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Clinical Trials/CTRI/2012/03/002471
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
Calcutta School of Tropical Medicine

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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