Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002450
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-01-17
Brief Title:
Safety and Effectiveness of Tenofovir Disoproxil Fumarate Tenofovir DF Plus Other Anti-HIV Drugs in HIV-Infected Patients
Sponsor:
Gilead Sciences
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Phase III Double-Blind Randomized Placebo-Controlled Multicenter Study of the Safety and Efficacy of Tenofovir Disoproxil Fumarate in Combination With Other Antiretroviral Agents for the Treatment of HIV-1 Infected Patients
Status:
COMPLETED
Status Verified Date:
2000-07
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 giving tenofovir DF plus a combination of other anti-HIV drugs is safe and effective
Detailed Description:
Patients are randomized 21 to add tenofovir DF once daily or placebo to their existing antiretroviral regimen in a blinded manner Patients are stratified according to HIV-1 RNA level CD4 cell count and number of antiretroviral drugs taken prior to study entry Patients and physicians are strongly discouraged from making changes in their antiviral therapies for at least 24 weeks post-randomization After Week 24 changes in background antiretroviral therapy are permitted At 24 weeks post-randomization patients randomized to receive placebo are crossed over to receive open-label tenofovir DF once daily for the remainder of the 48-week study While on study drug patients are monitored for safety using periodic physical examinations and serial laboratory tests Additionally changes in plasma HIV RNA levels and CD4 cell counts are monitored to assess antiviral efficacy At the end of the 48-week study period patients are rolled over into extended dosing until tenofovir DF is commercially available or Gilead Sciences terminates the study
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-99-907 | None | None | None |