Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2026-03-08 @ 3:30 AM
Study NCT ID:
NCT00772902
Status:
COMPLETED
Last Update Posted:
2011-11-21
First Post:
2008-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ROCKET II - Randomized Open Label Switch for Cholesterol Elevation on Kivexa + Kaletra Evaluation Trial
Sponsor:
Gilead Sciences
Organization:
Study Overview
Official Title:
A Phase 4, Open Label, Randomized, Controlled Study to Assess the Effect on Lipid Profile of Switching a Stable HAART Regimen of Fixed Dose Abacavir/Lamivudine (Kivexa) Plus Lopinavir/Ritonavir (Kaletra), to Emtricitabine/Tenofovir Disoproxil Fumarate (Truvada) Plus Lopinavir/Ritonavir (Kaletra) in Adult HIV-1 Infected Subjects With Raised Cholesterol
Status:
COMPLETED
Status Verified Date:
2011-11
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:
ROCKET II
Brief Summary:
This study investigated whether human immunodeficiency virus type 1 (HIV-1) infected subjects with raised cholesterol switching their nucleoside reverse transcriptase inhibitor (NRTI) backbone from Kivexa (Epzicom) to Truvada had an improvement in their fasting total cholesterol after 12 weeks of treatment. The study also investigated whether any improvement had a beneficial effect on the overall cardiovascular risk.
Detailed Description:
This was a Phase 4, open-label, randomized, multicenter (in the European Union), controlled study to assess the effect on lipid profile of switching from a stable highly active antiretroviral therapy (HAART) regimen of Kivexa + Kaletra to Truvada + Kaletra in adult HIV-1 infected subjects with raised cholesterol.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2008-002043-16 | EUDRACT_NUMBER | None | View |