HIV Infections Clinical Trial
Official title:
A Phase I Safety and Pharmacokinetics Study of BMY-27857 (2',3'-Didehydro-3'-Deoxythymidine) Administered Twice Daily to Patients With AIDS or AIDS Related Complex
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.
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.
A maximum tolerated dose (MTD) has been found in Phase I trials to date. An MED will be
determined. The daily dose of d4T is divided into 2 portions and administered approximately
12 hours apart for 10 weeks. 5 patients receive the initial dose level and successive groups
of 5 patients enter the study at a lower dose level once 3 patients in the preceding group
have successfully completed at least 3 weeks of dosing and shown a positive effect on CD4
cell count and p24 antigen levels. The initial group of patients continue dosing at their
dose level for an additional 94 weeks as long as they are doing well as measured by p24
antigen levels and CD4 cell counts. The dose de-escalation scheme continues until a lack of
efficacy is seen in 2 of 5 patients in any group. Patients are assigned to de-escalating
dose level treatment groups in the order in which they are enrolled. Blood and urine samples
are taken regularly to check for toxic effects and therapeutic effectiveness. In each dosing
group, 3 of 5 patients will be p24 antigen positive greater than or equal to 70 pg/ml, and 2
of 5 patients will have CDC-defined AIDS.
;
Endpoint Classification: Pharmacokinetics Study, Masking: Open Label, Primary Purpose: Treatment
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