A Phase 3 interventional study of cART(TDF/AZT+3TC+LPV/r) and CTL infusion in Acute HIV Infection, sponsored by Yongtao Sun, MD, PhD. Status unknown at 7 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-04-26.
Sponsored by Yongtao Sun, MD, PhD · Phase 3, Interventional, and Treatment
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.
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 65 is below the median of 120 across 4,200 interventional studies indexed under Infections.
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Diagnosis of acute HIV infection (meets one of following criteria)
Exclusion Criteria:
cART(TDF/AZT+3TC+LPV/r)
Drug: cART(TDF/AZT+3TC+LPV/r)
cART plus autologous HIV-1 specific cytotoxic T lymphocyte (CTL) infusion
Drug: cART(TDF/AZT+3TC+LPV/r) · Procedure: CTL infusion
Standard antiretroviral therapy for HIV infection
Also known as: Tenofovir Disoproxil Fumarate, Zidovudine, Lamivudine, Lopinavir/ritonavir (Kaletra)
cART(TDF/AZT+3TC+LPV/r) plus autologous HIV-1 specific cytotoxic T lymphocyte (CTL) infusion
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.
Time frame: 48 weeks for Cohort 1, 72 weeks for Cohort 2, 96 weeks for Cohort 3
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.
Time frame: 72 weeks for Cohort 1, 96 weeks for Cohort 2, 120 weeks for Cohort 3
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
Late treatment is defined cART should be administered according to local HIV treatment guidelines.
Time frame: 120 weeks
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
This study is status unknown, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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