HIV-1-infection Clinical Trial
Official title:
Pharmacodynamics of Efavirenz 400mg in Treatment-naïve Chinese HIV-infected Patients in a Prospective Cohort Study
NCT number | NCT04596488 |
Other study ID # | XL001 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 1, 2017 |
Est. completion date | December 30, 2019 |
Verified date | October 2020 |
Source | Peking Union Medical College Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Evaluating the efficacy, pharmacodynamics, and safety of Efavirenz 400mg in treatment-naïve Chinese HIV-infected patients.
Status | Completed |
Enrollment | 25 |
Est. completion date | December 30, 2019 |
Est. primary completion date | December 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - (1) HIV treatment-naïve, (2) age between 18 years or older, (3) be willing to complete the HAMD and PSQI scale and follow-up regularly, (5) not participating in other studies. Exclusion Criteria: - (1) acute HIV-1-infected patients, (2) an AIDS-defining illness such as pneumocystis pneumonia, tuberculosis within 2 weeks of entry, (3) transaminase and alkaline phosphatase levels beyond three times the upper limit of the normal range, bilirubin level more than 2.5 times the upper limit of the normal range, and serum creatinine level excess 1.5 times the upper limit of the normal range, (4) pregnancy or breast feeding |
Country | Name | City | State |
---|---|---|---|
China | Peking Union Medical College Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking Union Medical College Hospital | CAMS Initiative for Innovative Medicine, National Key Technologies R&D Program for the 12th Five-year Plan, National Key Technologies R&D Program for the 13th Five-year Plan |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Viral suppression | The proportion of patients with viral load less than 50 copies/mL | 48 weeks | |
Secondary | Drug concentration | The proportion of patients with plasma efavirenz concentration between 1 mg/L and 4mg/L | 48 weeks | |
Secondary | Neuropsychiatric adverse events | The proportion of patients with HAMD <8 and PSQI <10 (less neuropsychiatric adverse effects) | 48 weeks |
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