Compare to the Safety of Efavirenz and Nevirapine in Treating HIV Positive Patients With Mild Bas… (NCT01273142) | Clinical Trial Compass
UnknownNot Applicable
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
100 participantsStarted 2011-01
Plain-language 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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.