TABLE 1.
Anti-HIV-1 activity of TXU (anti-CD7)-PAP in Hu-PBL-SCID micea
| Treatment (dose [μg]) | Total no. of SCID Mice | No. of Hu-PBL-SCID mice with following HIV status by PCR and culture/total no. of Hu-PBL-SCID mice:
|
||||||
|---|---|---|---|---|---|---|---|---|
| PCR+ | Cx+ | PCR+ Cx+ | PCR+ Cx− | PCR+ CxND | PCR− Cx− | PCRND Cx+ | ||
| PBS | 23 | 16/16 | 16/17 | 10/11 | 1/11 | 6/6 | 0/11 | 6/6 |
| TXU (anti-CD7)-PAP | ||||||||
| 10 | 10 | 0/10 | ND | ND | ND | 0/10 | ND | ND |
| 20 | 10 | 0/10 | ND | ND | ND | 0/10 | ND | ND |
| B53 (anti-CD4)-PAP | ||||||||
| 10 | 5 | 5/5 | ND | ND | ND | 5/5 | ND | ND |
| 20 | 4 | 3/4 | 0/3 | 0/3 | 3/3 | 1/1 | 0/3 | ND |
| 40 | 18 | 3/18 | 0/11 | 0/11 | 2/11 | 1/7 | 9/11 | ND |
| 60 | 5 | 0/3 | 0/5 | 0/3 | 0/3 | ND | 3/3 | 0/2 |
| B43 (anti-CD19)-PAP, 20 | 5 | 5/5 | ND | ND | ND | 5/5 | ND | ND |
| AZT | 10 | 4/10 | 4/8 | 4/8 | 4/8 | 0/2 | 0/8 | ND |
| Control Hu-PBL-SCID mice (no HIV infection, no treatment) | 17 | 0/9 | 0/16 | 0/8 | 0/8 | 0/1 | 8/8 | 0/8 |
| Control SCID mice (No Hu-PBL, HIV infection, no treatment) | 3 | 0/3 | ND | ND | ND | 0/3 | ND | ND |
Hu-PBL-SCID mice were inoculated with clinical HIV-1 isolates in a biosafety level 3 containment facility. TXU-PAP immunoconjugate was administered intraperitoneally by injecting half of the total dose as an intraperitoneal bolus dose and delivering the remainder of the total dose over 2 weeks by using Alzet micro-osmotic pumps (regimen A) (n = 5) or by administering the total dose by daily intraperitoneal injections over a 5-day treatment period (regimen B) (n = 5). B53-PAP was administered by daily intraperitoneal injection over a 5-day treatment period when it was used at a dose of 10 or 20 μg. Mice receiving 40 or 60 μg of B53-PAP received 20 μg of the dose as an intraperitoneal bolus injection and the remainder over 2 weeks by using the Alzet micro-osmotic pumps. Two weeks after infection with HIV-1, Hu-PBL-SCID mice were electively killed and their peritoneal lavage cells as well as spleen cells were examined for evidence of infection by a culture assay for HIV-1 as well as by PCR amplification of a 115-bp DNA sequence in the gag region of the HIV-1 genome. In PBS-treated control Hu-PBL-SCID mice, culture assays for HIV were performed with spleen cells (n = 4) and with a mixture of peritoneal lavage and spleen cells (n = 12). PCR assays for HIV were performed with both spleen cells and peritoneal lavage cells except for two PBS-treated Hu-PBL-SCID mice, whose spleens were not examined by PCR. PCR+, PCR positive; Cx+, culture positive; PCR−, PCR negative; Cx−, culture negative; PCRND, PCR result was not determined; CxND, culture result was not determined; ND, not determined.