In a randomized, controlled double-blind study, 15 patients with AIDS-related complex/Walter-Reed 5 (ARC/WR5) were compared during 6 months intravenous immunoglobulin (IVIG) treatment (0.4g/kg body weight every 2 weeks) with 15 placebo-treated patients. This study was aimed at the lymphocyte response to T and B cell mitogens and antigens. 3H-thymidine uptake was determined after stimulation with the unspecific mitogens phytohemagglutinin (PHA), pokeweed mitogen (PWM), formalinized Staphylococcus aureus-Cowan I (SAC), and with the antigens tuberculin and herpes simplex virus (HSV) at the onset, on days 85, 183, 267 and 351; IgG and IgM antibodies against HSV were measured by ELISA. In addition, 30 untreated HIV-negative controls were tested. For the T cell mitogen PHA, T-cell-dependent B cell mitogen PWM and B cell mitogen SAC, no differences between the two patient groups were observed before therapy nor in the course of therapy or the 6-month observation period thereafter. The entire patient group showed significantly impaired mitogenic response on day 1 as compared to the controls. There was no significant difference in response to tuberculin between the patients and HIV-negative controls, nor for both patients groups before and in the course of treatment. All patients had IgG antibodies against HSV. Three of them showed blastogenie lymphocyte response to HSV on day 1. Among 19 seropositive controls, 7 individuals showed positive HSV lymphocyte response; but for both patient groups, there was no significant difference before and in the course of the treatment and observation period. We concluded that, in spite of some clinical improvement regarding fever and fatigue during IVIG treatment of ARC/WR5 patients, there is no influence on lymphocyte function, as measured by response to mitogens and antigens.
Thirty patients with AIDS-related complex/Walter-Reed 5 enrolled in a placebo-controlled double-blind study with high-dose intravenous gammaglobulin administration were tested by quantitating HIV Western blot and other serological tests for viral antibodies. Furthermore, conventional virus isolation attempts were performed. Absence or loss of p24 antibodies during the study period was associated with progression to AIDS (p = 0.01) and thereby was an earlier prognostic parameter of a poor prognosis than T4 cell count. Neither changes in antibody patterns against other HIV polypeptides, HIV titers in the immunofluorescence test nor demonstration of HIV antigen were significantly associated with progression to AIDS. Cytomegalovirus (CMV) could be isolated from two duodenal biopsies of a patient who developed AIDS at the same time, but a concomitant serological diagnosis of CMV infection was not successful. Though signs in the serology of human herpesviruses (herpes simplex virus, CMV, Epstein-Barr virus), possibly indicating a reactivation of latent infections, could be observed in some instances, a correlation with clinical symptoms or the clinical outcome was not feasible, perhaps also because of a poor standardization of some of the test kits used. All patients were positive for IgG antibodies against the three herpesviruses when entering the study. High prevalence of hepatitis B virus (HBV) markers was found (83% anti-HBc positive), only 1 patient being chronically infected and highly infectious, as shown by HBV-DNA hybridization. No significant difference between treatment and placebo group was observed with the parameters tested in this study.
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