HIV Infections Clinical Trial
Official title:
A Randomized Study of Activity, Safety, and Tolerance of Oral Ro 24-7429 (Tat Antagonist) in Patients With HIV Infection
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.
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.
Ninety-six patients (four treatment arms of 24 patients each) are randomized to receive oral
Ro 24-7429 at 1 of 3 doses or nucleoside control (either zidovudine or didanosine). The
study will be blinded only for the arms receiving Ro 24-7429. Treatment continues for 12
weeks. After 12 weeks, patients on the nucleoside control arm receive the highest tolerated
dose of Ro 24-7429 in addition to their nucleoside.
;
Endpoint Classification: Safety Study, Primary Purpose: Treatment
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