Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:50 PM
Ignite Modification Date:
2025-12-24 @ 2:50 PM
NCT ID:
NCT00127959
Eligibility Criteria:
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00127959
Study Brief:
Protocol Section:
NCT00127959