Table 1.
Characteristic | N=17 | |||
---|---|---|---|---|
Age median (range) | 45 (31,57) | |||
Male | 17 (100%) | |||
Race/Ethnicity | ||||
White, non-Hispanic | 8 (47) | |||
Black | 4 (24) | |||
Hispanic | 3 (18) | |||
Asian/Pacific Islander/Other | 2 (12) | |||
KS Disease Characteristics | ||||
Oral lesions | 1 (6) | |||
≥50 lesions | 16 (88) | |||
Tumor-associated edema | 16 (88) | |||
Prior treatment for KS* | 16 (94) | |||
Cytotoxic Chemotherapy | 14 (82) | |||
Local therapies (topical, radiation, or cryotherapy) | 4 (24) | |||
Imatinib | 4 (24) | |||
Other/experimental therapies | 6 (35) | |||
Baseline KSHV Plasma Log-copies/ml, median (IQR) | 4.8 (2.5, 5.8) | |||
CD4 T-cell Count, median (range) | 489 (133, 1132) | |||
HIV Viral load undetectable | 13 (76) | |||
Current Antiretroviral regimens | N =17 (%) | |||
Nucleoside Analog Backbone | ||||
ABC/d4T | 1 (6) | |||
ABC/3TC/ddI | 1 (6) | |||
TDF/FTC or TDF/3TC | 12 (71) | |||
3TC | 1 (6) | |||
AZT/3TC | 1 (6) | |||
Nucleoside-sparing regimen | 1 (6) | |||
Non-Nucleoside Agents | 6 (35) | |||
EFV | 6 (35) | |||
Protease Inhibitors** | 10 (59) | |||
Other Classes (raltegravir, maraviroc) | 5 (29) | |||
PTC299 Cycles Received | 40mg BID | 80mg BID | 100mg BID | Total |
N=3 | N=3 | N=11 | N=17 | |
median (range) | 7 (6,13) | 3 (2,5) | 4 (1,10) | 5 (1,13) |
Abbreviations: KS, Kaposi sarcoma; HIV, human immunodeficiency virus; KSHV, Kaposi Sarcoma-associated herpes virus; IQR, interquartile range; ABC, abacavir; d4T, stavudine; 3TC, lamivudine; ddI, didanosine; TDF, tenofovir; FTC, emtricitabine; AZT, zidovodine; EFV, efavirenz.
Prior treatments included (# of participants): cytotoxic therapies: liposomal doxorubicin (14), paclitaxel (7), vinblastine (1), etoposide (1), vincristine (1), daunomycin (1); Other/experimental therapies included: valproic acid (2), IM-862 (2), rapamycin (1), flavopiridol (1), Col-3 [incyclinide] (3), interferon-alpha (1), VEGF-antisense (1).
Protease inhibitors included were lopinivir/ritonavir, darunavir/ritonavir, and atazanavir with and without ritonavir.