Table 1.
Baseline Participant Characteristics and Study Therapy Received
| 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.