A Multi-Center, Open-Label, Ascending, Multiple Oral Dose, Safety, Tolerance and Pharmacokinetic Study of 3'-Deoxy-3'-Fluorothymidine (FLT) in Patients With Acquired Immune Deficiency Syndrome (AIDS) or AIDS-Related Complex (ARC)
Completed
Lederle Laboratories
N/A
To assess the tolerance and toxicity profile of deoxy-3'-fluorothymidine (FLT) after multiple
oral dosing for 16 weeks. To characterize the steady-state pharmacokinetics of FLT after
multiple oral doses. To assess the effect of FLT on immunologic and virologic markers of HIV
infection (CD4+ lymphocyte count, p24 antigen, viremia) in patients with AIDS or AIDS related
complex (ARC) after multiple oral dosing for 16 weeks.
An Open-Label, Crossover Study to Assess the Effect of Food on the Oral Bioavailability and Pharmacokinetic Profile of 3'-Deoxy-3'-Fluorothymidine (FLT) in Asymptomatic Human Immunodeficiency Virus (HIV)-Infected Subjects
Completed
Lederle Laboratories
N/A
To characterize the pharmacokinetics of orally administered FLT (in a liquid formulation)
after single doses in both the fed and fasting states; to assess the effect of food on the
oral bioavailability of FLT
An Ascending, Single Oral Dose Pharmacokinetic Study of 3'-Deoxy-3'-Fluorothymidine (FLT) in Asymptomatic Human Immunodeficiency Virus (HIV)-Infected Subjects
Completed
Lederle Laboratories
N/A
To characterize the pharmacokinetics of orally administered 3'-deoxy-3'-fluorothymidine
(FLT), in a liquid formulation, after single doses in asymptomatic HIV-infected patients and
to assess the safety and tolerance of the single oral doses of FLT.
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