Health Condition 1: null- HIV/HBV co infected ART naive and experienced patients.
Conditions
Interventions
Intervention1: Tenofovir+ Lamivudine (3TC) + Efavirenz: Tenofovir(300mg)+ Lamivudine (300mg)
Dose of Therapy: fixed dose co-formulated tablet of the above dose
Mode of Administration: Oral Frequency:
Sponsors
Calcutta School of Tropical Medicine
Eligibility
Inclusion criteria
Inclusion criteria: Study â?? I 1) Patients above 14 years with documented HIV infection as per NACO guideline along with chronic Hepatitis B 2) HIV/HBV co-infection of unknown duration with indication of starting ART 3) Willing to give written informed consent (by self or by guardian in case of Study â?? II 1. HBV mono- infected chronic hepatitis patients on 3TC treatment for one year or more. 2. HIV positive HBV co-infected patients on lamivudine containing ART for at least 1 year Study â?? I & II 1) Blood Parameters a. Serum creatinine 2) Negative for Pregnancy test
Exclusion criteria
Exclusion criteria: 1. Active alcohol abuse over last 6 months or > 40 gm/week and any substance use that physician feels can affect the adherence 2. Presence of associated co-infection with HCV, HAV or HEV 3. Associated life-threatening disease 4. Presence of any malignancy 5. Elevated serum creatinine level > 1.5 mg/dl documented at least twice at one week interval in the last three months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.HBV DNA suppression rate. 2. Prevalence of POL gene mutation.Timepoint: 24,48,72 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| HBeAg seroconvertion rate,ALT normalization,CD4 recoveryTimepoint: 24,48,72 weeks | — |
Countries
India
Contacts
Public ContactDr Subhasish Kamal Guha
Calcutta School of Tropical Medicine
Outcome results
None listed