A Phase 3 interventional study of Triplitode and Tenofovir plus lamivudine plus Lopinavir / ritonavir plus raltegravir in AIDS/HIV PROBLEM, sponsored by Peking Union Medical College. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-08-19.
Sponsored by Peking Union Medical College · Phase 3, Interventional, and Prevention
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 18 is below the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Peking Union Medical College is the lead sponsor of 58 studies on the registry; 17 are open to participants now.
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age between 18-65 years
Exclusion Criteria:
Active opportunistic infection (not stable within 4 weeks 2 weeks ) or AIDS-related carcinoma;
cART for 6 months, and the experimental group will take Triplitode 2 tabs tid po for another 12 months
Drug: Triplitode
combined antiretroviral therapy (cART): TDF+3TC+LPV/r+RAL for 18 months
Drug: Tenofovir plus lamivudine plus Lopinavir / ritonavir plus raltegravir
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 .
Also known as: Triptolide Wilfordii
Participants who will be enrolled in this trial would be treated with Tenofovir plus lamivudine plus Lopinavir / ritonavir plus raltegravir.
Also known as: TDF+3TC+LPV/r+RAL for 18 months
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
Adverse events of the therapy
Time frame: thirty-six months
This study is status unknown, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.
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Peking Union Medical College