HIV Infections Clinical Trial
Official title:
A Phase I Safety and Pharmacokinetics Study of 2',3'-Dideoxyinosine (ddI) Administered Twice Daily to Infants and Children With AIDS or Symptomatic HIV Infection
To determine the safety and maximum tolerated dose (MTD) of 2',3'-dideoxyinosine (ddI),
given orally and intravenously, in infants and children with AIDS. The study also measures
bloodstream and cerebrospinal fluid (CSF) levels of the administered drug, and provides a
preliminary assessment of the effectiveness of ddI on HIV replication.
AMENDED: Based on safety established in the first dosing phase of 52 weeks and long term
dosing data in adults, the dosing period will be extended to 104 weeks. Original design:
Information presently available indicates that ddI has high antiviral activity with less
apparent toxicity than zidovudine (AZT) (the drug presently used to treat AIDS).
AMENDED: Based on safety established in the first dosing phase of 52 weeks and long term
dosing data in adults, the dosing period will be extended to 104 weeks. Original design:
Information presently available indicates that ddI has high antiviral activity with less
apparent toxicity than zidovudine (AZT) (the drug presently used to treat AIDS).
AMENDED: Dosing will proceed for 104 weeks at each dose level. Original design: Five
patients are treated at the initial dose level. Because ddI is not stable in the acid
environment of the stomach, oral doses of ddI follow administration of an antacid. An
alternative method of dosing is to mix the reconstituted ddI with an appropriate volume of
Maalox TC or Mylanta II. In order to determine the MTD, successive groups of 5 patients
enter the study at a higher dose level after 3 patients have experienced 3 weeks of dosing
and significant toxicities have not developed. Patients are assigned to treatment groups in
the order in which they are enrolled. Dosing proceeds for 16 weeks at each dose level.
However, consideration is given to escalating patients entered at the lowest dose to the
next dose level after 10 weeks of dosing. The dose escalation continues until toxicities
requiring dose modifications are found in 2 of 5 in any group.
;
Endpoint Classification: Pharmacokinetics Study, Masking: Open Label, Primary Purpose: Treatment
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