Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002415
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
Safety and Effectiveness of Adding PMPA Prodrug to an Anti-HIV Drug Combination to Treat HIV-Infected Patients
Sponsor:
Gilead Sciences
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Phase II Randomized Double-Blind Placebo-Controlled Study of the Safety and Antiviral Activity of the Addition of PMPA Prodrug to Combination Antiretroviral Regimens in Treatment-Experienced HIV-Infected Patients
Status:
COMPLETED
Status Verified Date:
1999-11
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:
The purpose of this study is to see if it is safe and effective to add PMPA Prodrug a new anti-HIV drug to an anti-HIV drug combination taken by patients who have taken anti-HIV drugs in the past Genetic response will be studied
Detailed Description:
Prior to study entry patients are stratified according to HIV-1 RNA level CD4 cell count and number of antiretroviral drugs PMPA Prodrug or placebo is added to current antiretroviral regimens and is administered in one of three dosing regimens Patients randomized to receive placebo are eligible to receive open-label PMPA Prodrug for the remainder of the 48-week study period after at least 24 weeks post randomization
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 |
|---|---|---|---|
| GS-98-902 | None | None | None |