AIDS/HIV PROBLEMPhase 3NCT02219672
Study on the Impact of Triptolide Woldifiion on HIV-1 Reservoir In Acute HIV-1 Infection
A Phase 3 study testing Triplitode and Tenofovir plus lamivudine plus Lopinavir / ritonavir plus raltegravir in people with AIDS/HIV PROBLEM, run by Peking Union Medical College at 1 site in China.
Trial summary
This study is a prospective trial which will recruit 18 patients in acute HIV-1 infection phase. This study aims to evaluate the effects and side effects of ARV treatment in Chinese patients in acute HIV-1 infection phase, and to evaluate the impact of Triptolide wilfordii on HIV-1 reservoir. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- AIDS/HIV PROBLEM
- What is being tested?
- Triplitode and Tenofovir plus lamivudine plus Lopinavir / ritonavir plus raltegravir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- Jul 2014to Jul 2017
- 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
- • age between 18-65 years
- HIV seropositive and confirmed by western blot, confirmed as acute HIV-1 infection
- good adherence and follow up in the same place
- Inform Consent signed
- ART-naïve
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Fuping Guo, MD, 86-10-69155082, pumchguofp@163.com
Taisheng Li, PhD
About this study
Official title: Study on the Impact of Triptolide Woldifiion on HIV-1 Reservoir of Chinese HIV/AIDS Patients In Acute HIV-1 Infection
This study is a prospective trial which will recruit 18 patients in acute HIV-1 infection phase. This study aims to evaluate the effects and side effects of ARV treatment in Chinese patients in acute HIV-1 infection phase, and to evaluate the impact of Triptolide wilfordii on HIV-1 reservoir.
Read the detailed description
Two arms will be enrolled in this study, 18 naive-treatment Chinese patients in acute HIV-1 infection phase would be allocated to two arms, and treated with the antiretroviral drugs (Tenofovir plus lamivudine plus Lopinavir / ritonavir plus raltegravir). Six months later, 12 patients will be treated with Triplitode, in order to observe the impact of of Triptolide wilfordii on HIV-1 reservoir of patients in acute infection phase. All patients should be explored for 18 months in terms of the clinical features, drugs side-effects, and immunological and viral response, and the HIV-1 reservoir. We hypothesis that Triptolide wilfordii might further reduce the HIV-1 reservoir. The result would provide proofs for further practical antiviral therapy for patients in acute infection phase in China or other resource limited countries.
- Conditions
- AIDS/HIV PROBLEM
- Being tested
- Triplitode, Tenofovir plus lamivudine plus Lopinavir / ritonavir plus raltegravir
- Keywords
- Triptolide wilfordii HIV-1 reservoir acute hiv infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriplitodeDrug
Also called Triptolide Wilfordii
Drug: Triptolide Triptolide Wilfordii is a Chinese old herb which is widely used as a remedy for rheumatic diseases and nephropathy in China. It is approved that it can play a role as an immune modular.
Other Name: Tripterygium Wilfordii Hook F (TwHF) Drug: cART Participants who will be enrolled in this Triplitode group would be treated with Tenofovir plus lamivudine plus Lopinavir / ritonavir plus raltegravir .
Tenofovir plus lamivudine plus Lopinavir / ritonavir plus raltegravirDrug
Also called TDF+3TC+LPV/r+RAL for 18 months
Participants who will be enrolled in this trial would be treated with Tenofovir plus lamivudine plus Lopinavir / ritonavir plus raltegravir.
| Study group | Role | What they receive |
|---|---|---|
| Triptolide group | Experimental | cART for 6 months, and the experimental group will take Triplitode 2 tabs tid po for another 12 months Receives: Drug: Triplitode |
| Comparator group | Active comparator | combined antiretroviral therapy (cART): TDF+3TC+LPV/r+RAL for 18 months Receives: Drug: Tenofovir plus lamivudine plus Lopinavir / ritonavir plus raltegravir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of the immunologic response, virologic response, and hiv-1 reservoir
Measured: baseline and at Week 4, Week 12, Week 24, Week 36 follow-up visits
Secondary outcomes (1)
Adverse events of the therapy
Measured: thirty-six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2016 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AIDS/HIV PROBLEMStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology of the People´s Republic of China
- Responsible party
- Principal investigator, LI Taisheng, Peking Union Medical College
- Investigators
- Taisheng Li, PhD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02219672
- Sponsor's protocol ID
- CACT140816
- Status last verified
- Aug 2014
- First submitted
- 16 Aug 2014
- Last updated
- 19 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Impact of Triptolide Woldifiion on HIV-1 Reservoir of Chinese HIV/AIDS Patients In Acute HIV-1 Infection
- ClinicalTrials.gov ID
- NCT02219672
- Acronym / sponsor ID
- CACT140816
- Conditions
- AIDS/HIV PROBLEM
- Keywords
- Triptolide wilfordii HIV-1 reservoir acute hiv infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Peking Union Medical CollegeUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology of the People´s Republic of China
- Study start
- Jul 2014
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 19 Aug 2014 (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.
This study is a prospective trial which will recruit 18 patients in acute HIV-1 infection phase. This study aims to evaluate the effects and side effects of ARV treatment in Chinese patients in acute HIV-1 infection phase, and to evaluate the impact of Triptolide wilfordii on HIV-1 reservoir.
Detailed description
Two arms will be enrolled in this study, 18 naive-treatment Chinese patients in acute HIV-1 infection phase would be allocated to two arms, and treated with the antiretroviral drugs (Tenofovir plus lamivudine plus Lopinavir / ritonavir plus raltegravir). Six months later, 12 patients will be treated with Triplitode, in order to observe the impact of of Triptolide wilfordii on HIV-1 reservoir of patients in acute infection phase. All patients should be explored for 18 months in terms of the clinical features, drugs side-effects, and immunological and viral response, and the HIV-1 reservoir. We hypothesis that Triptolide wilfordii might further reduce the HIV-1 reservoir. The result would provide proofs for further practical antiviral therapy for patients in acute infection phase in China or other resource limited countries.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triptolide group | Experimental | Drug: TriplitodecART for 6 months, and the experimental group will take Triplitode 2 tabs tid po for another 12 months |
| Comparator group | Active comparator | Drug: Tenofovir plus lamivudine plus Lopinavir / ritonavir plus raltegravircombined antiretroviral therapy (cART): TDF+3TC+LPV/r+RAL for 18 months |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- • age between 18-65 years
Key exclusion criteria (8 listed)
- Active opportunistic infection (not stable within 4 weeks 2 weeks ) or AIDS-related carcinoma;
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 |
|---|---|---|
| TriplitodeAlso: Triptolide WilfordiiDrug: Triptolide Triptolide Wilfordii is a Chinese old herb which is widely used as a remedy for rheumatic diseases and nephropathy in China. It is approved that it can play a role as an immune modular. Other Name: Tripterygium Wilfordii Hook F (TwHF) Drug: cART Participants who will be enrolled in this Triplitode group would be treated with Tenofovir plus lamivudine plus Lopinavir / ritonavir plus raltegravir . | Drug | Triptolide group |
| Tenofovir plus lamivudine plus Lopinavir / ritonavir plus raltegravirAlso: TDF+3TC+LPV/r+RAL for 18 monthsParticipants who will be enrolled in this trial would be treated with Tenofovir plus lamivudine plus Lopinavir / ritonavir plus raltegravir. | Drug | Comparator group |
Primary outcome
Changes of the immunologic response, virologic response, and hiv-1 reservoir
Time frame: baseline and at Week 4, Week 12, Week 24, Week 36 follow-up visits
1 secondary outcome
Adverse events of the therapy
Time frame: thirty-six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2014.
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.
Taisheng Li, PhD principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Triplitode and Tenofovir plus lamivudine plus Lopinavir / ritonavir plus raltegravir in people with AIDS/HIV PROBLEM, run by Peking Union Medical College at 1 site 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 8 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 19 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Lv, MD (8610-69155046, lvweipumch@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of the immunologic response, virologic response, and hiv-1 reservoir (time frame: baseline and at Week 4, Week 12, Week 24, Week 36 follow-up visits). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2014.