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
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.
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