Faculty Bibliography

Fifteen patients with acquired immune deficiency syndrome (AIDS) and opportunistic infection, were randomized to receive treatment with either thymostimulin (TP-1) at 1 mg/kg for 14 days then weekly for 12 weeks or placebo. The objectives of this study were to evaluate the toxicity of TP-1 in this patient population and to make observations on clinical response as measured by time to second opportunistic infection (OI) and changes in laboratory parameters of immune function. The study demonstrates that TP-1 can be administered safely. There were no differences, however, in time to second OI or overall survival between patient groups. In addition, no change in the immune function could be detected in patients receiving thymostimulin

Ganciclovir (DHPG) treatment of 69 AIDS patients with gastrointestinal infection due to cytomegalovirus (CMV) was studied. Sites of infection included the colon (46 patients, 67%), esophagus and stomach (15 patients, 22%), rectum (five patients, 7%), liver (two patients, 3%), and small bowel (one patient, 1.4%). Ganciclovir was given in a dose of 5 mg/kg intravenously every 12 hours for 14 days. Maintenance therapy consisted of 6 mg/kg daily. Positive clinical responses were seen in 52 (75%) of the 69 patients, stable responses in 9 (13%), and worsening in eight (11%). The virologic response was positive in 47 patients (68%), while virologic findings did not change in three patients (4%) and could not be evaluated in 19 patients (28%). Toxicity was mainly hematologic, with moderate leukopenia (1,000-1,900 leukocytes/mm3) in seven patients and severe leukopenia (less than 1,000 leukocytes/mm3) in three patients. The median survival time was 18 weeks (range, 1-68 weeks). Forty-seven patients survived for 4 weeks; of these, 22 (47%) relapsed. The median time to relapse was 9 weeks. Despite the uncontrolled nature of this study, ganciclovir is probably an effective and safe agent for the treatment of gastrointestinal CMV infections. The high probability of relapse (50%) should be considered and maintenance therapy offered to most patients

9-(1,3-dihydroxy-2-propoxymethyl) guanine (ganciclovir) was used to treat 41 patients (median age, 37 years) with the acquired immunodeficiency syndrome and cytomegalovirus gastrointestinal infection. Sites of infection were the colon in 31, the esophagus in 5, the rectum in 4, and the small bowel in 1. Patients received ganciclovir, 5 mg/kg body weight, intravenously every 12 hours for 14 days. Clinical improvement was seen in 30 patients and virologic response in 32. Mainly hematologic toxicity occurred: moderate leukopenia (1000 to 1900/mm3) was seen in 7 patients and severe (less than 1000/mm3) in 1, and moderate neutropenia (500 to 1000/mm3) in 5 and severe (less than 500/mm3) in 1. A cutaneous rash developed in 2 patients. Median overall survival was 16 weeks (range, 2 to 56). Cytomegalovirus recurred in 13 patients; median time to recurrence was 9 weeks from the start of treatment. Ganciclovir may be effective in treating cytomegalovirus gastrointestinal disease in patients with the acquired immunodeficiency syndrome