PMID- 28719012 OWN - NLM STAT- MEDLINE DCOM- 20180529 LR - 20220216 IS - 1468-1293 (Electronic) IS - 1464-2662 (Linking) VI - 18 IP - 10 DP - 2017 Nov TI - The impact of immunoglobulin in acute HIV infection on the HIV reservoir: a randomized controlled trial. PG - 777-781 LID - 10.1111/hiv.12524 [doi] AB - OBJECTIVES: Antiretroviral therapy (ART) during acute HIV infection (AHI) restricts the HIV reservoir, but additional interventions are necessary to induce a cure. Intravenous immunoglobulin (IVIG) is not HIV-specific but is safe and temporarily reduces the HIV reservoir in chronic HIV infection. We present a randomized controlled trial to investigate whether IVIG plus ART in AHI reduces the HIV reservoir and immune activation compared with ART alone. METHODS: Ten men with AHI (Fiebig II-IV) initiated ART (tenofovir, entricitabine, ritonavir boosted darunavir and raltegravir) at HIV-1 diagnosis and were randomized to ART alone or ART plus 5 days of IVIG, once virally suppressed (week 19). Blood samples were evaluated for viral reservoir, immune activation, immune exhaustion and microbial translocation. Flexible sigmoidoscopy was performed at weeks 19, 24 and 48, and gut proviral DNA and cell numbers determined. RESULTS: IVIG was well tolerated and no viral blips (> 50 HIV-1 RNA copies/mL) occurred during IVIG therapy. From baseline to week 48, total HIV DNA in peripheral blood mononuclear cells (PBMCs) (cases: -3.7 log(10) copies/10(6) CD4 cells; controls: -3.87 log(10) copies/10(6) CD4 cells) declined with no differences observed between the groups (P = 0.49). Declines were observed in both groups from week 19 to week 48 in total HIV DNA in PBMCs (P = 0.38), serum low copy RNA (P = 0.57) and gut total HIV DNA (P = 0.55), but again there were no significant differences between arms. Biomarkers of immune activation, immune exhaustion and microbial translocation and the CD4:CD8 ratio were similar between arms for all comparisons. CONCLUSIONS: Although safe, IVIG in AHI did not impact total HIV DNA, immune function or microbial translocation in peripheral blood or gut tissue. CI - (c) 2017 British HIV Association. FAU - Tiraboschi, J AU - Tiraboschi J AD - Guys and St Thomas' NHS Foundation Trust, London, UK. FAU - Ray, S AU - Ray S AD - Guys and St Thomas' NHS Foundation Trust, London, UK. FAU - Patel, K AU - Patel K AD - Guys and St Thomas' NHS Foundation Trust, London, UK. FAU - Teague, A AU - Teague A AD - Guys and St Thomas' NHS Foundation Trust, London, UK. FAU - Pace, M AU - Pace M AD - University of Oxford, Oxford, UK. FAU - Phalora, P AU - Phalora P AD - University of Oxford, Oxford, UK. FAU - Robinson, N AU - Robinson N AD - University of Oxford, Oxford, UK. FAU - Hopkins, E AU - Hopkins E AD - University of Oxford, Oxford, UK. FAU - Meyerowitz, J AU - Meyerowitz J AD - University of Oxford, Oxford, UK. FAU - Wang, Y AU - Wang Y AD - Division of Health and Social Care Research, King's College London, London, UK. FAU - Cason, J AU - Cason J AD - Department of Infectious Diseases, Kings College London, London, UK. FAU - Kaye, S AU - Kaye S AD - Oxford National Institute of Health, Oxford, UK. FAU - Sanderson, J AU - Sanderson J AD - Guys and St Thomas' NHS Foundation Trust, London, UK. FAU - Klenerman, P AU - Klenerman P AD - University of Oxford, Oxford, UK. FAU - Fidler, S AU - Fidler S AD - Imperial College London, London, UK. FAU - Frater, J AU - Frater J AD - University of Oxford, Oxford, UK. AD - Oxford National Institute of Health Research Biomedical Research Centre, Oxford, UK. FAU - Fox, J AU - Fox J AD - Guys and St Thomas' NHS Foundation Trust, London, UK. LA - eng GR - 109965/Z/15/Z/WT_/Wellcome Trust/United Kingdom GR - MR/L006588/1/MRC_/Medical Research Council/United Kingdom GR - MR/P011233/1/MRC_/Medical Research Council/United Kingdom PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20170718 PL - England TA - HIV Med JT - HIV medicine JID - 100897392 RN - 0 (Anti-Retroviral Agents) RN - 0 (DNA, Viral) RN - 0 (Immunoglobulins, Intravenous) SB - IM MH - Adult MH - Anti-Retroviral Agents/therapeutic use MH - Bacterial Translocation MH - DNA, Viral/blood MH - Drug Therapy, Combination/methods MH - HIV Infections/*drug therapy MH - HIV-1/*isolation & purification MH - Humans MH - Immunoglobulins, Intravenous/*therapeutic use MH - Male MH - Prospective Studies MH - Treatment Outcome MH - Viral Load OTO - NOTNLM OT - HIV reservoir OT - acute HIV infection OT - immunoglobulin EDAT- 2017/07/19 06:00 MHDA- 2018/05/31 06:00 CRDT- 2017/07/19 06:00 PHST- 2017/04/12 00:00 [accepted] PHST- 2017/07/19 06:00 [pubmed] PHST- 2018/05/31 06:00 [medline] PHST- 2017/07/19 06:00 [entrez] AID - 10.1111/hiv.12524 [doi] PST - ppublish SO - HIV Med. 2017 Nov;18(10):777-781. doi: 10.1111/hiv.12524. Epub 2017 Jul 18.