Efficacy of Efavirenz 400mg vs. 600mg Combined With Lamivudine and Tenofovir in Treatment Naive HIV Infection

HIV/AIDS Clinical Trial

Official title:

Peking Union Medical College Hospital

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04463784
• Other study ID #: CACT 1809
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: August 2021

Study information

• Verified date: July 2020
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: August 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS
• Mental Impairment

Intervention

Drug:
• Efavirenz 400Mg Oral Tablet
The experimental arm will receive 400mg efavirenz per randomization with other two antiretroviral medication (tenofovir and lamivudine).
• Efavirenz 600Mg Oral Tablet
The active comparator arm will receive 600mg efavirenz per randomization with other two antiretroviral medication (tenofovir and lamivudine).

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Virological measurements at 12 weeks	Plasma viral load	12 weeks
Primary	Change from Baseline Virological measurements at 24 weeks	Plasma viral load	24 weeks
Primary	Change from Baseline Virological measurements at 48 weeks	Plasma viral load	48 weeks
Primary	Change from Baseline Virological measurements at 72 weeks	Plasma viral load	72 weeks
Primary	Change from Baseline Virological measurements at 96 weeks	Plasma viral load	96 weeks
Primary	Change from Baseline Immunological measurements at 12 weeks	CD4 T cell count	12 weeks
Primary	Change from Baseline Immunological measurements at 24 weeks	CD4 T cell count	24 weeks
Primary	Change from Baseline Immunological measurements at 48 weeks	CD4 T cell count	48 weeks
Primary	Change from Baseline Immunological measurements at 72 weeks	CD4 T cell count	72 weeks
Primary	Change from Baseline Immunological measurements at 96 weeks	CD4 T cell count	96 weeks
Secondary	Adverse effects measured by Dizziness Handicap Inventory	Measure statistically significant difference in perception of dizziness by administering the Dizziness Handicap Inventory (DHI) between two groups at different time point. The 25-item tool comprises three sub-scales: physical (DHI?P; 7 items), emotional (DHI?E; 9 items), and functional (DHI?F; 9 items) and each item is scored from 0 to 4. Grading standard: 0-30 points is defiend as minor obstacles, 31-60 points as moderate obstacle, and 61-100 points as serious obstacle with high risk of falling.	0, 12, 24, 48, 72, 96 weeks
Secondary	Adverse effects measured by Hamilton Depression Scale-24	Measure statistically significant difference in perception of depression by administering the Hamilton Depression Scale-24 (HAMD-24) between two groups at different time point. The Hamilton Depression Rating Scale (HAMD) has a total of 24 items. 14 items were scored from 0 to 4, and 10 items were scored from 0 to 2. The total score that less than 8 points is defined as no depression, 8 to 20 points as may be depression, scores that more than 20 is defined as mild or moderate depression, and more than 35 points as severe depression.	0, 12, 24, 48, 72, 96 weeks
Secondary	Adverse effects measured by Pittsburgh Sleep Quality Index	Measure statistically significant difference in perception of sleep quality by administering the Pittsburgh Sleep Quality Index (PSQI) between two groups at different time point. PSQI was used to assess the sleep quality of subjects in the last month. It consists of 19 self-evaluation items and 5 other evaluation items, of which only 18 self-evaluation items participate in scoring. 18 items constitute 7 components, and each component is scored according to 0 ~ 3 grades. The PSQI total score ranges from 0 to 21. The higher the score indicates the worser sleep quality.	0, 12, 24, 48, 72, 96 weeks