We were involved in the study of AIDS since 1981. Currently, 53 children and 47 adults with AIDS are cared for by us. Our previous studies demonstrated in all patients a progressive humoral immunodeficiency. Consequently, 12 adults and 16 children were treated by periodic generic intravenous gammaglobulin. As a result, a dramatic clinical improvement was noted in some patients and episodes of sepsis were completely abolished in most patients. In addition, favorable changes in immunological parameters were noted (see previous work section). The outcome varied, however, from patient to patient and sometimes in the same patient. Recent studies have shown that some i-v GG lots had high antibody titers to HTLV. The present study is designed to determine if i-v GG with anti-HTLV activity can further improve the clinical outcome. Patients will be randomized for four treatment regimen (blinded): a) generic i-v GG, b) i-v GG with high HTLV antibody titer, c) placebo, d) intramuscular hepatitis B hyperimmune serum (shown to have high HTLV antibody levels). We will study the effect of treatment on 1) clinical course, 2) immunological responses (lymphocyte mitogenic responses, T cell phenotypes), 3) presence of HTLV in patients's lymphocytes, 4) serum levels of HTLV antibodies will be determined before and during treatment. Finally, we will attempt to raise a human monoclonal antibody to HTLV (human-human cell hybridization) for possible future treatment protocols.
| Calvelli, T A; Rubinstein, A (1986) Intravenous gamma-globulin in infant acquired immunodeficiency syndrome. Pediatr Infect Dis 5:S207-10 |
| Rubinstein, A; Morecki, R; Silverman, B et al. (1986) Pulmonary disease in children with acquired immune deficiency syndrome and AIDS-related complex. J Pediatr 108:498-503 |
