Tripterygium Wilfordii Hook F (TwHF) Treatment for Immune Non-responders With HIV-1 Infection

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing 302 Hospital

Criteria

Inclusion Criteria:

1. HIV infected

2. antiretroviral therapy (ART) for at least 24 months prior to study entry and continue within the 12 months after study entry

3. CD4 count less than or equal to 250 cells/mm3 continuously before entry and at screening, obtained within 30 days prior to study entry

4. Viral load less than or equal to 400 copies/mL obtained within 30 days prior to study entry

5. Certain specified laboratory values obtained within 30 days prior to study entry. More information on this criterion can be found in the study protocol.

6. Documentation that pre-entry specimen for the primary immune activation endpoint responses has been obtained

7. No history of CDC category C AIDS-related opportunistic infections

8. Karnofsky performance score greater than or equal to 70 within 30 days prior to study entry

9. Ability and willingness to provide informed consent

Exclusion Criteria:

1. Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to study entry

2. Renal insufficiency, defined as serum creatinine greater than 1.5 mg/L, within 30 days prior to study entry

3. History of retinal disease

4. History of neoplasm other than localized squamous cell carcinoma of the skin

5. History of cardiac conduction abnormality or cardiomyopathy. More information on this criterion can be found in the study protocol.