Table 1.
Baseline clinical characteristics of patients.
| IciS-05 | IciS-11 | |
|---|---|---|
| Hematological Data | ||
| Hematological diagnosis | MDS | AML |
| Donor type/graft source | Cord blood + CD34+-cells third party donor | HLA-matched unrelated donor |
| Donor CCR5 | Homozygous CCR5Δ32 | First donor: homozygous CCR5Δ32, second donor: heterozygous CCR5Δ32/WT |
| Recipient HLA | HLA-A*03:01;24:02; HLA-B*07:02;35:01; HLA-Cw*04:01;07:02; HLA-DRB1*01:01;04:04; HLA-DQB1*03:02;05:01 |
HLA-A*01:01;02:01; HLA-B*07:02;-; HLA-Cw*07:02;-; HLA-DRB1*15:01;-; HLA-DQB1*06:02; - |
| Donor-recipient HLA match | 4/6 cord blood donor (A*03:01; -; B*07:02; 35:02; C*07:02; 04;01; DRB1*01:01; 11:04); 50% haploidentical family member (A*24:02;26:01;B*07:02; 14:01;C*07:02;08:02; DRB1*04:04; 14:54; DQB1*03:02; 05:03) |
10/10; 10/10 |
| Pre-transplant chemotherapy | None | 2 induction cycles with cytarabine and idarubicin |
| Conditioning | ATG, fludarabine with busulvex | ATG, fludarabine, and low-dose TBI before initial transplant; ATG fludarabine and treosulfan before second transplant |
| GvHD prophylaxis | Cyclosporine, prednisone | Cyclosporine, prednisone, and mycophenolic acid mofetil |
| GvHD severity | Acute skin GvHD grade 1 | No GvHD |
| Virological data | ||
| Time from HIV-1 diagnosis to allo-HSCT | 14 years | 22 years |
| Time from start cART to allo-HSCT | 14 years | 19 years |
| Host CCR5 | CCR5WT/WT | CCR5WT/WT |
| Predicted HIV-1 co-receptor tropism | CCR5-tropic virus (FPR 68.0–96.2%) | CCR5-tropic virus (FPR 9.7–77.3%) |
| Phenotypic HIV-1 co-receptor tropism | CCR5-tropic virus | CCR5-tropic virus |
| HIV-1 subtype | HIV-1 subtype B | HIV-1 subtype B |
| cART History | 1998: AZT/3TC, NFV. 2005: TNF, EFV, ATV/r 2006: TNF, LPV/r, NVP 2006: TNF, SQV/r, NVP 2008: AZT/3TC, TNF, SQV/r |
1996: AZT, DDI. 1996: D4T, 3TC, SQV 1997: D4T, 3TC, SQV/r 1999: D4T, 3TC, NVP 2003: TNF, 3TC, NVP |
| cART during allo-HSCT procedure | Day -152: TNF/FTC, DRV/r, RAL Day -34 until +68: TNF/FTC, RAL, MVC, ENF Day -5 until +37: ETR added |
Day -19: TNF, FTC, DTG Day +20 until +107: ABC/3TC, DTG |
| Plasma HIV RNA load at allo-HSCT | 20 copies/ml | <50/TND copies/ml |
| HCV | Anti-HCV negative | Anti-HCV negative |
| HBV | HbsAg negative, anti-HBc positive, anti-Hbs negative | HbsAg negative, anti-HBc positive, anti-Hbs positive |
| CMV status pre-SCT | Positive | Positive |
| Donor CMV status | Positive | Positive |
3TC, lamivudine. ABC, abacavir. Allo-HSCT, allogeneic hematopoietic stem cell transplantation. AML, acute myeloid leukemia. Anti-HBc, antibody against hepatitis B core antigen. Anti-HBs, antibody against hepatitis B surface antigen. ATG, anti-thymocyte globulin. ATV/r, ritonavir boosted atazanavir. AZT, zidovudine. cART, combined antiretroviral therapy. CCR5, C-C chemokine receptor type 5. CCR5Δ32, C-C chemokine receptor type 5 delta 32 mutation. CMV, cytomegalovirus. DDI, didanosine. DRV/r, ritonavir boosted darunavir. DTG, dolutegravir. D4T, stavudine. EBV, Epstein-Barr virus. EBV Vca, EBV viral capsid antigen antibody. EBV EBNA, EBV nuclear antigen antibody. EFV, efavirenz. ENF, enfuvirtide. ETR, etravirine. FTC, emtricitabine. FPR, False Positive Ratio. GvHD, Graft-versus-host disease. HBV, hepatitis B virus. HbsAG, hepatitis B surface antigen. HCV, hepatitis C virus. HLA, human leukocyte antigen. LPV/r, ritonavir boosted lopinavir. MDS, myelodysplastic syndrome. MVC, maraviroc. NFV, nelfivnavir. NVP, nevirapine. RAL, raltegravir. RS, respiratory syncytial virus. RTV or r, ritonavir. SQV/r, ritonavir boosted saquinavir. TBI, total body irradiation. TDF, tenofovir disoproxil fumarate. TND, target not detected. TPHA, Treponema pallidum haemagluttination test. WT, wild type.