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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-003354-28 EudraCT Number |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atripla | Drug | Open label once daily for oral administration to be taken on an empty stomach |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in total fasting cholesterol at Week 12. | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in total fasting cholesterol at Week 24 | 24 fweeks | |
| Changes in fasting LDL, HDL, triglycerides, non-HDL cholesterol and cholesterol ratios | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cham Herath | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gilead Sciences | Granta Park, Cambridge | Abington | CB21 6GT | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25658097 | Derived | Moyle GJ, Orkin C, Fisher M, Dhar J, Anderson J, Wilkins E, Ewan J, Ebrahimi R, Wang H; ROCKET 1 (Randomized Open Label Switch for Cholesterol Elevation on Kivexa Evaluation Trial) Study Group. A randomized comparative trial of continued abacavir/lamivudine plus efavirenz or replacement with efavirenz/emtricitabine/tenofovir DF in hypercholesterolemic HIV-1 infected individuals. PLoS One. 2015 Feb 6;10(2):e0116297. doi: 10.1371/journal.pone.0116297. eCollection 2015. |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D000068257 | Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| C492871 | abacavir, lamivudine drug combination |
| C098320 | efavirenz |
| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| Kivexa plus Sustiva |
| Drug |
Open label once daily for oral administration |
|
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D010078 |
| Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000068679 | Emtricitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |