Ignite Creation Date:
2024-05-06 @ 8:51 AM
Last Modification Date:
2024-10-26 @ 12:05 PM
Study NCT ID:
NCT02831673
Status:
COMPLETED
Last Update Posted:
2023-08-24
First Post:
2016-07-08
Brief Title:
An Efficacy Safety and Tolerability Study Comparing Dolutegravir Plus Lamivudine With Dolutegravir Plus TenofovirEmtricitabine in Treatment naïve HIV Infected Subjects Gemini 1
Sponsor:
ViiV Healthcare
Organization:
ViiV Healthcare
Study Overview
Official Title:
A Phase III Randomised Double Blind Multicentre Parallel Group Non Inferiority Study Evaluating the Efficacy Safety and Tolerability of Dolutegravir Plus Lamivudine Compared to Dolutegravir Plus TenofovirEmtricitabine in Human Immunodeficiency Virus 1 Infected Treatment naïve Adults
Status:
COMPLETED
Status Verified Date:
2023-07
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:
This study will compare safety efficacy and tolerability of a two drug regimen of dolutegravir DTG plus lamivudine 3TC administered once daily with DTG plus two nucleoside reverse transcriptase inhibitors Tenofovir TDFEmtricitabine FTC fixed dose combination FDC administered once daily in human immunodeficiency virus HIV 1 infected adult participants that have not previously received antiretroviral therapy The study is designed to demonstrate the non-inferior antiviral activity of DTG plus 3TC regimen to that of DTG plus TDFFTC FDC and will characterise the long term antiviral activity tolerability and safety of DTG plus 3TC through Week 148 Approximately 700 participants will be randomised 11 to receive DTG 3TC or DTG TDFFTC FDC Participants will be stratified by screening HIV 1 ribonucleotide nucleic acid RNA levels and by screening CD4 cluster of differentiation 4 cell count
Detailed Description:
None
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 |
|---|---|---|---|
| 2015-004418-95 | EUDRACT_NUMBER | None | None |