Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00100048
Status:
COMPLETED
Last Update Posted:
2015-09-09
First Post:
2004-12-22
Brief Title:
A Study to Evaluate the Safety and Efficacy of an Investigational Drug in HIV Infected Patients 0518-004COMPLETED
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
Multicenter Double-Blind Randomized Dose Ranging Study to Compare the Safety and Activity of MK0518 Plus Tenofovir and Lamivudine 3TC Versus Efavirenz Plus Tenofovir and Lamivudine 3TC in ART-Naive HIV-Infected Patients
Status:
COMPLETED
Status Verified Date:
2015-09
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:
This is a study that will investigate the safety and efficacy of an investigational drug in Human immunodeficiency virus HIV infected patients
Detailed Description:
Participants who completed 48 weeks of the original 48-week double-blind study were invited to continue in two extensions MK0518-004-10 NCT00100048 which extended the study to 144 weeks and MK0518-004-20 NCT00100048 which extended the study to 240 weeks Participants who had been randomized to MK0518 in the base study continued at 400 mg MK0518 twice daily
Participants randomized to efavirenz in the base study continued to receive efavirenz at the dosage given in the base study The doses of open label tenofovir and lamivudine continued unchanged
Participants randomized to efavirenz in the base study continued to receive efavirenz at the dosage given in the base study The doses of open label tenofovir and lamivudine continued unchanged
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2004_096 | None | None | None |