Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002403
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
Safety and Effectiveness of Zintevir AR177 Given to HIV-Infected Patients
Sponsor:
Aronex Pharmaceuticals
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Phase III Multiple Dose Study to Evaluate the Safety Pharmacokinetic Profile and VirologicImmunologic Activity of Zintevir AR177 in HIV-1 Patients
Status:
COMPLETED
Status Verified Date:
1999-12
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:
The purpose of this study is to see if it is safe and effective to give zintevir AR177 to asymptomatic no symptoms HIV-infected patients
Zintevir belongs to a new class of anti-HIV drugs the integrase inhibitors HIV uses the protein integrase to infect a cell Integrase inhibitors block integrase and may stop replication of HIV
Zintevir belongs to a new class of anti-HIV drugs the integrase inhibitors HIV uses the protein integrase to infect a cell Integrase inhibitors block integrase and may stop replication of HIV
Detailed Description:
Zintevir belongs to a new class of anti-HIV drugs the integrase inhibitors The HIV-1 virus uses the protein integrase to incorporate its genetic material into the infected host cell Integrase inhibitors block integrase and may stop replication of the HIV-1 virus
In this open-label Phase III study 3 groups of HIV-positive patients 12 patients total receive escalating doses of intravenous zintevir for 14 consecutive days
In this open-label Phase III study 3 groups of HIV-positive patients 12 patients total receive escalating doses of intravenous zintevir for 14 consecutive days
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 |
|---|---|---|---|
| AR177-003 | None | None | None |
| UNAP 3 | None | None | None |