HIV Infections Clinical Trial
Official title:
A Phase I Safety Study of BMY-27857 (2',3'-Dideoxy-2',3'-Didehydrothymidine [d4T]) Administered Four Times Daily to AZT-Intolerant Patients With AIDS or AIDS-Related Complex
To determine the safety and maximum tolerated dose (MTD) of
2',3'-dideoxy-2',3'-didehydrothymidine (d4T) administered to patients with AIDS or AIDS
related complex (ARC) who are intolerant of zidovudine (AZT). The study also begins an
assessment of the effectiveness of d4T therapy on HIV replication, on plasma levels of p24
antigen, and clinical or immunologic parameters associated with AIDS.
Of the methods that are being evaluated to treat HIV-infected individuals, AZT has produced
the best results to date. Toxic effects in approximately 50 percent of patients receiving
AZT may limit its usefulness for prolonged treatment. Long-term treatment may be necessary
to prevent progression of early stage HIV infection to AIDS and to prevent secondary
transmission. Other drugs that may be equally or more effective than AZT and useful in the
long- term treatment of HIV infection must be developed and evaluated. Test-tube and animal
studies of d4T show that the drug can inhibit replication (reproduction) of HIV at
concentrations similar to concentrations of AZT that have anti-HIV activity. These studies
also indicate that the drug may stay in the bloodstream longer than AZT. Thus, it may be
possible for the drug to be as effective as AZT when taken less frequently than AZT. It also
may have a less disturbing effect on other body functions (such as thymidine metabolism).
Of the methods that are being evaluated to treat HIV-infected individuals, AZT has produced
the best results to date. Toxic effects in approximately 50 percent of patients receiving
AZT may limit its usefulness for prolonged treatment. Long-term treatment may be necessary
to prevent progression of early stage HIV infection to AIDS and to prevent secondary
transmission. Other drugs that may be equally or more effective than AZT and useful in the
long- term treatment of HIV infection must be developed and evaluated. Test-tube and animal
studies of d4T show that the drug can inhibit replication (reproduction) of HIV at
concentrations similar to concentrations of AZT that have anti-HIV activity. These studies
also indicate that the drug may stay in the bloodstream longer than AZT. Thus, it may be
possible for the drug to be as effective as AZT when taken less frequently than AZT. It also
may have a less disturbing effect on other body functions (such as thymidine metabolism).
Five patients are enrolled at each dose level and receive d4T for 10 weeks at their initial
dose level. Escalation to the next higher dose level, using a different group of five
patients, occurs after three patients in the preceding group have successfully completed at
least 3 weeks of oral dosing.
;
Endpoint Classification: Pharmacokinetics Study, Masking: Open Label, Primary Purpose: Treatment
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