Acute HIV Infection Clinical Trial
Official title:
A Randomized, Open-label Trial to Compare the Efficacy and Safety of Early Initiation of cART With or Without Autologous HIV-1 Specific Cytotoxic T Lymphocyte (CTL) Infusion in Treatment-Naïve Acute HIV-1 Infected Adults
Verified date | April 2018 |
Source | Tang-Du Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to assess the ability of the early initiation of cART or cART in combination with autologous HIV-1 specific cytotoxic T lymphocyte (CTL) infusion to achieve a post-treatment control among treatment-naïve acute HIV-infected adults.
Status | Active, not recruiting |
Enrollment | 65 |
Est. completion date | December 2018 |
Est. primary completion date | August 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. Diagnosis of acute HIV infection (meets one of following criteria) 1. Negative for anti-HIV test formerly, but with an anti-HIV serological conversion within 6 months 2. Detection of plasma HIV RNA by RT-PCR in the absence of HIV antibody 3. Low-level of anti-HIV for BED HIV-1 capture enzyme immuno assay (BED-CEIA), optical density (OD)<0.6, only for B subtype) 4. Uncertain for an anti-HIV test, with an increasing anti-HIV level for repeated test within two weeks 5. A patient with a report of recent risk behavior in association with symptoms and signs of the acute retroviral syndrome, as well as a positive for HIV antigen detection and less than 4 bands in a Western blot assay 2. Ability, willingness to give informed consent 3. Able, willing to adhere to therapy and adherent to ART 4. Able, willing to comply with time requirements for study visits and evaluations Exclusion Criteria: 1. Chronic HIV - 1 infection 2. Any evidence of an active AIDS-defining opportunistic infection 3. Screening detects the following results:HGB<90g/L?WBC< 2 x 10E9/L?PLT< 75 x 10E9/L?hemodiastase>2 x ULN?Scr>1.5 x ULN?ALT/AST/ALP> 3 xULN?TbiL>2 xULN?CK>2 xULN?CCr<60ml/min 4. A personal history of clinically significant cardiac disease, symptomatic or asymptomatic arrhythmias, syncopal episodes, or additional risk factors for torsades de points 5. History of chronic kidney disease 6. History of malignancy or transplantation, including skin cancers or Kaposi sarcoma 7. History of Severe peptic ulcer 8. History of alcoholism and drug abuse 9. Receipt of immunomodulating agents, immunization or systemic chemotherapeutic agents within 28 days prior to screening 10. Women who are pregnant or breastfeeding, or with a positive pregnancy test during screening or Women of Child Bearing Potential (WOCBP) who are unwilling or unable to use an acceptable method of contraception to avoid pregnancy for the entire study period 11. Have contraindications to cART 12. Other condition that does not fit to participate in this study |
Country | Name | City | State |
---|---|---|---|
China | Beijing You'an Hospital, Capital Medical University | Beijing | Beijing |
China | National Center for STD and AIDS Control and Prevention, Chinese Center for Disease Control and Prevention | Beijing | Beijing |
China | Zhejiang University | Hangzhou | Zhejiang |
China | Shandong Center for Disease Control and Prevention | Jinan | Shandong |
China | The First Affiliated Hospital of Guangxi Medical University | Nanning | Guangxi |
China | China Medical University | Shenyang | Liaoning |
China | Department of Infectious Diseases, Tangdu Hospital, The Fourth Military Medical Universit | Xi'an | Shaanxi |
Lead Sponsor | Collaborator |
---|---|
Yongtao Sun, MD, PhD | Beijing YouAn Hospital, China Medical University, China, First Affiliated Hospital of Guangxi Medical University, National Center for AIDS/STD Control and Prevention, China CDC, Shandong Province Centers for Disease Control and Prevention, Tang-Du Hospital, Zhejiang University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in HIV DNA quantification at the interruption of cART | HIV DNA detection includes total HIV DNA, integrated HIV DNA , 2-long terminal repeat (LTR) HIV DNA in resting CD4+T cell subsets. | 48 weeks for Cohort 1, 72 weeks for Cohort 2, 96 weeks for Cohort 3 | |
Primary | Number of patients who achieve virological remission | Virological remission is defined as undetectable of plasma HIV RNA for 24 weeks after the interruption of cART. | 72 weeks for Cohort 1, 96 weeks for Cohort 2, 120 weeks for Cohort 3 | |
Secondary | Number of patients who occur any grade 3 or 4 (clinical or laboratory) adverse events | 120 weeks | ||
Secondary | Number of patients who need to initiate late treatment | Late treatment is defined cART should be administered according to local HIV treatment guidelines. | 120 weeks | |
Secondary | Time from cART interruption to virological relapse (plasma viral load more than 50 copies/mL) | 120 weeks | ||
Secondary | HIV-1 specific CD4+ and CD8+ T cell responses at week 120 | 120 weeks |
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