. 2016 Oct 7;3(4):ofw189. doi: 10.1093/ofid/ofw189

Table 1.

Clinical Trials of Latency Reversing Agents in HIV-1 Infection

No.	Clinical Trials	Agent 1	Agent 2	Dosing 1	Dosing 2	Inclusion Criteria	N	Arms	Design	Follow-up	ATI	HIV outcome	Status	Completion
1	NCT01319383	Vorinostat	ChAdV63.HIVconsv + MVA.HIVconsv	400 mg/d	—	ART > 18 mo, VL < 50 cp/mL for 24 wks, CD4 > 300/µL	30	1 arm, Step I - VOR single dose twice, Step II - VOR for 3 consecutive days/week (8 wks)	Phase I/II single group open label	15 wks	N	CA-RNA	Recruiting	2016
2	NCT02336074 RIVER	Vorinostat	ChAdV63.HIVconsv + MVA.HIVconsv	10 × 400 mg/d × 28 d starting W32	5 × 10¹⁰vp W24 Boost 2 × 10⁸vp W32	PHI (diagnosis < 4 wks) RT naive	52	2 arms: ART only/ART interruption for vaccine-boost and VOR	Phase II multicenter randomized controlled open label	42 wks	N	CA-RNA, CA-DNA, SCA-VL, QVOA	Pre-enrollment	2017
3	VOR VAX	Vorinostat	AGS-004 DC therapy	10 × 400 mg	4 injections×2 cycles	ART > 6 mo, RNA < 50 cp/mL for 2 yrs CD4 > 300/µL	12	1 arm	Phase I single site open label	10 wks	N	QVOA	Recruiting	2020
4	NCT02475915 SEARCH 019	Vorinostat	Hydroxychloroquine + Maraviroc	400 mg/day × 14 d W0, W4, W8	200 mg + 150–600 mg/day × 10 wks	ART > 42 wks (started during PHI) VL < 50 cp/mL for 28 wks CD4 > 450/µL	30	2 arms: ART + VHM/ART only	Phase I/II randomized open label	34 wks	Y	Rebound features, CA-RNA, CA-DNA, 2-LTR	Ongoing	2016
5	NCT02471430 ACTIVATE	Panobinostat	IFN peg alpha2a	5, 10 or 15 mg D0, D2, D4	180 µg SC on D0	ART > 2 yr, VL < 50 cp/mL for 2 yrs CD4 > 400/µL	8	2 arms: Panobinostat + pegIFNα2a/Panobinostat	Phase I/II, randomized open label	8 wks	N	CA-RNA, CA-DNA, QVOA, 2-LTR, VL	Pre-enrollment	2020
6	NCT02513901 CHARTER	Chidamide	—	10 mg × 2/w for 4 wks or 30 mg × 2/w for 4 wks	—	ART > 18 mo, RNA < 50 for >1 yr CD4 > 350/µL	12	2 arms: Chidamide 10 mg/Chidamide 30 mg	Phase I/II single site open label dose-finding	8 wks	N	CA-RNA, CA-DNA, VL	Recruiting	2015
7	NCT02092116 REDUC	Romidepsin	Vacc-4x + rhuGM-CSF	5 mg/m² IV weekly for 3 wks	1.2 mg/0.33 × 10⁶ IU × 6 over 12 wks	ART > 1 yr, RNA < 50 cp/mL for >1 yr CD4 > 500/µL	26	2 arms: RMD safety/RMD + Vacc-4x and ATI	Phase I/II single group open label	10 + 41 wks	Y	Rebound features, CA-RNA, CA-DNA, QVOA, VL, anti-HIV responses	Ongoing	2015
8	NCT01933594	Romidepsin	—	0.5 or 2 or 5 mg/m²	—	ART (EFV, RAL or DTG) VL < 50 cp/mL for >1 yr, SCA-VL > 0.4 cp/mL at screening, CD4 > 300/µL	45	6 arms: RMD or placebo × 3 dosing	Phase I/II, multicenter placebo- controlled randomized double-blind, dose-finding	4 wks	N	CA-RNA, SCA-VL	Recruiting	2016
9	NCT02616874 BCN02-ROMI	Romidepsin	MVA.HIVconsv vaccine	5 mg/m²: W3, W4, W5	10⁸ pfu: W0 + W9	Subjects from ChAd-MVA.HIVconsv_BCN01 study + BCN01-RO extension study, ART with RAL or DTG, VL < 50 cp/mL for 3 yrs, CD4 > 500/µL	24	1 arm	Phase I single group open label	52 wks	Y	Rebound features, CA-RNA, CA-DNA, SCA-VL, VL	Pre-enrollment	2017
10	RV 438	Romidepsin	3BNC117 Ab	5 mg/m²: W0, W1, W12, W13	30 mg/kg: W0, W12, W24, W27	ART > 2 yrs started during PHI VL < 50 cp/mL, CD4 > 400/µL	42	4 arms: RMD + 3BNC117/RMD only/3BNC117 only/no intervention	Phase II randomized open label	78 wks	Y	Control <50 cp/mL, rebound features, reservoir markers	Pre-enrollment
11	NCT02269605 BRYOLAT	Bryostatin	—	10 or 20 µg/m²	—	ART > 2 yrs, VL < LOD, CD4 > 350/µL	12	3 arms: Bryostatin 10 µg/m² or 20 µg/m² or placebo	Phase I randomized placebo-controlled double-blind dose-finding	4 wks	N	CA-RNA, VL, 2-LTR	Completed	2015
12	NCT02531295	Euphorbia kansui	—	Tea: 1 g extract powder in 4 fl oz boiled water, daily	—	ART > 3 yrs, VL < 40 cp/mL for 3 yrs, CD4 > 350/µL	9	3 arms: daily tea for 1, 2 or 3 d	Phase I single group open label	4 wks	N	CA-RNA, VL, T-cell activation	Pre-enrollment	2016
13	ANRS VRI04 DALIA2	rhIL7	HIV-Lipo5 DC therapy	20 µg/kg: W0 W1 W2 or W4 W8 W12 W16	30 × 10⁶ DCs: W4 W8 W12 W16	ART > 12 mo, VL < 50 > 6 mo, CD4 > 500/µL	80	4 arms of 20: DC vaccine/DC + IL7/IL7 before DC/IL7	Phase II multicenter randomized open-label	96 wks	N	CA-DNA in blood and rectal biopsies	Pre-enrollment	2020
14	—	GS-9620	—		—				Phase I
15	NCT02443935 TEACH	MGN1703	—	60 mg × 2/w for 4 wks	—	ART > 1 yr, VL < 50 cp/mL CD4 > 350/µL	16	1 arm	Phase I/II open label 2 centers	12 wks	N	CA-RNA, CA-DNA, VL	Ongoing	2017
16	NCT02071095	Poly-ICLC	—	1.4 mg: D1, D2	—	ART > 48 wks, VL < 50 cp/mL for 48 wks, baseline CA-RNA >10 cp/µg RNA, CD4 > 500/µL	15	2 arms: Poly-ICLC (n = 15)/placebo saline injection (n = 5)	Phase I/II placebo-controlled randomized double blind	48 wks	N	CA-RNA, CA-DNA, VL	Ongoing	2016

Abbreviations: Ab, antibody; ART, antiretroviral therapy; ATI, analytical treatment interruption; CA-DNA, cell-associated HIV-1 DNA; CA-RNA, cell-associated unspliced HIV-1 RNA; DC, dendritic cell; DNA, deoxyribonucleic acid; DTG, dolutegravir; EFV, efavirenz; GM-CSF, granulocyte-macrophage colony-stimulating factor; HIV, human immunodeficiency virus; IFN, interferon; IL, interleukin; IV, intravenous; peg, pegylated; pfu, plaque-forming units; PHI, primary HIV infection; RAL, raltegravir; QVOA, viral outgrowth assay; rh, recombinant human; RMD, romidepsin; RNA, ribonucleic acid; SCA-VL, single-copy assay ultrasensitive viral load; VL, plasma viral load; VOR, vorinostat; vp, viral particle; 2-LTR, 2-long terminal repeat circles.