TABLE 2.

Anti-HIV activity of STAMP against BR/92/019 in Hu-PBL-SCID mice^a

Treatment	No. of specimens positive for HIV by NASBA/no. tested (no. Cx positive/no. tested)		Mean viral load ± SE (range) in:		No. with toxic lesions/no. tested
	Spleen	PL	Spleen	PL
i.p. route
Control (vehicle) (n = 16)	15/16 (16/16)	14/14	4.5 ± 0.2 (3.2-5.5)	4.6 ± 0.2 (3.3-5.9)	0/10
STAMP dose (mg/kg)
10 (n = 10)	4/5 (4/5)	2/10	3.9 ± 0.3 (3.1-4.3)	3.8 ± 0.3 (2.9-4.3)	0/5
25 (n = 5)	2/5 (2/5)	2/5	3.8 ± 0.6 (3.2-4.4)	3.5 ± 0.7 (2.8-4.2)	0/5
50 (n = 15)	6/15 (4/15)	1/15	4.2 ± 0.1 (4.0-4.7)	4.1	0/15
100 (n = 9)	2/8 (0/7)	0/9	3.5 ± 0.3 (3.3-3.8)	NAb	0/9
Gavage
Control (vehicle) (n = 23)	20/22	23/23	4.4 ± 0.1 (3.3-5.6)	5.9 ± 0.2 (4.2-7.2)	0/16
STAMP dose (mg/kg)
50 (n = 10)	4/10	7/10	4.4 ± 0.3 (3.8-5.3)	5.0 ± 0.3 (3.8-5.7)	NDc
100 (n = 20)	7/20	12/20	4.0 ± 0.3 (3.1-5.1)	4.8 ± 0.3 (3.1-6.2)	0/10
200 (n = 20)	7/20	12/20	3.7 ± 0.2 (3.2-4.5)	4.8 ± 0.2 (3.2-5.9)	0/9
400 (n = 9)	0/9	1/9	NA	4.8	0/9
Combivir (n = 10)d	3/10	6/10	3.2 ± 0.3 (1.5-3.4)	4.0 ± 0.4 (3.0-5.2)	ND
Added to food
Control (vehicle) (n = 20)	15/20	17/20	4.4 ± 0.2 (3.0-6.4)	4.3 ± 0.2 (2.9-5.5)	0/10
STAMP dose (mg/kg)
200 (n = 10)	3/10	5/8	3.8 ± 0.5 (3.2-4.8)	4.3 ± 0.3 (3.4-5.1)	0/10
400 (n = 10)	1/10	1/9	3.0	3.1	0/10

^aDrugs were administered i.p. or via gavage twice daily for 7 days/week for 2 weeks. All mice were reconstituted with 10⁷ PBMC and infected with 10⁵ 50% tissue culture infective dose of the HIV-1 isolate BR/92/019 2 weeks after reconstitution. Treatments were started immediately after the inoculation of the HIV-1 isolate. Results are presented as the fractions of HIV-NASBA positive and HIV coculture-positive mice as well as the arithmetic mean values of the log₁₀-transformed spleen and peritoneal lavage (PL) viral loads with (ranges are indicated in parentheses). The median values and geometric means for the log₁₀-transformed spleen (peritoneal lavage) viral loads in i.p.-treated mice were, respectively, 4.5 and 4.4 (4.6 and 4.5) for vehicle controls, 4.1 and 3.9 (4.1 and 3.8) for 10-mg/kg STAMP, 3.8 and 3.8 (3.5 and 3.4) for 25-mg/kg STAMP, 4.0 and 4.0 for 50-mg/kg STAMP, and 3.6 and 3.5 for 100-mg/kg STAMP. The median values and geometric means for the log₁₀-transformed spleen (peritoneal lavage) viral loads in gavage-treated mice were, respectively, 4.5 and 4.4 (6.0 and 5.9) for vehicle controls, 4.4 and 4.4 (5.3 and 5.0) for 50-mg/kg STAMP, 3.9 and 3.9 (5.0 and 4.7) for 100-mg/kg STAMP, and 3.7 and 3.7 (4.9 and 4.8) for 200-mg/kg STAMP. The median values and geometric means for the log₁₀ transformed spleen (peritoneal lavage) viral loads in p.o. (food supplement)-treated mice were, respectively, 4.0 and 4.3 (4.5 and 4.3) for vehicle controls and 3.5 and 3.8 (4.6 and 4.3) for 200-mg/kg STAMP.

^bNA, not applicable.

^cND, not determined.

^dCombivir is 400-mg/kg ZDV plus 200-mg/kg 3TC.