Table 2.
Immune-Based Therapies and Immunomodulation Trials
| No. | Clinical Trials | Agent 1 | Agent 2 | Dosing 1 | Dosing 2 | Inclusion Criteria | N | Arms | Design | Follow-up | HIV Outcome | Status | Completion |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 |
NCT02595866 CITN-12 |
Pembrolizumab | — | 200 mg every 21 d | — | Advanced malignancy, ART > 4 wks, VL < 200 cp/mL CD4 > 100/µL |
36 | 1 arm | Phase I single group open label | 104 wks | CA-RNA, SCA-VL, TILDA, integrated HIV-1 DNA | Pre-enrollment | 2018 |
| 2 |
NCT02408861 AMC095 |
Nivolumab | Ipilimumab | 3 mg/kg D1, D15, D29, D43 or D1, D22, D43, D64 Maintenance every 14 d | 1 mg/kg D1, D22, D43, D64: with nivolumab | Advanced solid tumor malignancy, VL < 75 cp/mL with or w/o cART, CD4 > 200/µL | 42 | 2 arms nivolumab 2 arms nivolumab + ipilimumab | Phase I single group open label, dose-finding | 156 wks | VL, QVOA | Recruiting | 2020 |
| 3 | NCT02028403 | BMS-936559 | — | Single dose: 0.3 mg/kg; 1 mg/kg; 3 mg/kg; 10 mg/kg |
— | ART, VL below limit for 2 yrs, SCA > 0.4cp/mL in last 3 mo, CD4 > 350/µL | 56 | 4 arms: 4 doses | Phase I multicenter randomized double-blind placebo-controlled, dose-escalation | 48 wks | CA-RNA, CA-DNA, 2-LTR, SCA-VL, anti-gag CD8 responses | Completed | 2015 |
| 4 | NCT02191098 | ALT-803 | — | Weekly injection | — | ART > 3 yrs, VL < 50 cp/mL for 2 yrs, CD4 > 500/µL | 10 | 1 arm | Phase I open label single arm, dose-escalation | 4 wks | TILDA | Pre-enrollment | 2016 |
| 5 | NCT01935089 | peg-IFNα2b | — | 1 µg/kg per wk for 20 wks | — | ART < 1 yr, VL < 50 cp/mL for 1 yr, CD4 > 450/µL | 25 | 1 arm | Phase II single group open label | 24 wks | CA-DNA | Ongoing | 2016 |
| 6 | NCT01295515 | peg-IFNα2b | — | Weekly injection (HCV dose) for 4 wks | — | ART, VL < 50 cp/mL for 1 y, CA-RNA >5 cp/106 PBMC, CD4 > 300/µL | 65 | 1 arm | Phase I/II single group open label | 52 wks | VL, CA-RNA | Recruiting | 2020 |
| 7 | NCT02475655 | Ruxolitinib | — | 10 mg × 2/d for 5 wks |
— | ART > 2y, VL < 50 > 1 yr CD4 > 350 |
60 | 2 arms: ART + ruxolitinib/ART only | Phase II multicenter randomized open label | 12 wks | SCA-VL, CA-RNA, CA-DNA, integrated HIV-1 DNA, 2-LTR | Pre-enrollment | 2016 |
| 8 | NCT02440789 | Sirolimus | — | 0.025 or 0.05 mg/kg per day for 20 wks |
— | ART > 2 yrs, VL below limit for 2 yrs, CD4 > 400/µL | 30 | 2 arms: 2 doses depending on ART regimen | Phase I/II multicenter single group open label | 44 wks | CA-RNA, CA-DNA, SCA-VL, anti-gag CD8 responses, VL | Recruiting | 2017 |
| 9 | NCT02429869 | Everolimus | — | Target trough level 3–8 ng/mL for 6 mo | — | Liver/kidney transplant, ART, VL < 50 cp/mL for 2 yrs, CD4 > 350/µL | 10 | 1 arm | Phase IV single group open label | 52 wks | CA-DNA | Pre-enrollment | 2017 |
Abbreviations: ART, antiretroviral therapy; CA-DNA, cell-associated HIV-1 DNA; CA-RNA, cell-associated unspliced HIV-1 RNA; DNA, deoxyribonucleic acid; HIV, human immunodeficiency virus; IFN, interferon; PBMC, peripheral blood mononuclear cells; peg, pegylated; QVOA, viral outgrowth assay; RNA, ribonucleic acid; SCA-VL, single-copy assay ultrasensitive viral load; TILDA, Tat/Rev-induced limiting dilution assay; VL, plasma viral load; 2-LTR, 2-long terminal repeat circles.