Methodological issues in AIDS clinical trials. Discussion. Design of clinical trials--approaches to clinical trials design.
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Acquired Immunodeficiency Syndrome↗
Biomedical subjects
P Lietman
Publications and source records attributed to P Lietman.
Biologic response (antiviral) to recombinant human interferon alpha 2a as a function of dose and route of administration in healthy volunteers.
The kinetics of the antiviral effect of intramuscular and intravenous injections of recombinant human interferon alpha 2a were investigated in healthy volunteers. Cohorts of eight to 11 subjects received single intramuscular injections of either 0.3 X 10(6), 3 X 10(6), or 18 X 10(6) U or an intravenous infusion of 18 X 10(6) U over 30 minutes. Serial samples of peripheral blood mononuclear cells were analyzed for antiviral effects including both (2'-5') oligoadenylate synthetase activity and resistance to vesicular stomatitis virus infection in vitro. A dose-response relationship was established between recombinant human interferon alpha 2a dose and both vesicular stomatitis virus resistance and (2'-5') oligoadenylate synthetase activity. At the 0.3 X 10(6) U dose an antiviral effect occurred without clinical side effects. The presence of clinical side effects is not necessary for an antiviral effect.
2',5'-Oligoadenylate Synthetase↗
A study of potential vestibulotoxic effects of once daily versus thrice daily administration of tobramycin.
Tobramycin 5.1 mg/kg/day was administered for 9 days to 20 healthy human volunteers to determine the potential vestibulotoxicity of once daily versus thrice daily treatment regimens. Vestibular function was tested carefully before, during, and following drug administration, using a battery of postural and caloric tests. Although subjects receiving the once daily regimen performed better on the postural tests, we feel this does not necessarily indicate an adverse effect in either group. The caloric test was the primary measure of vestibular function in this experiment, and this test appeared to demonstrate a slight adverse effect during drug administration of equal magnitude in both treatment groups. The results of this experiment indicate that there is no significant difference in the risk of adverse vestibular effects between once daily and thrice daily tobramycin administration.
Adult↗
Reference values for serial vestibular testing.
This study defines the normal limits of day-to-day variation in vestibular function. A short-acting caloric test was used and nystagmus intensity was measured by means of an interactive computerized technique. Data were analyzed from 30 normal subjects tested on three successive days and from ten of these subjects who were also tested on 11 additional occasions. Individual caloric test scores generally remained between 55% and 170% of their initial value; narrower ranges resulted when scores were averaged together. There was very little habituation of caloric responses. The upper normal limits of test-retest variation in scores for right-left difference and directional preponderance of caloric responses were 24% and 22%, respectively.
Caloric Tests↗