NCT02002286

Pilot Study: Safety and Efficacy Study of Tripterygium Wilfordii Hook F Extract in cART-Treated HIV Patients With Poor Immune Responses

Completed NA Last updated 29 November 2013

What this trial tests

NA trial testing Tripterygium Wilfordii Hook F extract (TwHF extract) in HIV in 23 participants. Completed in 1 May 2013.

Timeline

1 August 2011

Primary endpoint
1 May 2013

1 May 2013

Quick facts

Lead sponsor	LI Taisheng
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	23
Start date	1 August 2011
Primary completion	1 May 2013
Estimated completion	1 May 2013
Sites	1 location across China

Drugs / interventions tested

• Tripterygium Wilfordii Hook F extract (TwHF extract) — full drug profile →
• cART — full drug profile →

Conditions studied

• HIV — all drugs for HIV →

Sponsor

LI Taisheng — full company profile →

Who can join

Adults 18 to 65, any sex, with HIV. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Changes of T cell subsets and immune activation markers
  Time frame: 12 months
  T cell subsets and activation biomarkers including CD4 count, memory and naive CD4 cell count, and CD38/HLA-DR expression will be monitored.

Sponsor's own description

This study is a pilot study to evaluate impact of Tripterygium Wilfordii Hook F (TwHF) on T cell immune activation and immune activation in HIV-infected immunological non-responders. The investigators aim to evaluate the safety and efficacy profiles of TwHF in HIV immunological non-responders.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. A comprehensive review of <i>Tripterygium wilfordii</i> hook. f. in the treatment of rheumatic and autoimmune diseases: Bioactive compounds, mechanisms of action, and future directions.
   Shan Y, Zhao J, Wei K, Jiang P, et al · · 2023 · cited 29× · PMID 38027004 · DOI 10.3389/fphar.2023.1282610
2. Tripterygium wilfordii Hook F extract in cART-treated HIV patients with poor immune response: a pilot study to assess its immunomodulatory effects and safety.
   Li T, Xie J, Li Y, Routy JP, et al · · 2015 · cited 20× · PMID 25874991 · DOI 10.1179/1528433614z.0000000005
3. The potential of plant systems to break the HIV-TB link.
   Habibi P, Daniell H, Soccol CR, Grossi-de-Sa MF. · · 2019 · cited 11× · PMID 30908823 · DOI 10.1111/pbi.13110
4. Triptolide-mediated immunomodulation of macrophages: from pathophysiology to therapy.
   Chen Y, Zhu Q, Yin A, Wang W, et al · · 2025 · cited 2× · PMID 41144250 · DOI 10.1080/07853890.2025.2575302
5. Pleiotropic pharmacological activities and multiple-organ toxicities of triptolide: a programmed cell death perspective
   Mao Y, Huang L, Long H, Huang Q, et al · · 2026