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| Name | Class |
|---|---|
| Ministry of Science and Technology of the People´s Republic of China | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triptolide group | Experimental | cART for 6 months, and the experimental group will take Triplitode 2 tabs tid po for another 12 months |
|
| Comparator group | Active Comparator | combined antiretroviral therapy (cART): TDF+3TC+LPV/r+RAL for 18 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triplitode | Drug | 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 . |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of the immunologic response, virologic response, and hiv-1 reservoir | baseline and at Week 4, Week 12, Week 24, Week 36 follow-up visits |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events of the therapy | thirty-six months |
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Inclusion Criteria:
• age between 18-65 years
Exclusion Criteria:
Active opportunistic infection (not stable within 4 weeks 2 weeks ) or AIDS-related carcinoma;
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Lv, MD | Contact | 8610-69155046 | lvweipumch@163.com | |
| Fuping Guo, MD | Contact | 8610-69155046 | pumchguofp@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Taisheng Li, PhD | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100730 | China |
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| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| D019259 | Lamivudine |
| D061466 | Lopinavir |
| D019438 | Ritonavir |
| D000068898 | Raltegravir Potassium |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
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|
| Tenofovir plus lamivudine plus Lopinavir / ritonavir plus raltegravir | Drug | Participants who will be enrolled in this trial would be treated with Tenofovir plus lamivudine plus Lopinavir / ritonavir plus raltegravir. |
|
|
| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D015224 | Dideoxynucleosides |
| D011744 | Pyrimidinones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |