Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000760
Status:
COMPLETED
Last Update Posted:
2008-08-04
First Post:
1999-11-02
Brief Title:
A Randomized Study of Activity Safety and Tolerance of Oral Ro 24-7429 Tat Antagonist in Patients With HIV Infection
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Study of Activity Safety and Tolerance of Oral Ro 24-7429 Tat Antagonist in Patients With HIV Infection
Status:
COMPLETED
Status Verified Date:
1998-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NV14224A | None | None | None |