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| Sponsor: | Gilead Sciences |
|---|---|
| Information provided by (Responsible Party): | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT00772902 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV-1 |
Drug: Truvada + Kaletra Drug: Kivexa + Kaletra |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
|---|---|
|
Experimental: Truvada + Kaletra
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 + Kaletra
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.
|
|
Active Comparator: Kivexa + Kaletra
Continuing Kivexa (abacavir 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 + Kaletra
Continuing Kivexa (abacavir 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.
Other Name: Kivexa = Epzicom
|
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.
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 |
| ClinicalTrials.gov Identifier: | NCT00772902 History of Changes |
| Other Study ID Numbers: | GS-EU-164-0206, 2008-002043-16 |
| Study First Received: | October 13, 2008 |
| Last Updated: | November 18, 2011 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
HIV-1 LDL HDL |
non-HDL cholesterol triglycerides cholesterol |
|
Lamivudine Tenofovir disoproxil Tenofovir Abacavir Ritonavir Lopinavir Emtricitabine Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents HIV Protease Inhibitors Protease Inhibitors |