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

Peking Union Medical College

Status and phase: Unknown; Phase 3

Conditions: AIDS/HIV PROBLEM

Treatments: Drug: Triplitode; Drug: Tenofovir plus lamivudine plus Lopinavir / ritonavir plus raltegravir

Study type: Interventional

Funder types: Other

Identifiers

NCT02219672

CACT140816

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Triptolide group

Experimental group

Description:

cART for 6 months, and the experimental group will take Triplitode 2 tabs tid po for another 12 months

Treatment:

Drug: Triplitode

Comparator group

Active Comparator group

Description:

combined antiretroviral therapy (cART): TDF+3TC+LPV/r+RAL for 18 months

Treatment:

Drug: Tenofovir plus lamivudine plus Lopinavir / ritonavir plus raltegravir