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HIV-infection/AIDSPhase 3NCT03403569

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

A Phase 3 study testing Triptolide Wilfordii in people with HIV-infection/AIDS, run by Peking Union Medical College Hospital at 7 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
HIV-infection/AIDS
What is being tested?
Triptolide Wilfordii
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
353 participants
Where
7 sitesChina
Study dates
1 Sep 2018to 30 Jun 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18~65 years old;
  • Male or female;
  • Good adherence and promise to follow-up;
  • Inform Consent signed;
  • Positive for HIV antibody test or serum HIV-RNA positive for 2 times or more;

Who cannot join

  • Present opportunity infection defined according to national AIDS treatment guideline or active opportunistic infection(not stable within 14 days ) within 3 months before recruitment or AIDS-related carcinoma;
  • Hemoglobin (HGB) < 9 g/dl, white blood cell (WBC) < 3000/ul, granulin (GRN) < 1500 /ul, platelet (PLT) < 75000 /ul, Cr >1.5x upper limit of normal (ULN), ALT or AST or alkaline phosphatase (ALP) >3x ULN, total bilirubin (TBIL) >2x ULN;
  • Pregnancy or breastfeeding;
  • Woman with pregnancy plan;
  • Severe organ dysfunction;
  • Administration of immunosuppressor, immunomodulator(including thymocin) or systemic cytotoxic drugs within 6 months before recruitment.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

China7 sites

  • Beijing YouAn Hospital, Capital Medical University

    Beijing, 100069

  • Beijing Ditan Hospital, Capital Medical University

    Beijing, 100191

  • Mengchao Hepatobiliary Hospital of Fujian Medical University

    Fuzhou, Fujian, 350025

  • The Eighth People's Hospital of Guangzhou

    Guangzhou, Guangdong, 510060

  • Xixi Hospital of Hangzhou

    Hangzhou, Zhejiang, 310023

  • The Fourth Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150001

  • The Sixth People's Hospital of Zhengzhou

    Zhengzhou, Henan, 450015

Other trials in China

About this study

Official title: Impact of Triptolide Wilfordii on Viral Suppression, Immune Recovery and Immune Activation Biomarkers in Treatment-naive HIV-1 Infection: a Randomized, Double-blinded, Placebo-controlled Study

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.

Read the detailed description

Acquired immune deficiency syndrome(AIDS) is a severe fatal disease caused by HIV infection. Despite viral suppression achieved, antiretroviral therapy(ART) cannot ameliorate HIV-induced immune activation and the consequent non-AIDS complications including cardiovascular, renal, hepatic diseases. Recently, immunosuppression therapy has become the focus since it can suppress exorbitant immune activation and inflammation so as to reduce the risk of non-AIDS cardiovascular and central neural system complications. Triptolide Wilfordii is a traditional Chinese herbal remedy and has long been used in the treatment of autoimmune diseases such as rheumatoid arthritis. Moreover, a recent study has shown that Triptolide Wilfordii combined with ART is associated with increased CD4 T cell counts and reduced immune activation in immunological non-responders, who were defined as patients with CD4 cell counts<350 cells/μl despite over 2 years of ART. Hence we expect Triptolide Wilfordii to bring up similar improvement in treatment naïve HIV infection. This randomized, double-blinded, placebo-controlled study is designed to investigate the safety and efficacy of Triptolide Wilfordii and hopefully provide evidence for a new treatment strategy.

Being tested
Triptolide Wilfordii, Placebo Oral Tablet
Keywords
CD4 cell recovery, immune activation, anti-inflammation
Medical subject headings
Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Triptolide WilfordiiDrug

    In addition to appropriate ART, Triptolide Wilfordii will be given to patients in the experimental group at a dosage of 20mg three times a day per os for 12 months.

  • Placebo Oral TabletDrug

    In addition to appropriate ART, placebo oral tablets will be given to patients in the experimental group at a dosage of 2 pills three times a day per os for 12 months.

Study groups in NCT03403569
Study groupRoleWhat they receive
Triptolide Wilfordii GroupExperimental150 patients will be enrolled and be administrated with Triptolide Wilfordii 20mg three times a day(TID) per os combined with appropriate ART for 12 months.
Receives: Drug: Triptolide Wilfordii
Placebo Oral Tablet GroupPlacebo comparator150 patients will be enrolled and be administrated with placebo per os combined with appropriate ART for 12 months.
Receives: Drug: Placebo Oral Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CD4 T cell counts and HIV RNA

    Compared to patients in placebo group, CD4 T cells of patients treated with Triptolide Wilfordii significantly increase and HIV RNA is reduced below 20 copies/ml.

    Measured: Baseline, Week4, Week12, Week24, Week36, Week 48

Secondary outcomes (3)

  1. Immune activation

    Compared to patients in placebo group, immune activation index of patients treated with Triptolide Wilfordii decreases.

    Measured: Baseline, Week4, Week12, Week24, Week36, Week 48

  2. Inflammation level

    Compared to patients in placebo group, inflammation level of patients treated with Triptolide Wilfordii decreases.

    Measured: Baseline, Week4, Week12, Week24, Week36, Week 48

  3. HIV reservoir

    Compared to patients in placebo group, HIV reservoir of patients treated with Triptolide Wilfordii is reduced.

    Measured: Baseline, Week4, Week12, Week24, Week36, Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2018
  2. Study start1 Sep 2018
  3. Primary completion30 Jun 2021
  4. Study completion30 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
353 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03403569
Sponsor's protocol ID
PekingUMCH record JS-985
Status last verified
Mar 2020
First submitted
11 Jan 2018
Last updated
8 Apr 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Triptolide Wilfordii in people with HIV-infection/AIDS, run by Peking Union Medical College Hospital at 7 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CD4 T cell counts and HIV RNA (time frame: Baseline, Week4, Week12, Week24, Week36, Week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03403569.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2022.

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