HIV Infections Clinical Trial
Official title:
A Prospective, Open-label 96-week Observational Pilot Study to Compare the Safety of Efavirenz Versus Nevirapine (Each in Combination With Zidovudine and Lamivudine or Tenofovir and Lamivudine) in Treating HIV Positive Patients With Mild Baseline Liver Function Test Impairment, and/or Hepatitis B or Hepatitis C Co-infection.
Verified date | December 2010 |
Source | Henan Provincial Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Ethics Committee |
Study type | Observational |
The purpose of this study is to demonstrate the difference in frequency and level of liver function disturbance between patients on efavirenz based ART, and patients on nevirapine based ART in HBV and HCV co-infected patients, (and/or with patients with abnormal liver function prior to ART), in China. Liver function tests will be measured at baseline and follow-up.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | December 2012 |
Est. primary completion date | October 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: (Patients must meet all of the following criteria to enter this study.) - Patients must be >18years of age and < 60 years of age - Patients must be antiretroviral naive and have a HIV-1 RNA level=500 copies/ml - Patients with AST or ALT > 2x the upper limit of normal, and TBIL > 1.5x the upper limit of normal - CD4 count to be <250 in female patients and <350 in male patients at entry - Hemoglobin content to be > 90g/L - Neutrophil cell count to be > 0.75 x 109/L - Patients must be willing to accept the Exclusion criteria: (Patients meeting one or more of the following criteria will not be enrolled in this study.) - Patients with allergies to or other contraindications for the selected ARV regimens. - AST or ALT > 5x the upper limit of normal - TBIL>2.5 x the upper limit of normal - TB co-infection and other co-infection - Pregnant or breastfeeding women - Intravenous drug users - Patient's education level that would interfere with the medical, adherence and withdrawal symptoms evaluation. |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Henan Provincial Hospital | Merck Sharp & Dohme Corp. |
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