A Randomized Study of Activity, Safety, and Tolerance of Oral Ro 24-7429 (Tat Antagonist) in Patients With HIV Infection
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
To study the anti-HIV activity of the various doses of Ro 24-7429 monotherapy based on
virologic and immunologic endpoints. To study the safety and tolerance of Ro 24-7429. To
explore relationships between exposure to Ro 24-7429 and its metabolites and antiviral
activity and drug toxicity. To determine a safe, tolerable, and active dose regimen of Ro
24-7429, and to make preliminary observations of Ro 24-7429 in combination with another
antiretroviral nucleoside.
The HIV genome contains a number of genes that regulate viral replication. Control of the
activity of these genes and their encoded proteins represents a potential target for
development of new antiretroviral drugs. The tat (transactivator of transcription of HIV)
antagonist Ro 24-7429 is the first compound for clinical testing that utilizes this approach
for therapy of HIV infection.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)