Study on the Impact of Triptolide Woldifiion on HIV-1 Reservoir In Acute HIV-1 Infection
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|ClinicalTrials.gov Identifier: NCT02219672|
Recruitment Status : Unknown
Verified August 2014 by LI Taisheng, Peking Union Medical College.
Recruitment status was: Recruiting
First Posted : August 19, 2014
Last Update Posted : August 19, 2014
|Condition or disease||Intervention/treatment||Phase|
|AIDS/HIV PROBLEM||Drug: Triplitode Drug: Tenofovir plus lamivudine plus Lopinavir / ritonavir plus raltegravir||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study on the Impact of Triptolide Woldifiion on HIV-1 Reservoir of Chinese HIV/AIDS Patients In Acute HIV-1 Infection|
|Study Start Date :||July 2014|
|Estimated Primary Completion Date :||July 2016|
|Estimated Study Completion Date :||July 2017|
Experimental: Triptolide group
cART for 6 months, and the experimental group will take Triplitode 2 tabs tid po for another 12 months
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 .
Other Name: Triptolide Wilfordii
Active Comparator: Comparator group
combined antiretroviral therapy (cART): TDF+3TC+LPV/r+RAL for 18 months
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.
Other Name: 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02219672
|Contact: Wei Lv, MDfirstname.lastname@example.org|
|Contact: Fuping Guo, MDemail@example.com|
|Peking Union Medical College Hospital||Recruiting|
|Beijing, Beijing, China, 100730|
|Contact: Fuping Guo, MD 86-10-69155082 firstname.lastname@example.org|
|Principal Investigator: Taisheng Li, PhD|
|Principal Investigator:||Taisheng Li, PhD||Peking Union Medical College Hospital|