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Early cART and cART in Combination With Autologous HIV-1 Specific Cytotoxic T Lymphocyte (CTL) Infusion in The Treatment of Acute HIV-1 Infected Adults

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2014 by Yongtao Sun, MD, PhD, Tang-Du Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02231281
First Posted: September 4, 2014
Last Update Posted: September 4, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Tang-Du Hospital
National Center for AIDS/STD Control and Prevention, China CDC
Beijing YouAn Hospital
China Medical University, China
Shandong Province Centers for Disease Control and Prevention
Zhejiang University
Guangxi Medical University
Information provided by (Responsible Party):
Yongtao Sun, MD, PhD, Tang-Du Hospital
  Purpose
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.

Condition Intervention Phase
Acute HIV Infection Drug: cART(TDF/AZT+3TC+LPV/r) Procedure: CTL infusion Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Yongtao Sun, MD, PhD, Tang-Du Hospital:

Primary Outcome Measures:
  • Change from baseline in HIV DNA quantification at the interruption of cART [ Time Frame: 48 weeks for Cohort 1, 72 weeks for Cohort 2, 96 weeks for Cohort 3 ]
    HIV DNA detection includes total HIV DNA, integrated HIV DNA , 2-long terminal repeat (LTR) HIV DNA in resting CD4+T cell subsets.

  • Number of patients who achieve virological remission [ Time Frame: 72 weeks for Cohort 1, 96 weeks for Cohort 2, 120 weeks for Cohort 3 ]
    Virological remission is defined as undetectable of plasma HIV RNA for 24 weeks after the interruption of cART.


Secondary Outcome Measures:
  • Number of patients who occur any grade 3 or 4 (clinical or laboratory) adverse events [ Time Frame: 120 weeks ]
  • Number of patients who need to initiate late treatment [ Time Frame: 120 weeks ]
    Late treatment is defined cART should be administered according to local HIV treatment guidelines.

  • Time from cART interruption to virological relapse (plasma viral load more than 50 copies/mL) [ Time Frame: 120 weeks ]
  • HIV-1 specific CD4+ and CD8+ T cell responses at week 120 [ Time Frame: 120 weeks ]

Estimated Enrollment: 65
Study Start Date: August 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cART(TDF/AZT+3TC+LPV/r)
cART(TDF/AZT+3TC+LPV/r)
Drug: cART(TDF/AZT+3TC+LPV/r)
Standard antiretroviral therapy for HIV infection
Other Names:
  • Tenofovir Disoproxil Fumarate
  • Zidovudine
  • Lamivudine
  • Lopinavir/ritonavir (Kaletra)
Experimental: CTL infusion
cART plus autologous HIV-1 specific cytotoxic T lymphocyte (CTL) infusion
Drug: cART(TDF/AZT+3TC+LPV/r)
Standard antiretroviral therapy for HIV infection
Other Names:
  • Tenofovir Disoproxil Fumarate
  • Zidovudine
  • Lamivudine
  • Lopinavir/ritonavir (Kaletra)
Procedure: CTL infusion
cART(TDF/AZT+3TC+LPV/r) plus autologous HIV-1 specific cytotoxic T lymphocyte (CTL) infusion

Detailed Description:

Although combined antiretroviral therapy (cART) can suppress HIV-1 replication to a very low level in the blood, but it cannot eliminate latent viral reservoirs, and need lifelong adherence to expensive regimens that have potential side effects. Increasing evidence indicates that early antiretroviral therapy for recently HIV-infected patients results in slower progression of HIV disease and represent a unique opportunity to interfere with either the quantities or qualities of persistent reservoirs of replication-competent virus. However, the time course before the interruption of cART is unclear. This study will compare the virological and immunological outcomes and HIV latency of recently infected adults who receive cART or cART in combination with autologous HIV-1 CTL infusion for different periods.

The study will last 120 weeks. Participants will be randomly assigned to either the cART or the cART plus autologous HIV-1 CTL infusion arm of one of three cohorts. The three cohorts will differ in the period of cART given. Cohort 1, Cohort 2 or Cohort 3 will receive cART (Zidovudine (AZT)/Tenofovir disoproxil fumarate (TDF) +Lamivudine (3TC) + Lopinavir / Ritonavir (LPV/r)) for 48, 72 or 96 weeks, respectively. After 48, 72 or 96 weeks, cART will be interrupted respectively. Study visits will occur at study entry, Week 4 and 12, and every 12 weeks thereafter through treatment interruption, then every 4 weeks through 12 weeks later, then every 12 weeks through Week 120. At each study visit, a physical exam, blood collection, and completion of an adherence questionnaire will occur. Clinical, virological, and immunological evaluations and HIV latency examination will be performed at most study visit.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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): NCT02231281


Contacts
Contact: Yongtao Sun, M.D., Ph.D. 862984777960 yongtaos@hotmail.com
Contact: Wen Kang, M.D., Ph.D. 86-13679292957 kangwenkevin@gmail.com

Locations
China, Beijing
Beijing You'an Hospital, Capital Medical University Recruiting
Beijing, Beijing, China
Contact: Hao Wu, M.D., Ph.D.    8610-63053963      
Principal Investigator: Hao Wu, M.D., Ph.D.         
National Center for STD and AIDS Control and Prevention, Chinese Center for Disease Control and Prevention Recruiting
Beijing, Beijing, China
Contact: Fujie Zhang, M.D., Ph.D.         
Principal Investigator: Fujie Zhang, M.D., Ph.D.         
China, Guangxi
The First Affiliated Hospital of Guangxi Medical University Recruiting
Nanning, Guangxi, China
Contact: Jianning Jiang, M.D.    86771-5356531      
Principal Investigator: Jianning Jiang, M.D.         
China, Liaoning
China Medical University Recruiting
Shenyang, Liaoning, China
Contact: Yongjun Jiang, M.D.         
Principal Investigator: Yongjun Jiang, M.D.         
China, Shaanxi
Department of Infectious Diseases, Tangdu Hospital, The Fourth Military Medical Universit Recruiting
Xi'an, Shaanxi, China, 710038
Contact: Yongtao , Sun    8629-84777960    yongtaos@hotmail.com   
Contact: Wen , Kang    86-13679292957    kangwenkevin@gmail.com   
Principal Investigator: Yongtao Sun, M.D., Ph.D.         
China, Shandong
Shandong Center for Disease Control and Prevention Recruiting
Jinan, Shandong, China
Contact: Dianmin Kang, Ph.D.    86531-82679612      
Principal Investigator: Dianmin Kang, Ph.D.         
China, Zhejiang
Zhejiang University Recruiting
Hangzhou, Zhejiang, China
Contact: Biao Zhu, M.D., Ph.D.         
Principal Investigator: Biao Zhu, M.D., Ph.D.         
Sponsors and Collaborators
Yongtao Sun, MD, PhD
Tang-Du Hospital
National Center for AIDS/STD Control and Prevention, China CDC
Beijing YouAn Hospital
China Medical University, China
Shandong Province Centers for Disease Control and Prevention
Zhejiang University
Guangxi Medical University
Investigators
Principal Investigator: Yongtao Sun, M.D., Ph.D. Department of Infectious Diseases, Tangdu Hospital, The Fourth Military Medical University
  More Information

Responsible Party: Yongtao Sun, MD, PhD, Director of Department of Infectious Diseases, Tang-Du Hospital
ClinicalTrials.gov Identifier: NCT02231281     History of Changes
Other Study ID Numbers: 2014ZX10001002-001
2014ZX10001002-001 ( Other Grant/Funding Number: National Science and Technology Major Project of China during the "12th Five-Year Plan" )
First Submitted: August 26, 2014
First Posted: September 4, 2014
Last Update Posted: September 4, 2014
Last Verified: September 2014

Keywords provided by Yongtao Sun, MD, PhD, Tang-Du Hospital:
HIV Infections
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
Virus Diseases
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Therapeutic Uses
Pharmacologic Actions
Antiretroviral therapy
Early therapy

Additional relevant MeSH terms:
Infection
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Tenofovir
Lopinavir
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
HIV Protease Inhibitors
Protease Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors