Reducing HIV Persistence in Lymph Nodes by Interleukin-15 (IL-15) Receptor Super-agonist (N-803) in Acute HIV Infection
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- HIV/AIDS
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Masking Description: This study is unblinded.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 40 years
- Gender
- Both males and females
Description
This is a phase II, randomized, unblinded, controlled trial to investigate the safety, tolerability and immunomodulation effect of combining N-803 with antiretroviral therapy (ART) during acute HIV infection (AHI). The study will be conducted at one study site, the Thai Red Cross AIDS Research Centr...
This is a phase II, randomized, unblinded, controlled trial to investigate the safety, tolerability and immunomodulation effect of combining N-803 with antiretroviral therapy (ART) during acute HIV infection (AHI). The study will be conducted at one study site, the Thai Red Cross AIDS Research Centre (TRCARC) in Bangkok, Thailand. Eligible participants will be asked to undergo LN Bx at baseline (untreated AHI), prior to initiating dolutegravir-based ART. N-803 will be administered subcutaneously at weeks 0, 3, 6 (total 3 doses) and will be initiated together with ART. Participants will be asked to undergo a second inguinal LN Bx on the opposite groin approximately at week 6 (no later than 1 week after completion of study agents). They will be followed for safety parameters at weeks 8 and 12, after which they will roll over to the RV412, WRAIR#2178 safety monitoring protocol. The study duration for individual participants will be approximately 12 weeks. The study may include additional optional procedures at baseline and week 6 such as leukapheresis, brain MRI imaging and lumbar puncture, according to participants' consent. It is hypothesized that N-803 initiated with ART during AHI, will be safe, and will lead to a reduction of HIV reservoir size in LN, demonstrated by decreased frequencies of vRNA+ and vDNA+ cells in the LNs, in comparison with ART alone.
Tracking Information
- NCT #
- NCT04505501
- Collaborators
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Walter Reed Army Institute of Research (WRAIR)
- Investigators
- Study Chair: Denise C Hsu, MD PhD Henry M. Jackson Foundation for the Advancement of Military Medicine