HIV/AIDS Clinical Trial
Official title:
Peking Union Medical College Hospital
Verified date | July 2020 |
Source | Peking Union Medical College Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
China | Peking Union Medical College Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking Union Medical College Hospital |
China,
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 |
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