Levy J, Youvan T; International Conference on AIDS.
Int Conf AIDS. 1993 Jun 6-11; 9: 493 (abstract no. PO-B28-2149).
OBJECTIVE: To determine efficacy and safety of PHT in AIDS. METHODS: Fifteen physician co-investigators in association with HemaCare Corporation, have conducted a 12-month double blind controlled dosing study of PHT against placebo in 220 patients with HIV disease. Plasma rich in high-titer antibodies to HIV was sterilized with beta-propiolactone, pooled & sterile filtered. Either 500 cc of plasma (full dose), 250 cc of plasma mixed with 250 cc of 5% albumin (half dose), or 500 cc of 5% albumin (placebo) was infused monthly. RESULTS: The 12-month efficacy analysis showed the following positive treatment effects in the 72 subjects who had T4 cell counts (at study entrance) of 50-200 cells/mm3: full dose treatment improved survival in a dose response trend analysis comparing full dose to half dose to placebo (full = 1 death in 21; half = 3 deaths in 21; placebo = 6 deaths in 30), p = .065. By chi-square analysis: Full dose in contrast to placebo showed improved survival, p = .12. Full dose improved T4 cell levels 32.7 cells/mm3 as compared to a loss of 2.5 cells/mm3 in the placebo group, p = .033. Neither benefit was observed in patients starting study with less than 50 T4 cells/mm3. No serious toxicity was noted in recipients and there were no withdrawals from the study because of adverse reactions. No adverse effects of repeated donations of plasma were observed in donors. CONCLUSION: PHT appears to be a promising new therapy for AIDS patients with greater than 50 T4 cells/mm3. Further expanded studies of PHT appear warranted.
Publication Types:
Keywords:
- Acquired Immunodeficiency Syndrome
- Anti-HIV Agents
- CD4-Positive T-Lymphocytes
- California
- Double-Blind Method
- Drug Therapy, Combination
- HIV
- HIV Antibodies
- HIV Antigens
- HIV Core Protein p24
- HIV Infections
- HIV Seropositivity
- Humans
- Safety
- drug therapy
- immunology
- therapy
Other ID:
UI: 102205144
From Meeting Abstracts