AIDS/HIV PROBLEM
Conditions
Keywords
Triptolide wilfordii HIV-1 reservoir acute hiv infection
Brief 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.
Interventions
DRUGTriplitode
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 .
DRUGTenofovir 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.
Sponsors
Ministry of Science and Technology of the People´s Republic of China
Peking Union Medical College
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* • 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events of the therapy | thirty-six months |
Countries
China
Contacts
Primary ContactWei Lv, MD
Backup ContactFuping Guo, MD
Outcome results
None listed