study with HIV-HBV coinfected patients.
- Conditions
- Health Condition 1: null- HIV/HBV co infected ART naive and experienced patients.
- Registration Number
- CTRI/2012/03/002471
- Lead Sponsor
- Calcutta School of Tropical Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 68
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
2)Negative for Pregnancy test
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.HBV DNA suppression rate. <br/ ><br>2. Prevalence of POL gene mutation.Timepoint: 24,48,72 weeks
- Secondary Outcome Measures
Name Time Method HBeAg seroconvertion rate,ALT normalization,CD4 recoveryTimepoint: 24,48,72 weeks