HIV InfectionsNCT01273142
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
An observational study of HIV Infections and Liver Toxicity, run by Henan Provincial People's Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- HIV Infections, Liver Toxicity, Hepatitis Co-infection
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- (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
Who cannot join
- (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.
About this study
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.
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.
Read the 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.
- Conditions
- HIV Infections, Liver Toxicity, Hepatitis Co-infection
- Keywords
- Human Immunodeficiency Virus, liver toxicity, hapatitis co-infection
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionOct 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01273142
- Sponsor's protocol ID
- zzly-37183
- Status last verified
- Dec 2010
- First submitted
- 6 Jan 2011
- Last updated
- 10 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01273142
- Acronym / sponsor ID
- zzly-37183
- Conditions
- HIV Infections, Liver Toxicity, Hepatitis Co-infection
- Keywords
- Human Immunodeficiency Virus, liver toxicity, hapatitis co-infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Henan Provincial People's HospitalUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jan 2011
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 10 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (8 listed)
- (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
Key exclusion criteria (8 listed)
- (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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Liver Toxicity, run by Henan Provincial People's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2011.