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Efficacy of Tenofovir and Emtricitabine in ARV-naive Patients With HIV/HBV Co-infection

This study has been completed.
Sponsor:
Collaborators:
Gilead Sciences
Ministry of Health, Thailand
Information provided by:
The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:
NCT00476463
First received: May 20, 2007
Last updated: June 4, 2010
Last verified: June 2010

May 20, 2007
June 4, 2010
April 2005
December 2008   (final data collection date for primary outcome measure)
HBV DNA suppression to levels below the limit of detection (<400 copies/ml) [ Time Frame: week 48 ] [ Designated as safety issue: Yes ]
HBV DNA suppression to levels below the limit of detection (<400 copies/ml) [ Time Frame: week 48 ]
Complete list of historical versions of study NCT00476463 on ClinicalTrials.gov Archive Site
  • HBV suppression as measured by comparison of AUC measurements at 12 and 24 weeks [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: Yes ]
  • Proportion of patients with undetectable HBV DNA in serum at 12 and 24 weeks [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: Yes ]
  • Rate of HBeAg and HBsAg seroconversion at 12, 24 and 48 weeks. [ Time Frame: 12, 24 and 48 weeks ] [ Designated as safety issue: Yes ]
  • Rate of emergence of LAM-resistant HBV genotypes at 48 weeks. [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Rate of hepatic cytolysis (ALT level > 5x ULN). [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline in ALT levels and time to ALT normalization. [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Suppression of plasma HIV-RNA (< 50 copies/ml) through 48 weeks. [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Changes in CD4+ /CD8+ cell counts through 48 weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Toxicity [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Assessment of effect of therapy on histological changes in the liver and effect on ccc-HBV-DNA [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • HBV suppression as measured by comparison of AUC measurements at 12 and 24 weeks [ Time Frame: 12 and 24 weeks ]
  • Proportion of patients with undetectable HBV DNA in serum at 12 and 24 weeks [ Time Frame: 12 and 24 weeks ]
  • Rate of HBeAg and HBsAg seroconversion at 12, 24 and 48 weeks. [ Time Frame: 12, 24 and 48 weeks ]
  • Rate of emergence of LAM-resistant HBV genotypes at 48 weeks. [ Time Frame: 48 weeks ]
  • Rate of hepatic cytolysis (ALT level > 5x ULN). [ Time Frame: 48 weeks ]
  • Change from baseline in ALT levels and time to ALT normalization. [ Time Frame: 48 weeks ]
  • Suppression of plasma HIV-RNA (< 50 copies/ml) through 48 weeks. [ Time Frame: 48 weeks ]
  • Changes in CD4+ /CD8+ cell counts through 48 weeks [ Time Frame: 48 weeks ]
  • Toxicity [ Time Frame: 48 weeks ]
  • Assessment of effect of therapy on histological changes in the liver and effect on ccc-HBV-DNA [ Time Frame: 48 weeks ]
Not Provided
Not Provided
 
Efficacy of Tenofovir and Emtricitabine in ARV-naive Patients With HIV/HBV Co-infection
Virological and Clinical Anti-HBV Efficacy of Tenofovir and Emtricitabine in Antiretroviral Naive Patients With HIV/HBV Co-infection

Combination therapy with anti-HBV activity may both increase HBV suppression rates and reduce emergence of resistant strains. Several new therapeutic agents are currently in development, however combination therapy trials in the HBV-infected population have only recently commenced. No such trials have been undertaken in the HIV/HBV co-infected population.

The primary study objective is to compare HBV DNA suppression to levels below the limit of detection (<400 copies/ml) by week 48 in each treatment group. Virological and clinical anti-HBV efficacy of tenofovir and emtricitabine in antiretroviral naive patients with HIV/HBV co-infection.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hepatitis B Virus
  • HIV Infections
Drug: Emtricitabine
Emtricitabine 200 mg OD + Zidovudine 300 mg BID + EFV OD compared to TDF + FTC + EFV
  • Active Comparator: 1
    AZT+FTC+EFV
    Intervention: Drug: Emtricitabine
  • Active Comparator: 2
    TDF+FTC+EFV
    Intervention: Drug: Emtricitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
December 2008
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Written informed consent
  • Documented HIV infection (positive serology for HIV-1 and detectable HIV-1 RNA)
  • Age 18 - 70 years
  • HBV DNA > 106 copies/ml
  • HBsAg positive for > 6 months

In case documented duration of HBsAg seropositive is less than 6 months (this situation is most likely to occur in patients newly presenting to the HIV-outpatient clinic) the patient is eligible if the patient is:

  1. HBsAg positive and
  2. HBc core IgM antibody negative and
  3. the liver biopsy gives evidence for a chronic active hepatitis. Thus making it likely that this patient has acquired the HBV infection more than 6 months ago.

    • ALT < 10 x ULN
    • Creatinine <= 2.0mg/dl
    • Platelet count >= 50,000/mm3
    • HIV-1 therapy naive
    • No prior exposure to anti-HBV agents (LAM, adefovir, TDF) although prior IFN treatment allowed

Exclusion Criteria:

  • HCV-RNA positive or Anti-HAV IgM positive
  • Acute hepatitis (serum ALT > 1000 U/L)
  • Prior LAM, TDF, or ADV therapy
  • Active opportunistic infection
  • Other causes of chronic liver disease identified ( autoimmune hepatitis, haemochromatosis, Wilsons disease, alfa-1-antitrypsin deficiency)
  • Concurrent malignancy requiring cytotoxic chemotherapy
  • Decompensated or Child's C cirrhosis
  • Alfa-fetoprotein (AFP) > 3X ULN (unless negative CT scan or MRI within 3 months of entry date)
  • Pregnancy or lactation
  • Any other condition which in the opinion of the investigator might interfere with compliance or outcome of the study
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT00476463
HIV-NAT 023
Yes
Prof. Kiat Ruxrungtham, HIV-NAT
The HIV Netherlands Australia Thailand Research Collaboration
  • Gilead Sciences
  • Ministry of Health, Thailand
Principal Investigator: Kiat Ruxrungtham, MD HIV-NAT Thai Red Cross AIDS Research Center
The HIV Netherlands Australia Thailand Research Collaboration
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP