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| Name | Class |
|---|---|
| National Key Technologies R&D Program for the 13th Five-year Plan | UNKNOWN |
| National Key Technologies R&D Program for the 12th Five-year Plan | UNKNOWN |
| CAMS Initiative for Innovative Medicine | UNKNOWN |
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Evaluating the efficacy, pharmacodynamics, and safety of Efavirenz 400mg in treatment-naïve Chinese HIV-infected patients.
Treatment-naive HIV-infected patients are designed to enroll and receive efavirenz 400mg combined with tenofovir (TDF) and lamivudine (3TC) as initial antiretroviral regimens, and monitoring for 48 weeks, to evaluate efavirenz concentration, T-cell subsets, HIV RNA load, and neuropsychiatric tests with Hamilton depression scale (HAMD) and Pittsburgh sleep quality index (PSQI) at baseline, 4, 12, 24, 48 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Efavirenz 400mg+TDF+3TC | Experimental | Combined antiretroviral therapy(cART) consisting of three regimens such as efavirenz, tenofovir and lamivudine is an effective measure for the treatment of HIV-1 infection.Efavirenz 600mg daily was approved by the US Food and Drug Administration in 1998. In this single-arm research, patients were treated with a reduced 400mg dose of efavirenz combined with tenofovir 300mg and lamivudine 300mg once a day. This treatment had to be maintained indefinitely due to the existence of HIV reservoir. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Efavirenz 400mg | Drug | HIV-infected patients were treated with efavirenz 400mg combined with tenofovir 300mg and lamivudine 300mg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Viral suppression | The proportion of patients with viral load less than 50 copies/mL | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Drug concentration | The proportion of patients with plasma efavirenz concentration between 1 mg/L and 4mg/L | 48 weeks |
| Neuropsychiatric adverse events | The proportion of patients with HAMD <8 and PSQI <10 (less neuropsychiatric adverse effects) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Taisheng Li, MD, PhD | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100730 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33485301 | Derived | Xu L, Peng W, Song X, Li Y, Han Y, Zhu T, Fu Q, Du X, Cao W, Li T. Pharmacodynamics of efavirenz 400 mg in treatment-naive Chinese HIV-infected patients in a prospective cohort study. BMC Infect Dis. 2021 Jan 23;21(1):112. doi: 10.1186/s12879-021-05802-8. |
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| ID | Term |
|---|---|
| C098320 | efavirenz |
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| 48 weeks |