Compare to the Safety of Efavirenz and Nevirapine in Treating HIV Positive Patients With Mild Baseline Liver Function Test Impairment, and/or Hepatitis B or Hepatitis C Co-infection

NCT01273142 | Unknown

• 1 other identifier: zzly-37183
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

HIV Infections; Liver Toxicity; Hepatitis Co-infection

Keywords

Human Immunodeficiency Virus, liver toxicity, hapatitis co-infection

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Antiretroviral treatment naive patients with HIV-1 RNA level≥500 copies/ml and with AST or ALT \> 2x the upper limit of normal, and TBIL \> 1.5x the upper limit of normal.

You may qualify if:

• (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

You may not qualify if:

• (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.

Sponsors & Collaborators

• Henan Provincial People's Hospital: lead
• Merck Sharp & Dohme LLC: collaborator

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 6, 2011
• First Posted: January 10, 2011
• Study Start: January 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 10, 2011

Record last verified: 2010-12