Clinical trial NCT04463784: Efficacy of Efavirenz 400mg vs. 600mg Combined With Lamivudine and Tenofovir in Treatment Naive HIV Infection
Official title: Peking Union Medical College Hospital
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV/AIDS
Mental Impairment
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2020-07-09
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from Baseline Virological measurements at 12 weeks
timeFrame: 12 weeks
measure: Change from Baseline Virological measurements at 24 weeks
timeFrame: 24 weeks
measure: Change from Baseline Virological measurements at 48 weeks
timeFrame: 48 weeks
measure: Change from Baseline Virological measurements at 72 weeks
timeFrame: 72 weeks
measure: Change from Baseline Virological measurements at 96 weeks
timeFrame: 96 weeks
measure: Change from Baseline Immunological measurements at 12 weeks
timeFrame: 12 weeks
measure: Change from Baseline Immunological measurements at 24 weeks
timeFrame: 24 weeks
measure: Change from Baseline Immunological measurements at 48 weeks
timeFrame: 48 weeks
measure: Change from Baseline Immunological measurements at 72 weeks
timeFrame: 72 weeks
measure: Change from Baseline Immunological measurements at 96 weeks
timeFrame: 96 weeks
Secondary outcomes:
measure: Adverse effects measured by Dizziness Handicap Inventory
timeFrame: 0, 12, 24, 48, 72, 96 weeks
measure: Adverse effects measured by Hamilton Depression Scale-24
timeFrame: 0, 12, 24, 48, 72, 96 weeks
measure: Adverse effects measured by Pittsburgh Sleep Quality Index
timeFrame: 0, 12, 24, 48, 72, 96 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Taisheng Li, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tongtong Y, Shenghua H, Yin W, Lin C, Huanxia L, Chunrong L, Ruifeng Z, Xiaojing Y, Yuan Y, Yuanhong H, Ke Y. Effectiveness and Safety of Dolutegravir Versus Efavirenz-Based Antiviral Regimen in People Living With HIV-1 in Sichuan Province of China: A Real-World Study. J Acquir Immune Defic Syndr. 2022 Oct 1;91(S1):S1-S7. doi: 10.1097/QAI.0000000000003041.