Table 2.

Response, HIV Control, CD4 Dynamics, TS Prognosis, and History of Therapy for KS

Response	No. of Patients	Time on HAART* at Baseline for Each Patient (months)	Baseline HIV Viral Load (copies/mL)		CD4 Change (cells/μL)		TS† Poor Prognosis (No. of patients)	Previous Cytotoxic Chemotherapy for KS (No. of Patients)
			Median	Range	Median	Range
HIV well controlled on study‡
CR	3	8, 11, 12	< 50	< 50-145§	198	85–270	3	2‖
PR	2	6, 50	< 50	< 50-< 50	187	21–352	2	2‖
SD	6	3, 3, 21, 26, 45, 90	< 50	< 50-< 50	96	−51–243	4	4
PD	1	6	< 50		149		1	1
HIV not consistently controlled on study¶
SD	3	12, 15, 51	< 50	< 50-180,000	−35	−2–−237	3	3
PD	1	9	180		37		1	0

Abbreviations: CR, complete response; HAART, highly active antiretroviral therapy; KS, Kaposi's sarcoma; PD, progressive disease; PR, partial response; SD, stable disease; TS, staging based on tumor and systemic illness.

^*Months on the specific HAART regimen used at time of the screening visit.

^†Revised AIDS KS prognostic criteria, excludes CD4 as prognostic factor.⁴¹

^‡HIV is considered well controlled if viral load is < 200 copies/mL while on study (median, < 50 copies/mL; range, < 50 to 102 copies/mL).

^§Patient with HIV viral load of 145 copies/mL had been adherent to HAART for 12 months and had an HIV viral load < 50 copies/mL 2 months prior. Low-level HIV viremia at the baseline visit was attributed to use of a different polymerase chain reaction assay.⁴²

^‖Four of five responding patients had been previously treated with cytotoxic chemotherapy. All four patients had received prior liposomal doxorubicin (median cumulative dose, 260 mg/m²; range, 120 to 600 mg/m²). In addition, one patient received prior bleomycin and vincristine, and two patients had prior radiation therapy.

^¶Median HIV viral load when measured at off-study visit was 110,000 copies/mL (range, 16,400 to 182,000 copies/mL).