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Efficacy and Tolerance of Peg-interferon Alpha 2a Added to Tenofovir and Emtricitabine in AgHBe Positive HBV-HIV Co-infected Patients

NCT00391638 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2015-01-15

No results posted yet for this study

Summary

HBe seroconversion is an important goal for anti-HBV treatment, since it is associated with a non progressive liver infection and a better clinical outcome. However, the rate of HBe seroconversion is low in HIV-HBV co-infected patients, mostly treated by tenofovir and emtricitabine. This study will evaluate the efficacy and the safety of a one-year Peg-interferon alpha 2a additional treatment in patients already treated by tenofovir and emtricitabine without reaching HBe seroconversion.

Conditions

Interventions

DRUG

TRUVADA (EMTRICITABINE + TENOFOVIR DF)

Truvada ® (200 mg tablet of 300 mg of emtricitabine + tenofovir DF) Dosage 1 tablet taken orally once a day

BIOLOGICAL

PEGASYS 180μg (Interféron pégylé alpha -2a)

Pegasys ® injection 180μg Dosage: A subcutaneous injection per week

Sponsors & Collaborators

  • Gilead Sciences

    collaborator INDUSTRY

  • Roche Pharma AG

    collaborator INDUSTRY

  • French National Agency for Research on AIDS and Viral Hepatitis

    lead OTHER_GOV

Principal Investigators

  • Lionel Piroth, MD · Centre Hospitalier Universitaire Dijon

  • Fabrice Carrat, MD · Inserm U 707 Paris France

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2011-05-31
Completion
2012-10-31

Countries

  • France

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00391638 on ClinicalTrials.gov