Robert B. Belshe

Pharmacokinetics of a single dose of rimantadine in young adults and children.

Single doses of rimantadine were given to children and young adults to evaluate the safety and pharmacokinetics of this antiviral compound. The half-life of rimantadine in young adults was 27.7 +/- 4.9 h for tablets and 27.8 +/- 8.0 h for syrup preparations. A total of 10 children, 5 to 8 years old, received a syrup preparation of rimantadine. The half-life of rimantadine in children was 24.8 +/- 9.4 h. A single dose of rimantadine was well tolerated in young adults and children.

Pharmacokinetics of rimantadine hydrochloride in patients with chronic liver disease

Six patients with chronic liver disease and six sex‐, age (± 5 years)‐, and weight (± 5 kg)‐matched healthy control subjects received a single dose of two 100 mg tablets rimantadine HCl. Eight additional patients with chronic liver disease who were not matched to healthy subjects received a single dose of two 100 mg tablets of rimantadine HCl. Blood and urine samples were collected and rimantadine concentrations were determined by a GCMS method. The values for maximum plasma concentration, AUC, elimination half‐life, and renal clearance were not significantly different between patients and control subjects, independent of the statistical analyses (parametric and nonparametric) used. The mean apparent elimination half‐life, volume of distribution, and total clearance in the matched patients with liver disease were 32 hours, 24 L/kg, and 676 ml/min, respectively. Renal clearance and the amount excreted in the urine unchanged were 63 ml/min and 10%, respectively. In conclusion, rimantadine pharmacokinetics were not appreciably altered in patients with less severe chronic liver disease.

Characteristics of a population volunteering for human immunodeficiency virus immunization. NIAID AIDS Clinical Trials Network.

A total of 166 volunteers for an AIDS vaccine study (VaxsynR baculovirus produced recombinant GP160; MicroGeneSys Inc, West Haven, Connecticut, USA) were interviewed and examined. Blood was collected for routine laboratory testing as well as T-cell counts, HIV ELISA (EIA), Western blot (WB) and p24 Ag. Eighty-five men (mean age 22.2 years, range 18–42) and 81 women (mean age 23.9 years, range 17–50) volunteered; 130/166 (78%) were university students. Most had learned of the study from news media (55%), friends or workplace (37%). The most common causes for exclusion were the presence of indeterminate WB (26.5%) or a change of mind after the initial interview (24%). Other causes were abnormal cell count and differential (7.2%), elevated alanine aminotransferase (3.6%), positive hepatitis B antibody (3.6%), abnormal urinalysis (3.4%), recent venereal disease (3.0%), T4 cell count <400 (1.9%), abnormal chest X-ray (1.7%), recognized high-risk behaviour (1.7%), multiple sex partners (1.2%), positive rapid plasma reagin test (1.2%), failure to meet age criteria (1.2%), unable to be available for entire study (1.2%), abnormal physical examination (0.6%) and positive p24 Ag (0.6%). No volunteers had positive EIA, but 14.5% had more than one reason for exclusion. Even in a community with low prevalence for HIV, a large majority of healthy heterosexual volunteers can be expected to be ineligible for enrolment in HIV vaccine trials. An average of 4.8 volunteers were screened for each of 12 vaccinees chosen.

Clindamycin therapy of cerebral toxoplasmosis in an AIDS patient.

A 47-year-old patient with AIDS and cerebral toxoplasmosis was treated with sulfadiazine pyrimethamine for 5 days. After developing a severe rash his regimen was changed to clindamycin 600 mg q 6 h intravenously and pyrimethamine 25 mg daily, given for 37 days. This resulted in improvement of clinical symptoms and complete resolution of CT scan abnormalities. Clindamycin combined with pyrimethamine may be a useful alternative therapy for cerebral toxoplasmosis in patients who can not tolerate sulfonamides.A 47-year-old patient with AIDS and cerebral toxoplasmosis was treated with sulfadiazine pyrimethamine for 5 days. After developing a severe rash his regimen was changed to clindamycin 600 mg q 6 h intravenously and pyrimethamine 25 mg daily, given for 37 days. This resulted in improvement of clinical symptoms and complete resolution of CT scan abnormalities. Clindamycin combined with pyrimethamine may be a useful alternative therapy for cerebral toxoplasmosis in patients who can not tolerate sulfonamides.