A Study of BMY-27857 in Patients With AIDS or AIDS Related Complex
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
To evaluate the safety, minimum effective dose (MED), pharmacokinetics and efficacy of orally
administered 2',3'-dideoxy-2',3'-didehydrothymidine (d4T) in patients with AIDS or AIDS
related complex (ARC). To establish an appropriate dosage regimen of d4T to be employed in
Phase II and III trials. To evaluate the effects of de-escalating doses of d4T on markers
associated with HIV infection.
Currently, the only FDA-approved therapy for patients with AIDS or ARC is zidovudine (AZT), a
drug with significant value but limited use because of toxic effects on the bone marrow. d4T
has not been tested in humans, but it has inhibited the reproduction of HIV (the virus that
causes AIDS) in laboratory experiments. In some studies with laboratory animals, d4T was less
toxic against blood cells than AZT.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)