Peking Union Medical College Hospital
Overview
- Phase
- Not Applicable
- Intervention
- Efavirenz 400Mg Oral Tablet
- Conditions
- HIV/AIDS
- Sponsor
- Peking Union Medical College Hospital
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Change from Baseline Virological measurements at 12 weeks
- Last Updated
- 5 years ago
Overview
Brief Summary
The present study will be a randomized controlled study in which 500 treatment-naive HIV patients will be randomized 1:1 to Efaviren 400mg v.s. 600mg combined with lamivudine and tenofovir. The whole cohort will be followed for two years. Efficacy and safety of each regimen will be evaluated throughout the study.
Detailed Description
As efaviren has been commonly used as the first-line therapy in HIV infection worldwide, its major side effect i.e. the mental effects have been noticed and has a major influence on the adherence and efficacy of ART regimen. Mental effects of efaviren have been especially critical in Chinese patients, as the effective and toxic ranges of efaviren plasma concentration in Chinese patients are very close to each other. In this study, 500 treatment-naive Chinese patients with a body weight \< 60kg will be screened and recruited. Patients will be randomized 1:1 to efaviren 400mg v.s. 600mg combined with lamivudine and tenofovir. All patients will be followed regularly for 2 years, at 0, 2w, 4w, 3m and every 3 months. Virological and immunological measurements will be done at each visit. Meanwhile, various mental scales will be performed at each visit to evaluate the mental effects of each arm.
Investigators
LI Taisheng
Chief, Department of Infectious Diseases
Peking Union Medical College Hospital
Eligibility Criteria
Inclusion Criteria
- •Provision of signed and dated informed consent form
- •Willingness and availability to engage in study activities for the duration of the study
- •Age between 18-65
- •Documented HIV-1 infection (confirmed by Western blot)
- •Received no prior antiretroviral therapy
Exclusion Criteria
- •Pregnancy or breastfeeding or anticipated pregnancy in two years
- •History of AIDS-defining illness
- •Hemoglobin \< 9g/dl；or peripheral white blood cell counts \< 2000/μl；or neutrophil counts \< 1000 /μl；or platelet count \< 75,000/μl；
- •Liver disease (transaminase and alkaline phosphatase levels more than three times the upper limit of the normal range (ULN), bilirubin level more than 2.5 times the ULN)
- •Chronic kidney disease (serum creatinine level more than 1.5 times the ULN)
- •Patients with a history of injection drug usage
- •Patients with a history of mental disorders
Arms & Interventions
Efavirenz 400MG Oral Tablet
Recruited treatment-naive HIV infected patients will be given Lamivudin 300mg per day, tenofovir 300mg per day and efavirenz 400mg per day as antiretroviral treatment.
Intervention: Efavirenz 400Mg Oral Tablet
Efavirenz 600MG Oral Tablet
Recruited treatment-naive HIV infected patients will be given Lamivudin 300mg per day, tenofovir 300mg per day and efavirenz 600mg per day, per standard dose.
Intervention: Efavirenz 600Mg Oral Tablet
Outcomes
Primary Outcomes
Change from Baseline Virological measurements at 12 weeks
Time Frame: 12 weeks
Plasma viral load
Change from Baseline Virological measurements at 24 weeks
Time Frame: 24 weeks
Plasma viral load
Change from Baseline Virological measurements at 48 weeks
Time Frame: 48 weeks
Plasma viral load
Change from Baseline Virological measurements at 72 weeks
Time Frame: 72 weeks
Plasma viral load
Change from Baseline Virological measurements at 96 weeks
Time Frame: 96 weeks
Plasma viral load
Change from Baseline Immunological measurements at 12 weeks
Time Frame: 12 weeks
CD4 T cell count
Change from Baseline Immunological measurements at 24 weeks
Time Frame: 24 weeks
CD4 T cell count
Change from Baseline Immunological measurements at 48 weeks
Time Frame: 48 weeks
CD4 T cell count
Change from Baseline Immunological measurements at 72 weeks
Time Frame: 72 weeks
CD4 T cell count
Change from Baseline Immunological measurements at 96 weeks
Time Frame: 96 weeks
CD4 T cell count
Secondary Outcomes
- Adverse effects measured by Dizziness Handicap Inventory(0, 12, 24, 48, 72, 96 weeks)
- Adverse effects measured by Hamilton Depression Scale-24(0, 12, 24, 48, 72, 96 weeks)
- Adverse effects measured by Pittsburgh Sleep Quality Index(0, 12, 24, 48, 72, 96 weeks)