NCT03403569

Safety and Efficacy of Triptolide Wilfordii in New Onset HIV-1 Infection

Completed Phase 3 Last updated 8 April 2022

What this trial tests

Phase 3 trial testing Triptolide Wilfordii in HIV-infection/AIDS in 353 participants. Completed in 30 June 2021.

Timeline

1 September 2018

Primary endpoint
30 June 2021

30 June 2021

Quick facts

Lead sponsor	Peking Union Medical College Hospital
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	353
Start date	1 September 2018
Primary completion	30 June 2021
Estimated completion	30 June 2021
Sites	7 locations across China

Drugs / interventions tested

• Triptolide Wilfordii — full drug profile →
• Placebo Oral Tablet — full drug profile →

Conditions studied

• HIV-infection/AIDS — all drugs for HIV-infection/AIDS →

Sponsor

Peking Union Medical College Hospital

Who can join

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

Sponsor's own description

The traditional Chinese herbal medicine Triptolide Wilfordii has displayed remarkable effect on the treatment of autoimmune diseases such as rheumatoid arthritis. Now that immunosuppression therapy has recently become a new strategy for HIV infection, it's reasonable to expect the anti-inflammatory effect of Triptolide Wilfordii in HIV infected patients. So we designed a randomized, double-blinded, placebo-controlled study to explore the efficacy and safety of Triptolide Wilfordii in new-onset HIV infection.

Publications & conference data

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

1. Tat-Based Therapies as an Adjuvant for an HIV-1 Functional Cure.
   Jin H, Li D, Lin MH, Li L, et al · · 2020 · cited 21× · PMID 32276443 · DOI 10.3390/v12040415
2. Forging a Functional Cure for HIV: Transcription Regulators and Inhibitors.
   Mediouni S, Lyu S, Schader SM, Valente ST. · · 2022 · cited 19× · PMID 36146786 · DOI 10.3390/v14091980
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