- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00127959
Virological and Clinical Anti-Hepatitis B Virus (HBV) Efficacy of Tenofovir and Emtricitabine in Patients With HIV/HBV co-Infection
Virological and Clinical Anti-HBV Efficacy of Tenofovir and Emtricitabine in Antiretroviral Naïve Patients With HIV/HBV co-Infection
This is a randomized multicentre trial of emtricitabine (FTC) versus tenofovir (TDF)/FTC in antiretroviral naive subjects with HIV/HBV co-infection over 48 weeks (Clinical Trial A).
Plus, a 12 week viral kinetic substudy comparing a subgroup of patients on Clinical Trial A is being conducted. (Substudy A1)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This is a randomized multicentre trial of FTC vs TDF/FTC in antiretroviral naive subjects with HIV/HBV co-infection over 48 weeks (Clinical Trial A).
Plus, a 12 week viral kinetic substudy comparing a subgroup of patients on Clinical Trial A is being conducted. (Substudy A1)
Primary Objectives:
- To compare the proportion of subjects with HBV DNA levels below the limit of detection (<400 copies/ml) by week 48 in each treatment group
Secondary Objectives:
- To evaluate the emergence of HBV resistance at 48 weeks
- To compare the proportion of patients with undetectable HBV DNA at weeks 12 and 24 in each treatment group
- To compare the proportion of patients who achieve HBeAg and HBsAg seroconversion at weeks 12, 24 and 48 during the study
- To compare changes in ALT from baseline and the rate of hepatic cytolysis (ALT>5x ULN)
- To compare suppression of HIV-1 RNA and changes in CD4/CD8 counts over 48 weeks
- To compare the effect of therapy on histological changes in the liver and the presence of ccc-DNA
Enrollment:
- 24 patients in Clinical trial A (of whom 16 enter substudy A1).
Clinical Trial A:
- Patients with HIV/HBV co-infection who are naive to HIV/HBV therapy, have detectable HBV viraemia and are willing to start antiretroviral therapy.
Inclusion Criteria:
- Written informed consent
- Documented HIV infection
- Age 18 - 70 years
- HBV DNA > 106 copies/ml
Randomization:
- Arm 1: Zidovudine (AZT), emtricitabine (FTC), efavirenz (EFV)
- Arm 2: Tenofovir (TDF), emtricitabine (FTC), efavirenz (EFV)
Undersøgelsestype
Tilmelding
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
-
-
NH
-
Amsterdam, NH, Holland, 1105AZ
- Academic Medical Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Written informed consent
- Documented HIV infection
- Age 18 - 70 years
- HBV DNA > 10E6 copies/ml
- ALT < 10 x ULN (upper limit of normal)
- Creatinine <= 2.0mg/dl
- Platelet count >= 50,000/mm3
- HIV-1 therapy naive
- No prior exposure to anti-HBV agents
Exclusion Criteria:
- Hepatitis C viral RNA (CV-RNA) positive or Anti-hepatitis A virus immunoglobulin M (HAV IgM) positive
- Acute hepatitis (serum ALT > 1000 U/L)
- Prior LAM, TDF, or adefovir dipivoxil (ADV) therapy
- Active opportunistic infection
- Pregnancy or lactation
- Other chronic liver disease
- Concurrent malignancy requiring cytotoxic chemotherapy
- Decompensated or Child's C cirrhosis
- Alfa-fetoprotein (AFP) > 3X ULN (unless negative computed tomography [CT] scan or magnetic resonance imaging [MRI] within 3 months of entry date)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
---|
HBV DNA suppression as measured by comparison of area under the curve (AUC) measurements after 48 weeks therapy
|
Sekundære resultatmål
Resultatmål |
---|
Proportion of patients with undetectable HBV DNA in serum
|
Rate of hepatitis B e antigen (HBeAg) and hepatitis B surface antigen (HBsAg) seroconversion
|
Rate of emergence of lamivudine (LAM)-resistant HBV genotypes
|
Suppression of plasma HIV-RNA (< 50 copies/ml)
|
Changes in CD4+ /CD8+ cell counts
|
Presence of covalently closed circle DNA (cccDNA) on liver biopsy
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Jan Prins, MD PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Studiestol: Joep M.A. Lange, MD PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Ledende efterforsker: Kiat Ruxrungtham, MD PhD, HIVNAT Bangkok
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Patologiske processer
- RNA-virusinfektioner
- Virussygdomme
- Blodbårne infektioner
- Sygdomsegenskaber
- Leversygdomme
- Hepatitis, viral, menneskelig
- Hepadnaviridae infektioner
- DNA-virusinfektioner
- Enterovirus infektioner
- Picornaviridae infektioner
- Infektioner
- Overførbare sygdomme
- Hepatitis B
- Hepatitis
- Hepatitis A
- Co-infektion
- Molekylære mekanismer for farmakologisk virkning
- Anti-infektionsmidler
- Antivirale midler
- Reverse transkriptasehæmmere
- Nukleinsyresyntesehæmmere
- Enzymhæmmere
- Anti-HIV-midler
- Anti-retrovirale midler
- Antimetabolitter
- Cytokrom P-450 enzymhæmmere
- Cytokrom P-450 enzyminducere
- Cytokrom P-450 CYP3A inducere
- Cytokrom P-450 CYP2B6 inducere
- Cytokrom P-450 CYP2C9-hæmmere
- Cytokrom P-450 CYP2C19-hæmmere
- Tenofovir
- Emtricitabin
- Zidovudin
- Efavirenz
Andre undersøgelses-id-numre
- IAT-0038-04
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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