Tripterygium Wilfordii Hook F (TwHF) Treatment for Immune Non-responders With HIV-1 Infection
NCT01666990 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2015-08-17
Summary
HIV-1 infection is characterized by progressive depletion of CD4+ T cells that eventually leads to clinically significant immunodeficiency. A chronic generalized immune activation is now being recognized to be the main driving force for T cell depletion, loss of anti-HIV-1 immunity and disease progression during chronic HIV-1 infection. However, it is still unknown whether reducing immune activation will restore CD4 T cell counts and leading to immune reconstitution in chronic HIV infection. Tripterygium Wilfordii Hook F (TwHF) has been demonstrated to decrease immune activation of the host, and can suppress inflammation in human diseases. Here, the investigators propose a hypothesis that TwHF can reduce immune over-activation which subsequently leads to the restoration of CD4 T-cell counts and immune reconstitution in HIV-infected immune non-responders.
Conditions
- Human Immunodeficiency Virus
Interventions
- DRUG
-
TwHF
Taken oral, three times per day, at a dose of 20 mg/time for 48 weeks.
- DRUG
-
placebo treatment
Taken oral, three times per day, at a dose of 20 mg/time for 48 weeks.
Sponsors & Collaborators
-
Beijing 302 Hospital
lead OTHER
Principal Investigators
-
Fu-Sheng Wang, Professor · Beijing 302 Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-06-30
- Primary Completion
- 2016-12-31
- Completion
- 2016-12-31
Countries
- China
Study Locations
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