Phase I Pharmacokinetic and Tolerance Study of Ribavirin in Human Immunodeficiency Virus (HIV) - Infected Patients
Status:
Completed
Trial end date:
1991-10-01
Target enrollment:
Participant gender:
Summary
To determine how fast ribavirin reaches the bloodstream, what concentration of ribavirin is
reached in blood and how long it remains in the blood (pharmacokinetics) when given by
different routes of administration. To find the maximum tolerated dose (MTD) of ribavirin.
The effects of ribavirin on the immune system, and on the virus will be measured by T4 cell
count and p24 antigen levels.
Early studies with ribavirin in patients with AIDS and AIDS related complex (ARC) have shown
that ribavirin appears to inhibit the spread of the virus. Determination of how much and how
often to give the drug will require further knowledge of the pharmacokinetics and toxicity of
the drug in patients with AIDS or ARC and in chronic virus carriers who do not have symptoms.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)