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

NCT02231281 Phase 3 UNKNOWN

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.

Details

Lead sponsor	Yongtao Sun, MD, PhD
Phase	Phase 3
Status	UNKNOWN
Enrolment	65
Start date	2014-08
Completion	2018-12

Conditions

• Acute HIV Infection

Interventions

• cART(TDF/AZT+3TC+LPV/r)
• CTL infusion

Primary outcomes

• Change from baseline in HIV DNA quantification at the interruption of cART — 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 — 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.

Countries

China