The Safety and Effectiveness of Hydroxyurea and ddI Used Individually or Together in HIV-Infected Patients
Status:
Completed
Trial end date:
2000-01-01
Target enrollment:
Participant gender:
Summary
To determine the safety and tolerability of hydroxyurea at two doses alone and in combination
with didanosine (ddI). To compare the short term antiviral effect of ddI monotherapy versus
hydroxyurea plus ddI, as measured by plasma RNA levels at 8 weeks of therapy. [AS PER
AMENDMENT 10/1/97: Accrual to arms involving hydroxyurea alone has been closed.] Current
antiviral therapies for HIV-1 are limited by a few choices, and the lack of sustained
clinical benefit from the drugs. The mechanisms that account for the lack of prolonged
inhibition of viral replication by these agents are not fully understood. The activity of RT
inhibitors might be potentiated by inhibiting host cellular enzymes essential for efficient
HIV reverse transcription. Based on this information, comparisons of the antiviral effects of
ddI monotherapy and hydroxyurea plus ddI, with the cellular enzyme ribonucleotide reductase
as a potential target, should be done.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)