CTRI/2012/03/002471
Completed
未知
Studies on Antiviral Therapy that limits the Emergence of HBV Resistance in HIV/HBV Co-infection
Calcutta School of Tropical Medicine0 sites68 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- HIV/HBV co infected ART naive and experienced patients.
- Sponsor
- Calcutta School of Tropical Medicine
- Enrollment
- 68
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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 \< 18 years of age)
- •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 \< 1\.5 mg/dl
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
Outcomes
Primary Outcomes
Not specified
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