucsf Aids Crs
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Colorado
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Aurora, Colorado, 미국, 80262
- University of Colorado Hospital CRS
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Illinois
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Chicago, Illinois, 미국, 60612
- Cook County Hosp. CORE Ctr.
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Chicago, Illinois, 미국, 60611
- Northwestern University CRS
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Maryland
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Baltimore, Maryland, 미국, 21287
- Johns Hopkins Adult AIDS CRS
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New York
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New York, New York, 미국, 10003
- Beth Israel Med. Ctr., ACTU
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New York, New York, 미국
- Weill Med. College of Cornell Univ., The Cornell CTU
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New York, New York, 미국, 10016
- NY Univ. HIV/AIDS CRS
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New York, New York, 미국, 10021
- Cornell CRS
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Ohio
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Cincinnati, Ohio, 미국, 452670405
- Univ. of Cincinnati CRS
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Cleveland, Ohio, 미국, 441091998
- MetroHealth CRS
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Tennessee
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Nashville, Tennessee, 미국, 37203
- Vanderbilt Therapeutics CRS
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Washington
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Seattle, Washington, 미국, 98104
- University of Washington AIDS CRS
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
공동 작업자 및 조사자
수사관
- 연구 의자: Bruce Polsky, MD, St. Luke's-Roosevelt Hospital Center
- 연구 의자: Marion Peters, MD, University of California, San Francisco
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- A5127
- 10678 (DAIDS ES)
- ACTG A5127
- AACTG A5127
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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