drugset / Trial / NCT00391638
Efficacy and Tolerance of Peg-interferon Alpha 2a Added to Tenofovir and Emtricitabine in AgHBe Positive HBV-HIV Co-infected Patients
Phase 2/3
Completed
56 enrolled
French National Agency for Research on AIDS and Viral Hepatitis
Gilead Sciences · collabRoche Pharma AG · collab
Non-randomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2007-01
- Primary completion
- 2011-05
- Completion
- 2012-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Peginterferon alfa-2a | Protein / enzyme biologic | 180 ug | Subcutaneous |
| Background | Tenofovir disoproxil fumarate | Small molecule | 300 mg | Oral |
| Background | emtricitabine | Other / unclassified | 200 mg | Oral |