Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Gilead Sciences |
---|---|
Information provided by: | Gilead Sciences |
ClinicalTrials.gov Identifier: | NCT00772902 |
This study aims to investigate whether subjects switching their NRTI backbone from Kivexa to Truvada, who already have raised total cholesterol prior to switching, have an improvement in their total cholesterol after 12 weeks of treatment. If an improvement is demonstrated the study aims to show whether this has a beneficial effect on the patient's overall cardiovascular risk and long term prognosis.
Condition | Intervention | Phase |
---|---|---|
HIV-1 |
Drug: Truvada (emtricitabine 200 mg/tenofovir DF 300 mg) and Kaletra (lopinavir 200 mg/ritonavir Drug: Kivexa (abacavir (as sulfate) 600 mg/lamivudine and Kaletra (lopinavir 200 mg/ritonavir |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study |
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 |
Estimated Enrollment: | 160 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Open label Truvada (emtricitabine 200 mg/tenofovir DF 300 mg) once daily for oral administration according to prescription information. As third agent continuing Kaletra (lopinavir 200 mg/ritonavir 50 mg) for oral administration according to prescription.
|
Drug: Truvada (emtricitabine 200 mg/tenofovir DF 300 mg) and Kaletra (lopinavir 200 mg/ritonavir
Open label Truvada (emtricitabine 200 mg/tenofovir DF 300 mg) once daily for oral administration according to prescription information. As third agent continuing Kaletra (lopinavir 200 mg/ritonavir 50 mg) for oral administration according to prescription. |
2: Active Comparator
Continuing Kivexa (abacavir (as sulfate) 600 mg/lamivudine 300 mg) once daily for oral administration according to prescription. As third agent continuing Kaletra (lopinavir 200 mg/ritonavir 50 mg) for oral administration according to prescription.
|
Drug: Kivexa (abacavir (as sulfate) 600 mg/lamivudine and Kaletra (lopinavir 200 mg/ritonavir
Continuing Kivexa (abacavir (as sulfate) 600 mg/lamivudine 300 mg) once daily for oral administration according to prescription. As third agent continuing Kaletra (lopinavir 200 mg/ritonavir 50 mg) for oral administration according to prescription. |
This is a Phase 4, open-label, randomized, EU multicenter, controlled study to assess the effect on lipid profile of switching from a stable HAART regimen of Kivexa + Kaletra to Truvada + Kaletra in adult HIV-1 infected subjects with raised cholesterol.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lothar Gallo | +498989989018 | lothar.gallo@gilead.com |
Germany | |
Gilead Sciences | Recruiting |
Munich, Germany | |
Contact: Lothar Gallo +4908989989018 lothar.gallo@gilead.com | |
Italy | |
Gilead Sciences | Recruiting |
Milan, Italy | |
Contact: Loredana Balzano +39 02 43920239 RosariaLoredana.Balzano@gilead.com | |
Spain | |
Gilead Sciences | Recruiting |
Madrid, Spain | |
Contact: Ana Moreno +34 91 378 98 30 ana.moreno@gilead.com |
Study Director: | Florian Abel | Gilead Sciences |
Responsible Party: | Gilead Sciences ( Florian Abel ) |
Study ID Numbers: | GS-EU-164-0206 |
Study First Received: | October 13, 2008 |
Last Updated: | December 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00772902 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
HIV-1 LDL HDL |
non-HDL cholesterol triglycerides cholesterol |
Lopinavir Emtricitabine Ritonavir HIV Infections Acquired Immunodeficiency Syndrome |
Tenofovir Lamivudine Abacavir Tenofovir disoproxil |
Anti-Infective Agents HIV Protease Inhibitors Anti-HIV Agents Anti-Retroviral Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Enzyme Inhibitors Antiviral Agents Pharmacologic Actions Nucleic Acid Synthesis Inhibitors Protease Inhibitors Reverse Transcriptase Inhibitors |