Trials / Completed
CompletedNCT04084444
Safety and Efficacy of T8 on Treating Chronic Abnormal Immune Activation in HIV/AIDS Patients
Efficacy and Safety of T8 on Treating Chronic Abnormal Immune Activation in HIV/AIDS Patients: A Multicenter, Randomized, Double-blind, Dose-finding, Placebo-controlled Study
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 151 (actual)
- Sponsor
- Shanghai Pharmaceuticals Holding Co., Ltd · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This is a multicenter, randomized, double-blind, dose-finding, placebo-controlled study in patients with chronic HIV infection and inadequate immune restoration treated with long-term highly active antiretroviral therapy (HAART). A total of 150 eligible subjects will be selected and randomized at a ratio of 1:1:1 into T8 0.5 mg QD, 1 mg QD, and placebo group, with background HAART unchanged, for 48 consecutive weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | T8 tablet 0.5mg | Immune regulation, inhibition of acute nonspecific inflammation and chronic inflammation. |
| DRUG | T8 tablet 1mg | Immune regulation, inhibition of acute nonspecific inflammation and chronic inflammation. |
| DRUG | Placebo | Blank control. |
Timeline
- Start date
- 2019-12-25
- Primary completion
- 2022-07-05
- Completion
- 2022-07-05
- First posted
- 2019-09-10
- Last updated
- 2023-03-31
Locations
9 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04084444. Inclusion in this directory is not an endorsement.