PHASE II, DOUBLE-BLIND, RANDOMIZED, PACEBO-CONTROLLED STUDY ON SAFETY AND EFFECTIVENESS AT AGGREGATE ENTECAVIR TO CURRENT THERAPY WITH LAMIVUDINE IN PATIENTS CO-INFECTED WITH HIV AND VHB WHO PRESENT VIREMIA FOR HEPATITIS B DURING TREATMENT WITH LAMIVUDINE

Not Applicable

• Conditions: -B16 Acute hepatitis B; Acute hepatitis B; B16

• Registration Number: PER-046-02
• Lead Sponsor: BRISTOL MYERS SQUIBB PERU S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2002-07-11
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Documented history of co-infection with HIV and HBV
Stable Anti Retroviral Therapy regimen containing lamivudine 150 mg BID for at least 24 weeks prior to enrollment;
Documented HBV viremia on screening and at least at 4 weeks prior to screening
HBe Ag-positive or HBe Ag-negative / anti-HBe-positive
HIV viral load below 400 copies/mL by the Roche Amplicor(TM) 1.5 HIV PCR assay at screening and equally low at least 12 weeks prior to screening
Absence of Co-Infection with hepatitis C virus (HCV) or hepatitis D virus (HDV)
Absence of other forms of liver disease e.g., alcoholic, autoimmune, biliary disease
Less that 1/2 weeks of prior therapy with nucleoside/nucleotide analogue (excluding lamivudine) with activity against HBV (including e.g. famciclovir, tenofovir, ganciclovir, adefovir). No receipt of any of these therapies within 24 weeks prior to randomization into this study.

Exclusion Criteria

not contemplated

Study & Design

• Study Type: Interventional
• Study Design: Not specified