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| Sponsor: | Gilead Sciences |
|---|---|
| Information provided by: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT00772902 |
Purpose
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 |
| Enrollment: | 85 |
| Study Start Date: | October 2008 |
| Study Completion Date: | October 2009 |
| Primary Completion Date: | September 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Austria | |
| Gilead Sciences | |
| Vienna, Austria, 1220 | |
| Germany | |
| Gilead Sciences | |
| Munich, Germany | |
| Italy | |
| Gilead Sciences | |
| Milan, Italy | |
| Spain | |
| Gilead Sciences | |
| Madrid, Spain | |
| Study Director: | Florian Abel | Gilead Sciences |
More Information
| Responsible Party: | Gilead Sciences ( Florian Abel ) |
| Study ID Numbers: | GS-EU-164-0206 |
| Study First Received: | October 13, 2008 |
| Last Updated: | November 20, 2009 |
| ClinicalTrials.gov Identifier: | NCT00772902 History of Changes |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
HIV-1 LDL HDL |
non-HDL cholesterol triglycerides cholesterol |
|
Anti-Infective Agents HIV Protease Inhibitors Anti-HIV Agents Molecular Mechanisms of Pharmacological Action Lamivudine Enzyme Inhibitors Antiviral Agents Pharmacologic Actions Protease Inhibitors Reverse Transcriptase Inhibitors |
Lopinavir Emtricitabine Anti-Retroviral Agents Ritonavir Therapeutic Uses Tenofovir Abacavir Nucleic Acid Synthesis Inhibitors Tenofovir disoproxil |