NCT02219672

Study on the Impact of Triptolide Woldifiion on HIV-1 Reservoir In Acute HIV-1 Infection

Study on the Impact of Triptolide Woldifiion on HIV-1 Reservoir of Chinese HIV/AIDS Patients In Acute HIV-1 Infection

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Peking Union Medical College · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	Triplitode	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 .
DRUG	Tenofovir plus lamivudine plus Lopinavir / ritonavir plus raltegravir	Participants who will be enrolled in this trial would be treated with Tenofovir plus lamivudine plus Lopinavir / ritonavir plus raltegravir.

Timeline

• Start date: 2014-07-01
• Primary completion: 2016-07-01
• Completion: 2017-07-01
• First posted: 2014-08-19
• Last updated: 2014-08-19

Locations

1 site across 1 country: China