- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01273142
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
January 7, 2011 updated by: Henan Provincial People's Hospital
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.
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.
Study Overview
Status
Unknown
Conditions
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.
Study Type
Observational
Enrollment (Anticipated)
100
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (Anticipated)
October 1, 2012
Study Completion (Anticipated)
December 1, 2012
Study Registration Dates
First Submitted
January 6, 2011
First Submitted That Met QC Criteria
January 7, 2011
First Posted (Estimate)
January 10, 2011
Study Record Updates
Last Update Posted (Estimate)
January 10, 2011
Last Update Submitted That Met QC Criteria
January 7, 2011
Last Verified
December 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- RNA Virus Infections
- Virus Diseases
- Blood-Borne Infections
- Disease Attributes
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Enterovirus Infections
- Picornaviridae Infections
- Infections
- Communicable Diseases
- Hepatitis B
- Hepatitis
- Hepatitis A
- Hepatitis C
- Coinfection
Other Study ID Numbers
- zzly-37183
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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