Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00040300
Status:
COMPLETED
Last Update Posted:
2005-07-21
First Post:
2002-06-24
Brief Title:
A 14-Day Study of Racivir When Used in Combination in HIV-Infected Males
Sponsor:
Pharmasset
Organization:
Pharmasset
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate Racivir The safety most effective dosage and how the body reacts to Racivir will be studied
Detailed Description:
The study is a 14-day study with a 21-day follow-up period During the 14-days of active study period participants will receive Racivir once daily in combination with efavirenz and stavudine Following the administration of the first and last dose of study medication patients will remain in the clinic overnight During the study there will be medical and medication histories taken physical examinations vital sign measurements EKGs and routine clinical laboratory tests
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None