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

Primary Purpose

HIV/AIDS, Mental Impairment

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Efavirenz 400Mg Oral Tablet
Efavirenz 600Mg Oral Tablet
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV/AIDS

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Peking Union Medical College Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Efavirenz 400MG Oral Tablet

Efavirenz 600MG Oral Tablet

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change from Baseline Virological measurements at 12 weeks
Plasma viral load
Change from Baseline Virological measurements at 24 weeks
Plasma viral load
Change from Baseline Virological measurements at 48 weeks
Plasma viral load
Change from Baseline Virological measurements at 72 weeks
Plasma viral load
Change from Baseline Virological measurements at 96 weeks
Plasma viral load
Change from Baseline Immunological measurements at 12 weeks
CD4 T cell count
Change from Baseline Immunological measurements at 24 weeks
CD4 T cell count
Change from Baseline Immunological measurements at 48 weeks
CD4 T cell count
Change from Baseline Immunological measurements at 72 weeks
CD4 T cell count
Change from Baseline Immunological measurements at 96 weeks
CD4 T cell count

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
July 15, 2018
Last Updated
July 3, 2020
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04463784
Brief Title
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

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
August 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS, Mental Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Efavirenz 400MG Oral Tablet
Arm Type
Experimental
Arm Description
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.
Arm Title
Efavirenz 600MG Oral Tablet
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Efavirenz 400Mg Oral Tablet
Intervention Description
The experimental arm will receive 400mg efavirenz per randomization with other two antiretroviral medication (tenofovir and lamivudine).
Intervention Type
Drug
Intervention Name(s)
Efavirenz 600Mg Oral Tablet
Intervention Description
The active comparator arm will receive 600mg efavirenz per randomization with other two antiretroviral medication (tenofovir and lamivudine).
Primary Outcome Measure Information:
Title
Change from Baseline Virological measurements at 12 weeks
Description
Plasma viral load
Time Frame
12 weeks
Title
Change from Baseline Virological measurements at 24 weeks
Description
Plasma viral load
Time Frame
24 weeks
Title
Change from Baseline Virological measurements at 48 weeks
Description
Plasma viral load
Time Frame
48 weeks
Title
Change from Baseline Virological measurements at 72 weeks
Description
Plasma viral load
Time Frame
72 weeks
Title
Change from Baseline Virological measurements at 96 weeks
Description
Plasma viral load
Time Frame
96 weeks
Title
Change from Baseline Immunological measurements at 12 weeks
Description
CD4 T cell count
Time Frame
12 weeks
Title
Change from Baseline Immunological measurements at 24 weeks
Description
CD4 T cell count
Time Frame
24 weeks
Title
Change from Baseline Immunological measurements at 48 weeks
Description
CD4 T cell count
Time Frame
48 weeks
Title
Change from Baseline Immunological measurements at 72 weeks
Description
CD4 T cell count
Time Frame
72 weeks
Title
Change from Baseline Immunological measurements at 96 weeks
Description
CD4 T cell count
Time Frame
96 weeks
Secondary Outcome Measure Information:
Title
Adverse effects measured by Dizziness Handicap Inventory
Description
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.
Time Frame
0, 12, 24, 48, 72, 96 weeks
Title
Adverse effects measured by Hamilton Depression Scale-24
Description
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.
Time Frame
0, 12, 24, 48, 72, 96 weeks
Title
Adverse effects measured by Pittsburgh Sleep Quality Index
Description
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.
Time Frame
0, 12, 24, 48, 72, 96 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taisheng Li, PhD, MD
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
36094508
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.
Results Reference
derived

Learn more about this trial

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

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