Clinical Trials Logo
  1. Home
  2. Acute HIV Infection
  3. NCT02231281

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

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

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02231281
Study type Interventional
Source Tang-Du Hospital
Contact
Status Active, not recruiting
Phase Phase 3
Start date August 2014
Completion date December 2018
View Details
See also
  Status Clinical Trial Phase
Completed NCT02384395 - Safety and Efficacy of Fixed Dose Combination Dolutegravir/Abacavir/Lamivudine FDC Initiated During Acute HIV Infection N/A
Completed NCT00734344 - Pilot Study of Raltegravir/Truvada Versus Efavirenz/Truvada for Adults With Acute IV-1 Infection N/A
Completed NCT01434706 - Implementation of Nucleic Acid Amplification Testing Screening to Identify Acute and Early HIV Infection N/A
Active, not recruiting NCT03711253 - Empiric Treatment for Acute HIV in the ED Phase 4
Completed NCT01154673 - Intense Acute Infection Study Phase 2/Phase 3
Terminated NCT00855413 - HIV Viremia and Persistence in Acutely HIV-Infected Patients Treated With Darunavir/Ritonavir and Etravirine Phase 4
Completed NCT02467439 - Acute Partner and Social Contact Referral: iKnow N/A
Not yet recruiting NCT05719441 - A Clinical Trial of Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined With ART Initiation During Acute HIV Infection to Induce HIV Remission Phase 2
Completed NCT03579381 - Specimen Repository for HIV Immunopathogenesis
Completed NCT01369056 - HAART Adherence Among HIV-infected Persons and the Factors Affecting Treatment Adherence N/A
Completed NCT02170246 - Analysis of Telmisartan Administered With Antiretroviral Therapy (ART) in Patients With Acute HIV Infection Phase 1
Completed NCT02470351 - Assessment of the HIV CNS Reservoir, Neurological and Neuro-cognitive Effects, and Source of Rebound HIV in CNS N/A
Completed NCT02750059 - Using Telmisartan With ART During Acute HIV Infection to Reduce the CNS Reservoirs of HIV and Lymph Node Fibrosis Phase 2
Completed NCT02475915 - Efficacy of VHM After Treatment Interruption in Subjects Initiating ART During Acute HIV Infection Phase 1/Phase 2
Completed NCT00924898 - Treatment of Acute HIV With Emtricitabine, Tenofovir and Efavirenz (CID 0805) Phase 4
Completed NCT02614950 - Viral Suppression After Analytic Treatment Interruption in Thai Patients Who Initiated Highly Active Antiretroviral Therapy During Acute HIV Infection N/A
Completed NCT01197027 - Feasibility and Acceptability Study of an Individual-Level Behavioral Intervention for Individuals With Acute and Early HIV-Infection Phase 3
Recruiting NCT05728996 - Netherlands Cohort Study on Acute HIV Infection
Recruiting NCT00796146 - Establish and Characterize an Acute HIV Infection Cohort in a High Risk Population
Recruiting NCT00796263 - Antiretroviral Therapy for Acute and Chronic HIV Infection Phase 3