Safety and Efficacy Study of TwHF in HIV Patients With Poor Immune Responses

NCT02002286 | Completed DMC

• 1 other identifier: TwHF Pilot
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV

Keywords

HIV-infected immunological non-responders; Tripterygium Wilfordii Hook F; Immune activation

Outcome Measures

Primary Outcomes (1)

• Changes of T cell subsets and immune activation markers

  T cell subsets and activation biomarkers including CD4 count, memory and naive CD4 cell count, and CD38/HLA-DR expression will be monitored.

  12 months

Secondary Outcomes (2)

• Viral load

  12 months

• Number of participants with adverse events as a measure of safety and tolerability

  12 months

Study Arms (2)

TwHF extract + cART

EXPERIMENTAL

Use Tripterygium Wilfordii Hook F extract (TwHF extract) and continue current cART regimen

Drug: Tripterygium Wilfordii Hook F extract (TwHF extract); Drug: cART

cART control

OTHER

Continue current cART regimen

Drug: cART

Interventions

Tripterygium Wilfordii Hook F extract (TwHF extract) DRUG

The extract Tripterygium wilfordii Hook F (TwHF), a traditional Chinese medication, has been used as anti-inflammatory therapy to treat autoimmune diseases including rheumatoid arthritis and Crohn's disease.

Also known as: Triptolide Wilfordii

TwHF extract + cART

cART DRUG

Participants who will be enrolled in this trial would keep their previous combined antiretroviral therapy, such as zidovudine or stavudine plus lamivudine plus nevirapine or efavirenz.

Also known as: Combination antiretroviral therapy

TwHF extract + cART; cART control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Continuous antiretroviral therapy \> 18 months, and consistent HIV-RNA\< 40 copies/mL more than 12 months;
• years old;
• Male or female;
• Good adherence and promise to follow-up;
• Inform Consent signed;
• CD4 T cells less than 300/ul .

You may not qualify if:

• Active opportunistic infection (not stable within 4 weeks 2 weeks ) or AIDS-related carcinoma;
• Hemoglobin (HGB) \< 9 g/dl, white blood cell (WBC) \< 2000/ul, granulin (GRN) \< 1000 /ul, platelet (PLT) \< 75000 /ul, Cr \>1.5x ULN, ALT or AST or alkaline phosphatase (ALP) \>3x upper limit of normal (ULN), total bilirubin (TBIL) \>2x ULN, creatine kinase (CK) \> 2x ULN;
• Pregnant or breastfeeding woman or woman with pregnancy plan;
• Active drug-user;
• Severe neurological defects;
• Active alcohol abuse;
• Severe gastrointestinal ulcer .
• End-stage disease such as cirrhosis, chronic obstructive pulmonary disease, congestive heart failure, recent myocardial ischemia,tumor, etc Those who are undertaking steroids, immunomodulator, anti-inflammatory agents

Sponsors & Collaborators

• LI Taisheng: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, 100730, China

Location

Related Publications (3)

• Piconi S, Parisotto S, Rizzardini G, Passerini S, Terzi R, Argenteri B, Meraviglia P, Capetti A, Biasin M, Trabattoni D, Clerici M. Hydroxychloroquine drastically reduces immune activation in HIV-infected, antiretroviral therapy-treated immunologic nonresponders. Blood. 2011 Sep 22;118(12):3263-72. doi: 10.1182/blood-2011-01-329060. Epub 2011 May 16.

  PMID: 21576701 BACKGROUND

• Murray SM, Down CM, Boulware DR, Stauffer WM, Cavert WP, Schacker TW, Brenchley JM, Douek DC. Reduction of immune activation with chloroquine therapy during chronic HIV infection. J Virol. 2010 Nov;84(22):12082-6. doi: 10.1128/JVI.01466-10. Epub 2010 Sep 15.

  PMID: 20844049 BACKGROUND

• Li T, Xie J, Li Y, Routy JP, Li Y, Han Y, Qiu Z, Lv W, Song X, Sun M, Zhang X, Wang F, Jiang H. Tripterygium wilfordii Hook F extract in cART-treated HIV patients with poor immune response: a pilot study to assess its immunomodulatory effects and safety. HIV Clin Trials. 2015 Mar-Apr;16(2):49-56. doi: 10.1179/1528433614Z.0000000005. Epub 2015 Jan 26.

  PMID: 25874991 DERIVED

MeSH Terms

Interventions

Antiretroviral Therapy, Highly Active

Intervention Hierarchy (Ancestors)

Drug Therapy, Combination; Drug Therapy; Therapeutics

Study Officials

• Taisheng Li, MD, PhD

  Department of Infectious Diseases, Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 18, 2013
• First Posted: December 5, 2013
• Study Start: August 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: December 5, 2013

Record last verified: 2013-11

Locations

CN (1)