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Sponsored by: |
Gilead Sciences |
---|---|
Information provided by: | Gilead Sciences |
ClinicalTrials.gov Identifier: | NCT00615810 |
This study aims to investigate whether patients switching their 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 Infections |
Drug: Atripla Drug: Kivexa plus Sustiva |
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 From a Stable HAART Regimen of Fixed Dose Abacavir/Lamivudine (Kivexa) Plus Efavirenz, to Once Daily Atripla in Adult HIV-1 Infected Subjects With Raised Cholesterol |
Estimated Enrollment: | 180 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
2: Active Comparator
Open label Kivexa (abacavir (as sulfate) 600 mg/lamivudine 300 mg) once daily for oral administration plus Sustiva (efavirenz 600 mg) once daily for oral administration
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Drug: Kivexa plus Sustiva
Open label once daily for oral administration
|
1: Experimental
Open label Atripla (efavirenz 600 mg/emtricitabine 200 mg/tenofovir DF 300 mg) once daily for oral administration to be taken on an empty stomach
|
Drug: Atripla
Open label once daily for oral administration to be taken on an empty stomach
|
This protocol is a Phase 4, open label, randomized, UK multi-center, controlled study to assess the effect on lipid profile of switching from a stable HAART regimen of Kivexa + EFV to once daily Atripla in adult HIV 1 infected subjects with raised cholesterol.
At Baseline, subjects will be randomized 1:1 to one of two treatment groups:
Treatment Group 1: switch to Atripla Treatment Group 2: Continuation of previous stable HAART regimen of Kivexa + EFV Initiation of treatment with study drugs must take place within 24 hours after Baseline visit. At Week 12, subjects in Treatment Group 2 (continuation of Kivexa and EFV regimen) will switch to Atripla. Treatment in both groups will continue through Week 24
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jacqueline Ewan | +44 (0) 1223 897416 | jacqueline.ewan@gilead.com |
United Kingdom, Abington | |
Gilead Sciences | Recruiting |
Granta Park, Cambridge, Abington, United Kingdom, CB21 6GT | |
Contact: Cham Herath +44 (0) 1223 897300 cham.herath@gilead.com |
Study Director: | Cham Herath | Gilead Sciences |
Responsible Party: | Gilead Sciences ( Cham Herath ) |
Study ID Numbers: | GS-UK-177-0109, 2007-003354-28 EudraCT Number |
Study First Received: | February 1, 2008 |
Last Updated: | November 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00615810 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
LDL HDL triglycerides non HDL cholesterol |
cholesterol HIV 1 Metabolic parameters treatment experienced |
Virus Diseases Efavirenz Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Lamivudine Abacavir Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |