Clinical Trials

MainTitle

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

The recruitment status of this study is unknown.

Verified December 2010

Sponsor
Henan Provincial Hospital

Collaborator
Merck Sharp & Dohme Corp.

Information provided by (Responsible Party)
Henan Provincial Hospital
ClinicalTrials.gov Identifier
NCT01273142

First received: January 6, 2011
Last updated: January 7, 2011
Last Verified: December 2010
History of Changes
Purpose

Purpose

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.

Condition
HIV Infections
Liver Toxicity
Hepatitis Co-infection

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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.

Further study details as provided by Henan Provincial Hospital:

Estimated Enrollment: 100
Study Start Date: January 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)

Detailed Description:

The introduction of highly active antiretroviral therapy (HAART) has led to a significant reduction in AIDS-related morbidity and mortality. However, the frequent occurrence of chronic hepatitis progressing toward cirrhosis and/or hepatocarcinoma has been recognized as an increasing contributor to death of HIV-infected patients since early in the HAART era In China among the estimated 700,000 people living with HIV in China as of 20061, the percentage of HIV/HCV co-infected patients is high at 56.9%2. For these reasons, during HAART scrupulous attention should paid to the patients' liver function. At present, for price consideration, the NNRTI HIV drug used for antiretroviral therapy in China is nevirapine, which may lead to higher potential risk of liver function disturbance in clinical practice than efavirenz4-5.Roberto Manfredi and his colleagues3found that in a NVP treated group, patients showed at least a 2-fold increase of transaminases versus baseline as hepotoxicity index, while in EFV group, the number of patients with hepotoxicity showed a reduction, Also in the same study, time to reach transaminase peak value was shorter in the NVP group, which also demonstrate the liver toxicity side effect in NVP group. Recently some data has also shown an unusually high incidence of liver function disturbance in patients on HIV antiretroviral therapy in China6. Therefore to evaluate frequency and risk of patient hepatotoxicity caused by different HAART regimens in HBV-/HCV- co-infected HIV patients is necessary to provide evidence therapy for what HAART treatment should be used in China.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 60 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  
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.

Criteria

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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01273142

Sponsors and Collaborators

Henan Provincial Hospital
Merck Sharp & Dohme Corp.
More Information

More Information


Responsible Party: Henan Provincial Hospital, Henan Provincial Infectious Disease Hospital  
ClinicalTrials.gov Identifier: NCT01273142   History of Changes  
Other Study ID Numbers: zzly-37183  
Study First Received: January 6, 2011  
Last Updated: January 7, 2011  

Keywords provided by Henan Provincial Hospital:

Human Immunodeficiency Virus, liver toxicity, hapatitis co-infection

Additional relevant MeSH terms:
Infection
Communicable Diseases
Hepatitis
Hepatitis A
Hepatitis C
HIV Infections
Hepatitis B
Coinfection
Efavirenz
Nevirapine

ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.