Table 1.
Study | Inclusion criteria | Number of participants | Dose and duration of investigational agent | Duration of ATI | Key findings | Ref. |
---|---|---|---|---|---|---|
RV 411 | Fiebig I, on ART for ≥ 96 weeks, HIV RNA < 50 copies/mL for ≥ 48 weeks, integrated HIV DNA in PBMCs of < 10 copies/106 PBMCs, and CD4 T cell of ≥ 400 cells/mm3 | 8 | N/A (study of early ART only) | Up to 24 weeks | Viral rebound was observed in all participants and at a median time of 26 days. ART started in Fiebig I stage did not prevent or delay viral rebound | [59] |
RV 397 | Fiebig I–III, on ART for ≥ 96 weeks, HIV RNA < 50 copies/mL for ≥ 48 weeks, integrated HIV DNA in PBMCs of < 10 copies/106 PBMCs, and CD4 T cell of ≥ 400 cells/mm3 | 18 | VRC01 40 mg/kg IV every 3 weeks for up to 24 weeks | Up to 48 weeks | VRC01 was generally safe and was associated with a trend toward delayed viral rebound: the placebo group experienced viral rebound at a median of 14 days, whereas participants in the VRC01 group at a median of 26 days | [60] |
RV 409 | Fiebig III–IV, on ART for ≥ 42 weeks, HIV RNA < 50 copies/mL for ≥ 28 weeks, CD4 T cell of ≥ 450 cells/mm3 | 15 | Vorinostat PO 400 mg/day 14 days on/off (3 cycles), hydroxychloroquine PO 200 mg BID, maraviroc PO 600 mg BID for 10 weeks | Up to 24 weeks | VHM was well tolerated in the majority of participants. No changes in total HIV DNA in PBMCs were described. All Fiebig III/IV treated participants had viral rebound after ATI; median time to viral rebound was 22 days | [61] |
RV 405 | Fiebig I–IV, on ART for ≥ 4 weeks, HIV RNA < 50 copies/mL for ≥ 48 weeks, CD4 T cell of ≥ 400 cells/mm3 | 26 | Ad26 vaccine 5 * 1010 viral particle per 0.5 mL IM at week 0 and 12, MVA vaccine 108 plaque-forming unit per 0.5 mL IM at week 24 and 48 | Up to 36 weeks | Ad26/MVA was well-tolerated and it contributed to a modest delay in time to viral rebound after analytic treatment interruption | [62] |
pts. participants, ref. reference, ART antiretroviral therapy, PBMCs peripheral blood mononuclear cells, IV intravenous, PO per os, Ad26 adenovirus type 26 vector prime, IM intramuscular, MVA modified vaccinia Ankara