Human Immunodeficiency VirusPhase 1/2NCT01666990
Tripterygium Wilfordii Hook F (TwHF) Treatment for Immune Non-responders With HIV-1 Infection
A Phase 1/2 study testing TwHF in people with Human Immunodeficiency Virus, run by Beijing 302 Hospital at 2 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Human Immunodeficiency Virus
- What is being tested?
- TwHF
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- Jun 2012to Dec 2016
- Phase
- Phase 1/2
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- HIV infected
- antiretroviral therapy (ART) for at least 24 months prior to study entry and continue within the 12 months after study entry
- CD4 count less than or equal to 250 cells/mm3 continuously before entry and at screening, obtained within 30 days prior to study entry
- Viral load less than or equal to 400 copies/mL obtained within 30 days prior to study entry
- Certain specified laboratory values obtained within 30 days prior to study entry. More information on this criterion can be found in the study protocol.
- Documentation that pre-entry specimen for the primary immune activation endpoint responses has been obtained
Show all 9Show fewer
- No history of CDC category C AIDS-related opportunistic infections
- Karnofsky performance score greater than or equal to 70 within 30 days prior to study entry
- Ability and willingness to provide informed consent
Who cannot join
- Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to study entry
- Renal insufficiency, defined as serum creatinine greater than 1.5 mg/L, within 30 days prior to study entry
- History of retinal disease
- History of neoplasm other than localized squamous cell carcinoma of the skin
- History of cardiac conduction abnormality or cardiomyopathy. More information on this criterion can be found in the study protocol.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Beijing 302 Hospital
Beijing, Beijing Municipality, 100039
Zheng Zhang, Doctor, 86-10-63879735, zhangzheng1975@yahoo.com.cn
Fu-Sheng Wang, Professor
- Recruiting
the Yunnan Hospital of Infectious Diseases
Kunming, Yunnan, 650301
Xicheng Wang, Doctor, 86-0871-6256092, wxch62597@21cn.com
Xicheng Wang, Doctor
About this study
Official title: Phase 1/2 Study of Tripterygium Wilfordii Hook F (TwHF) Treatment for Evaluation the Efficacy and Safety in Immune Non-responders With HIV-1 Infection
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.
Read the detailed description
Although 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. In particular, this immune activation has been identified as a disease determinant independent of viral load or cell death in HIV-1 infection. A series of clinical evidences have indicated that activated CD8 T cells may attack body cells infected with viruses. Because of this, CD4 cells infected with HIV are frequently destroyed by CD8 cells.
In traditional Chinese medicine, extracts of the roots of the medicinal vine Tripterygium wilfordii Hook F (TwHF) (known in China as "lei gong teng" or "thunder god vine") have shown therapeutic promise in treating autoimmune and inflammatory conditions as well as cancer. In this extracts, three diterpenoids-triptolide, tripdiolide, and triptonide-are the most abundant and account for the immunosuppressive and anti-inflammatory effects observed in both in vitro and in vivo studies. Recently, different extracts of TwHF have been used in Chinese allopathic medicine for the treatment of autoimmune and inflammatory diseases, and small controlled trials reported good responses with TwHF extracts in patients with cadaveric kidney transplants and Crohn disease. In particular, a multicenter, double-blind, active comparator trial of a standardized TwHF extract in patients with active rheumatoid arthritis has shown a 20% improvement in American College of Rheumatology criteria in patients with TwHF than with sulfasalazine. Thus, TwHF may reduce inflammatory responses and promote tissue recovery in human diseases.
The purpose of this study is to learn whether and how well TwHF reduces the level of activation of CD8 cells in people infected with HIV. The decreased activation of CD8 cells may lead to a more CD4 T cell restoration and immune reconstitution in HIV infection. This study will also look at how well TwHF is tolerated and its safety in HIV- infected patients.
Participants in this study will be randomly assigned to one of two treatment arms:
Arm A: Participants will receive 48 weeks of TwHF treatment. Arm B: Participants will receive 48 weeks of placebo Study treatment will be given 20 mg, three times per day for a full 48 weeks. After treatment has started, participants will be asked to come to the clinic on Weeks 4, 8, 12, 16, 24, 36, and 48. At each visit participants will receive enough study treatment to last until the next visit. Each visit will last between 2 and 3 hours. At most visits participants will have a physical exam, answer questions about any medications they are taking and how they are feeling, and have blood drawn for safety to assess CD4/CD8 cell counts and viral load. Some additional blood will also be stored for immunology testing. At some visits participants will be asked questions about their medication and medical history, have pupils dilated, have a hearing test, and have an electrocardiogram (EKG). Some visits will require participants to arrive fasting. Pregnancy tests may also be conducted if the participant is able to become pregnant or if pregnancy is suspected.
- Conditions
- Human Immunodeficiency Virus
- Being tested
- TwHF, placebo treatment
- Keywords
- Tripterygium wilfordii Hook F (TwHF), HIV, CD4, immune over-activation
- 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.
TwHFDrug
Also called treatment
Taken oral, three times per day, at a dose of 20 mg/time for 48 weeks.
placebo treatmentDrug
Also called placebo
Taken oral, three times per day, at a dose of 20 mg/time for 48 weeks.
| Study group | Role | What they receive |
|---|---|---|
| TwHF, lifestyle counseling | Experimental | Participants will receive TwHF (20mg each time, 3 times per day, for 48 weeks) from Day 0 through the Week 48 study visit. Receives: Drug: TwHF |
| placebo, Lifestyle | Placebo comparator | Participants will receive placebo treatment (20mg each time, three times per day for 48 weeks) from Day 0 through the Week 48 study visit. Receives: Drug: placebo treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
the total CD4 T cell counts compared with CD4 T cell counts at baseline
Measured: At Baseline and at week 4, 8, 12, 24, 36 and 48
Secondary outcomes (17)
the CD38 expression on CD8 T cells
Measured: At Baseline and at week 4, 8, 12, 24, 36 and 48
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: at baseline and up to week 48
plasma RNA copies/mL
Measured: At Entry and at week 12 , 24 and 48
the ratio of CD4 and CD8 T cells
Measured: At baseline and at week 4, 8, 12, 24, 36 and 48
the total cell counts of peripheral CD3 T cells
Measured: At baseline and at week 4, 8, 12, 24, 36 and 48
the total cell counts of peripheral CD45RA+CCR7+ naive T cells
Measured: At baseline and at week 4, 8, 12, 24, 36 and 48
the cytokine levels of IL-1b in the plasma
Measured: At entry and at week 12, 24 and 48
the IL-2-producing T-cell number under stimulation with HIV Gag peptide pool
Measured: At entry and at week 12, 24 and 48
the HLA-DR expression on CD8 T cells
Measured: At Baseline and at week 4, 8, 12, 24, 36 and 48
the total cell number of peripheral CD8 T cells
Measured: At baseline and at week 4, 8, 12, 24, 36 and 48
the total cell counts of peripheral CD45RA+CCR7- central memory T cells
Measured: At baseline and at week 4, 8, 12, 24, 36 and 48
the total cell counts of peripheral CD45RA-CCR7- effector memory T cells
Measured: At baseline and at week 4, 8, 12, 24, 36 and 48
the cytokine levels of IL-6 in the plasma
Measured: At entry and at week 12, 24 and 48
the cytokine levels of TNF-a in the plasma
Measured: At entry and at week 12, 24 and 48
the levels of total IgG in the plasma
Measured: At entry and at week 12, 24 and 48
the cytokine levels of IFNa in the plasma
Measured: At entry and at week 12, 24 and 48
the IFN-g-producing T-cell number under stimulation with HIV Gag peptide pool
Measured: At entry and at week 12, 24 and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing 302 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fu-Sheng Wang, Professor, Principal investigator, Beijing 302 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01666990
- Sponsor's protocol ID
- Beijing302-007
- Status last verified
- Aug 2015
- First submitted
- 15 Aug 2012
- Last updated
- 17 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hammer SM, Squires KE, Hughes MD, Grimes JM, Demeter LM, Currier JS, Eron JJ Jr, Feinberg JE, Balfour HH Jr, Deyton LR, Chodakewitz JA, Fischl MA. A controlled trial of two nucleoside analogues plus indinavir in persons with human immunodeficiency virus infection and CD4 cell counts of 200 per cubic millimeter or less. AIDS Clinical Trials Group 320 Study Team. N Engl J Med. 1997 Sep 11;337(11):725-33. doi: 10.1056/NEJM199709113371101.
PubMed 9287227Mocroft A, Vella S, Benfield TL, Chiesi A, Miller V, Gargalianos P, d'Arminio Monforte A, Yust I, Bruun JN, Phillips AN, Lundgren JD. Changing patterns of mortality across Europe in patients infected with HIV-1. EuroSIDA Study Group. Lancet. 1998 Nov 28;352(9142):1725-30. doi: 10.1016/s0140-6736(98)03201-2.
PubMed 9848347Appay V, Sauce D. Immune activation and inflammation in HIV-1 infection: causes and consequences. J Pathol. 2008 Jan;214(2):231-41. doi: 10.1002/path.2276.
PubMed 18161758Li T, Wu N, Dai Y, Qiu Z, Han Y, Xie J, Zhu T, Li Y. Reduced thymic output is a major mechanism of immune reconstitution failure in HIV-infected patients after long-term antiretroviral therapy. Clin Infect Dis. 2011 Nov;53(9):944-51. doi: 10.1093/cid/cir552. Epub 2011 Sep 29.
PubMed 21960716Goldbach-Mansky R, Wilson M, Fleischmann R, Olsen N, Silverfield J, Kempf P, Kivitz A, Sherrer Y, Pucino F, Csako G, Costello R, Pham TH, Snyder C, van der Heijde D, Tao X, Wesley R, Lipsky PE. Comparison of Tripterygium wilfordii Hook F versus sulfasalazine in the treatment of rheumatoid arthritis: a randomized trial. Ann Intern Med. 2009 Aug 18;151(4):229-40, W49-51. doi: 10.7326/0003-4819-151-4-200908180-00005.
PubMed 19687490Kupchan SM, Court WA, Dailey RG Jr, Gilmore CJ, Bryan RF. Triptolide and tripdiolide, novel antileukemic diterpenoid triepoxides from Tripterygium wilfordii. J Am Chem Soc. 1972 Oct 4;94(20):7194-5. doi: 10.1021/ja00775a078. No abstract available.
PubMed 5072337Ji SM, Wang QW, Chen JS, Sha GZ, Liu ZH, Li LS. Clinical trial of Tripterygium Wilfordii Hook F. in human kidney transplantation in China. Transplant Proc. 2006 Jun;38(5):1274-9. doi: 10.1016/j.transproceed.2006.03.017.
PubMed 16797280Tao X, Lipsky PE. The Chinese anti-inflammatory and immunosuppressive herbal remedy Tripterygium wilfordii Hook F. Rheum Dis Clin North Am. 2000 Feb;26(1):29-50, viii. doi: 10.1016/s0889-857x(05)70118-6.
PubMed 10680192Qiu D, Zhao G, Aoki Y, Shi L, Uyei A, Nazarian S, Ng JC, Kao PN. Immunosuppressant PG490 (triptolide) inhibits T-cell interleukin-2 expression at the level of purine-box/nuclear factor of activated T-cells and NF-kappaB transcriptional activation. J Biol Chem. 1999 May 7;274(19):13443-50. doi: 10.1074/jbc.274.19.13443.
PubMed 10224109Tao X, Schulze-Koops H, Ma L, Cai J, Mao Y, Lipsky PE. Effects of Tripterygium wilfordii hook F extracts on induction of cyclooxygenase 2 activity and prostaglandin E2 production. Arthritis Rheum. 1998 Jan;41(1):130-8. doi: 10.1002/1529-0131(199801)41:13.0.CO;2-4.
PubMed 9433878
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2 Study of Tripterygium Wilfordii Hook F (TwHF) Treatment for Evaluation the Efficacy and Safety in Immune Non-responders With HIV-1 Infection
- ClinicalTrials.gov ID
- NCT01666990
- Acronym / sponsor ID
- Beijing302-007
- Conditions
- Human Immunodeficiency Virus
- Keywords
- Tripterygium wilfordii Hook F (TwHF), HIV, CD4, immune over-activation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beijing 302 HospitalUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 17 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Although 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. In particular, this immune activation has been identified as a disease determinant independent of viral load or cell death in HIV-1 infection. A series of clinical evidences have indicated that activated CD8 T cells may attack body cells infected with viruses. Because of this, CD4 cells infected with HIV are frequently destroyed by CD8 cells.
In traditional Chinese medicine, extracts of the roots of the medicinal vine Tripterygium wilfordii Hook F (TwHF) (known in China as "lei gong teng" or "thunder god vine") have shown therapeutic promise in treating autoimmune and inflammatory conditions as well as cancer. In this extracts, three diterpenoids-triptolide, tripdiolide, and triptonide-are the most abundant and account for the immunosuppressive and anti-inflammatory effects observed in both in vitro and in vivo studies. Recently, different extracts of TwHF have been used in Chinese allopathic medicine for the treatment of autoimmune and inflammatory diseases, and small controlled trials reported good responses with TwHF extracts in patients with cadaveric kidney transplants and Crohn disease. In particular, a multicenter, double-blind, active comparator trial of a standardized TwHF extract in patients with active rheumatoid arthritis has shown a 20% improvement in American College of Rheumatology criteria in patients with TwHF than with sulfasalazine. Thus, TwHF may reduce inflammatory responses and promote tissue recovery in human diseases.
The purpose of this study is to learn whether and how well TwHF reduces the level of activation of CD8 cells in people infected with HIV. The decreased activation of CD8 cells may lead to a more CD4 T cell restoration and immune reconstitution in HIV infection. This study will also look at how well TwHF is tolerated and its safety in HIV- infected patients.
Participants in this study will be randomly assigned to one of two treatment arms:
Arm A: Participants will receive 48 weeks of TwHF treatment. Arm B: Participants will receive 48 weeks of placebo Study treatment will be given 20 mg, three times per day for a full 48 weeks. After treatment has started, participants will be asked to come to the clinic on Weeks 4, 8, 12, 16, 24, 36, and 48. At each visit participants will receive enough study treatment to last until the next visit. Each visit will last between 2 and 3 hours. At most visits participants will have a physical exam, answer questions about any medications they are taking and how they are feeling, and have blood drawn for safety to assess CD4/CD8 cell counts and viral load. Some additional blood will also be stored for immunology testing. At some visits participants will be asked questions about their medication and medical history, have pupils dilated, have a hearing test, and have an electrocardiogram (EKG). Some visits will require participants to arrive fasting. Pregnancy tests may also be conducted if the participant is able to become pregnant or if pregnancy is suspected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TwHF, lifestyle counseling | Experimental | Drug: TwHFParticipants will receive TwHF (20mg each time, 3 times per day, for 48 weeks) from Day 0 through the Week 48 study visit. |
| placebo, Lifestyle | Placebo comparator | Drug: placebo treatmentParticipants will receive placebo treatment (20mg each time, three times per day for 48 weeks) from Day 0 through the Week 48 study visit. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- HIV infected
- antiretroviral therapy (ART) for at least 24 months prior to study entry and continue within the 12 months after study entry
- CD4 count less than or equal to 250 cells/mm3 continuously before entry and at screening, obtained within 30 days prior to study entry
- Viral load less than or equal to 400 copies/mL obtained within 30 days prior to study entry
- Certain specified laboratory values obtained within 30 days prior to study entry. More information on this criterion can be found in the study protocol.
Key exclusion criteria (5 listed)
- Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to study entry
- Renal insufficiency, defined as serum creatinine greater than 1.5 mg/L, within 30 days prior to study entry
- History of retinal disease
- History of neoplasm other than localized squamous cell carcinoma of the skin
- History of cardiac conduction abnormality or cardiomyopathy. More information on this criterion can be found in the study protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TwHFAlso: treatmentTaken oral, three times per day, at a dose of 20 mg/time for 48 weeks. | Drug | TwHF, lifestyle counseling |
| placebo treatmentAlso: placeboTaken oral, three times per day, at a dose of 20 mg/time for 48 weeks. | Drug | placebo, Lifestyle |
Primary outcome
the total CD4 T cell counts compared with CD4 T cell counts at baseline
Time frame: At Baseline and at week 4, 8, 12, 24, 36 and 48
17 secondary outcomes
the CD38 expression on CD8 T cells
Time frame: At Baseline and at week 4, 8, 12, 24, 36 and 48
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: at baseline and up to week 48
plasma RNA copies/mL
Time frame: At Entry and at week 12 , 24 and 48
the ratio of CD4 and CD8 T cells
Time frame: At baseline and at week 4, 8, 12, 24, 36 and 48
the total cell counts of peripheral CD3 T cells
Time frame: At baseline and at week 4, 8, 12, 24, 36 and 48
the total cell counts of peripheral CD45RA+CCR7+ naive T cells
Time frame: At baseline and at week 4, 8, 12, 24, 36 and 48
the cytokine levels of IL-1b in the plasma
Time frame: At entry and at week 12, 24 and 48
the IL-2-producing T-cell number under stimulation with HIV Gag peptide pool
Time frame: At entry and at week 12, 24 and 48
the HLA-DR expression on CD8 T cells
Time frame: At Baseline and at week 4, 8, 12, 24, 36 and 48
the total cell number of peripheral CD8 T cells
Time frame: At baseline and at week 4, 8, 12, 24, 36 and 48
the total cell counts of peripheral CD45RA+CCR7- central memory T cells
Time frame: At baseline and at week 4, 8, 12, 24, 36 and 48
the total cell counts of peripheral CD45RA-CCR7- effector memory T cells
Time frame: At baseline and at week 4, 8, 12, 24, 36 and 48
the cytokine levels of IL-6 in the plasma
Time frame: At entry and at week 12, 24 and 48
the cytokine levels of TNF-a in the plasma
Time frame: At entry and at week 12, 24 and 48
the levels of total IgG in the plasma
Time frame: At entry and at week 12, 24 and 48
the cytokine levels of IFNa in the plasma
Time frame: At entry and at week 12, 24 and 48
the IFN-g-producing T-cell number under stimulation with HIV Gag peptide pool
Time frame: At entry and at week 12, 24 and 48
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2015.
- Background: PubMed 9287227Hammer SM, Squires KE, Hughes MD, Grimes JM, Demeter LM, Currier JS, Eron JJ Jr, Feinberg JE, Balfour HH Jr, Deyton LR, Chodakewitz JA, Fischl MA. A controlled trial of two nucleoside analogues plus indinavir in persons with human immunodeficiency virus infection and CD4 cell counts of 200 per cubic millimeter or less. AIDS Clinical Trials Group 320 Study Team. N Engl J Med. 1997 Sep 11;337(11):725-33. doi: 10.1056/NEJM199709113371101.
- Background: PubMed 9848347Mocroft A, Vella S, Benfield TL, Chiesi A, Miller V, Gargalianos P, d'Arminio Monforte A, Yust I, Bruun JN, Phillips AN, Lundgren JD. Changing patterns of mortality across Europe in patients infected with HIV-1. EuroSIDA Study Group. Lancet. 1998 Nov 28;352(9142):1725-30. doi: 10.1016/s0140-6736(98)03201-2.
- Background: PubMed 18161758Appay V, Sauce D. Immune activation and inflammation in HIV-1 infection: causes and consequences. J Pathol. 2008 Jan;214(2):231-41. doi: 10.1002/path.2276.
- Background: PubMed 21960716Li T, Wu N, Dai Y, Qiu Z, Han Y, Xie J, Zhu T, Li Y. Reduced thymic output is a major mechanism of immune reconstitution failure in HIV-infected patients after long-term antiretroviral therapy. Clin Infect Dis. 2011 Nov;53(9):944-51. doi: 10.1093/cid/cir552. Epub 2011 Sep 29.
- Background: PubMed 19687490Goldbach-Mansky R, Wilson M, Fleischmann R, Olsen N, Silverfield J, Kempf P, Kivitz A, Sherrer Y, Pucino F, Csako G, Costello R, Pham TH, Snyder C, van der Heijde D, Tao X, Wesley R, Lipsky PE. Comparison of Tripterygium wilfordii Hook F versus sulfasalazine in the treatment of rheumatoid arthritis: a randomized trial. Ann Intern Med. 2009 Aug 18;151(4):229-40, W49-51. doi: 10.7326/0003-4819-151-4-200908180-00005.
- Background: PubMed 5072337Kupchan SM, Court WA, Dailey RG Jr, Gilmore CJ, Bryan RF. Triptolide and tripdiolide, novel antileukemic diterpenoid triepoxides from Tripterygium wilfordii. J Am Chem Soc. 1972 Oct 4;94(20):7194-5. doi: 10.1021/ja00775a078. No abstract available.
- Background: PubMed 16797280Ji SM, Wang QW, Chen JS, Sha GZ, Liu ZH, Li LS. Clinical trial of Tripterygium Wilfordii Hook F. in human kidney transplantation in China. Transplant Proc. 2006 Jun;38(5):1274-9. doi: 10.1016/j.transproceed.2006.03.017.
- Background: PubMed 10680192Tao X, Lipsky PE. The Chinese anti-inflammatory and immunosuppressive herbal remedy Tripterygium wilfordii Hook F. Rheum Dis Clin North Am. 2000 Feb;26(1):29-50, viii. doi: 10.1016/s0889-857x(05)70118-6.
- Background: PubMed 10224109Qiu D, Zhao G, Aoki Y, Shi L, Uyei A, Nazarian S, Ng JC, Kao PN. Immunosuppressant PG490 (triptolide) inhibits T-cell interleukin-2 expression at the level of purine-box/nuclear factor of activated T-cells and NF-kappaB transcriptional activation. J Biol Chem. 1999 May 7;274(19):13443-50. doi: 10.1074/jbc.274.19.13443.
- Background: PubMed 9433878Tao X, Schulze-Koops H, Ma L, Cai J, Mao Y, Lipsky PE. Effects of Tripterygium wilfordii hook F extracts on induction of cyclooxygenase 2 activity and prostaglandin E2 production. Arthritis Rheum. 1998 Jan;41(1):130-8. doi: 10.1002/1529-0131(199801)41:13.0.CO;2-4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fu-Sheng Wang, Professor principal investigator
Beijing 302 Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TwHF in people with Human Immunodeficiency Virus, run by Beijing 302 Hospital at 2 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 9 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 17 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zheng Zhang, Doctor (86-10-63879735, zhangzheng1975@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the total CD4 T cell counts compared with CD4 T cell counts at baseline (time frame: At Baseline and at week 4, 8, 12, 24, 36 and 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 NCT01666990, which also lists 10 linked publications.
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 17 Aug 2015.