Clinical and immunologic effects of combination therapy with intravenous immunoglobulins and AZT in HIV-infected patients.
30 patients with HIV infection were enrolled to evaluate the clinical efficacy and toxicity of zidovudine (AZT), 0.5 g/day p.o. (Group A) vs. AZT 0.5 g/day p.o. plus intravenous immunoglobulins (IVIG), 0.4 g/kg of body weight for three consecutive days, followed by one treatment of 0.6 g/kg of body weight every fourth week (Group B), over a period of one year. The study was open and randomized. The treatment groups were compared using the following study variables: 1) type of infections, recurrences and severity; 2) change in CD4+ T and CD8+ T cell count; 3) change in platelet count; 4) change in TNF alpha serum levels; 5) the probability of not developing an opportunistic infection over a period of 12 months. Patients from Group B developed less pathological events in comparison to Group A. No significative differences were evident with regard to values of T cell subsets obtained before and after treatment in each group and between the two groups. On the contrary, in 12 out of 15 patients from Group B there was a significant increase in platelet count. In both groups there was a significant decrease of mean serum levels of TNF alpha when a comparison was made between time 12 vs. time 6. However, when data were expressed as single values, in three subjects from Group B TNF alpha was still detectable by time 12 vs. 9 individuals in Group A. The cumulative probabilities of developing an opportunistic infection over the 12 months of treatment in the Group A subjects were significantly higher than in the Group B subjects (p less than 0.01). Adverse effects--nausea and gastric pain--were reported for 3 individuals (20%) from Group A and 4 patients (26%) from Group B. In conclusion, patients treated with AZT are especially likely to benefit from IVIG prophylaxis.
De Simone
C
C
Insegnamento di Malattie Infettive, Università, L'Aquila.
Tzantzoglou
S
S
Santini
G
G
Vullo
V
V
di Orio
F
F
Leuter
C
C
Jirillo
E
E
Delia
S
S
D000328:Adult; D005260:Female; D015658:HIV Infections / Q000276:immunology / Q000628:therapy*; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000008:administration & dosage* / Q000009:adverse effects; D007958:Leukocyte Count; D008297:Male; D010976:Platelet Count; D014409:Tumor Necrosis Factor-alpha / Q000032:analysis; D015215:Zidovudine / Q000008:administration & dosage* / Q000009:adverse effects
D016756:Immunoglobulins, Intravenous; D014409:Tumor Necrosis Factor-alpha; D015215:Zidovudine