Biotherapy 9: 41-7 (1996)
H. Hugh Fudenberg,1 Giancarlo Pizza,2 F. Raise,3 F. Gritti,3 F. Chiodo,2 C. DeVinci,2 Dimitri Viza.4
- NeuroImmuno Therapeutics Research Found., Spartanburg SC 29303;
- Osp. Malpighi, 40138 Bologna, Italy;
- Osp. Maggiore, Bologna, Italy;
- Université de Paris V, Faculté de Médecine, 75270 Paris, France.
Rationale: Specific transfer factor (TF) is known to be effective in treating viral infections and preliminary studies with AIDS patients and SIV-infected macaques have produced encouraging observations.
Methods: TF was made from immunized BALB/c mice. Its activity was tested in vitro, and it was orally administered to AIDS patients with <500 CD4 lymphocytes.
Results: 20 AIDS patients, treated with TF and zidovudine (ZDV) for more than 6 months, showed improvement or stabilization of their clinical condition and/or biological parameters. Four patients with a survival prognosis of 6 months have so far survived for more than 4 years. In one patient, a regression of KS and voluminous plantar warts was noticed. Skin tests became positive in 9/12 anergic patients. Furthermore, data in 5 patients suggest that TF may activate the Th/1 cytokine secretion pattern. Three other patients had PCR's that dropped from 268,000/mm3 to 24,000/mm3; 100,000/mm3 to 2,000/mm3; and 80,000/mm3 to 0.
Conclusion: HIV specific TF can be beneficial even in advanced AIDS patients. Further studies should determine whether treatment could indefinitely arrest disease progression. TF may also be able to prevent retroviral infections; and as a prophylactic vaccine (as in the case of VZV infections in immunocompromised leukemic children), it should be further investigated in animal models.