Efficacy of Tenofovir and Emtricitabine in ARV-naive Patients With HIV/HBV Co-infection
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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.
Condition | Intervention | Phase |
---|---|---|
Hepatitis B Virus HIV Infections |
Drug: Emtricitabine |
Phase 2 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
Official Title: | Virological and Clinical Anti-HBV Efficacy of Tenofovir and Emtricitabine in Antiretroviral Naive Patients With HIV/HBV Co-infection |
- HBV DNA suppression to levels below the limit of detection (<400 copies/ml) [ Time Frame: week 48 ] [ Designated as safety issue: Yes ]
- 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 ]
Enrollment: | 24 |
Study Start Date: | April 2005 |
Study Completion Date: | December 2008 |
Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Active Comparator: 1
AZT+FTC+EFV
|
Drug: Emtricitabine
Emtricitabine 200 mg OD + Zidovudine 300 mg BID + EFV OD compared to TDF + FTC + EFV
|
Active Comparator: 2
TDF+FTC+EFV
|
Drug: Emtricitabine
Emtricitabine 200 mg OD + Zidovudine 300 mg BID + EFV OD compared to TDF + FTC + EFV
|
Detailed Description:
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.
![](https://webarchive.library.unt.edu/web/20130302074202im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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:
- HBsAg positive and
- HBc core IgM antibody negative and
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
![](https://webarchive.library.unt.edu/web/20130302074202im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Thailand | |
HIV-NAT Thai Red Cross AIDS Research Center | |
Bangkok, Thailand, 10330 |
Principal Investigator: | Kiat Ruxrungtham, MD | HIV-NAT Thai Red Cross AIDS Research Center |
![](https://webarchive.library.unt.edu/web/20130302074202im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Additional Information:
No publications provided
Responsible Party: | Prof. Kiat Ruxrungtham, HIV-NAT |
ClinicalTrials.gov Identifier: | NCT00476463 History of Changes |
Other Study ID Numbers: | HIV-NAT 023 |
Study First Received: | May 20, 2007 |
Last Updated: | June 4, 2010 |
Health Authority: | Thailand: Food and Drug Administration |
Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:
TDF+FTC FTC HIV/HBV TDF compared to TDF+FTC in HIV/HBV Treatment Naive |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Hepatitis Hepatitis A Hepatitis B Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Liver Diseases |
Digestive System Diseases Hepatitis, Viral, Human Enterovirus Infections Picornaviridae Infections Hepadnaviridae Infections DNA Virus Infections Tenofovir Emtricitabine Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Retroviral Agents Antiviral Agents |
ClinicalTrials.gov processed this record on February 28, 2013