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

NCT ID: NCT00476463

Last Updated: 2016-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-30
• Study Completion Date: 2008-12-31

Brief Summary

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.

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.

Conditions

Hepatitis B Virus; HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

AZT+FTC+EFV

Group Type: ACTIVE_COMPARATOR

Emtricitabine

Intervention Type: DRUG

Emtricitabine 200 mg OD + Zidovudine 300 mg BID + EFV OD compared to TDF + FTC + EFV

2

TDF+FTC+EFV

Group Type: ACTIVE_COMPARATOR

Emtricitabine

Intervention Type: DRUG

Emtricitabine 200 mg OD + Zidovudine 300 mg BID + EFV OD compared to TDF + FTC + EFV

Interventions

Emtricitabine

Emtricitabine 200 mg OD + Zidovudine 300 mg BID + EFV OD compared to TDF + FTC + EFV

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: collaborator

Ministry of Health, Thailand

OTHER_GOV

Sponsor Role: collaborator

The HIV Netherlands Australia Thailand Research Collaboration

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kiat Ruxrungtham, MD

Role: PRINCIPAL_INVESTIGATOR

HIV-NAT Thai Red Cross AIDS Research Center

Locations

HIV-NAT Thai Red Cross AIDS Research Center

Bangkok, , Thailand

Countries

Thailand

Related Links

http://www.hivnat.org

The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)

Other Identifiers

HIV-NAT 023

Identifier Type: -

Identifier Source: org_study_id