|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Gilead Sciences |
|---|---|
| Information provided by: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT00615810 |
Purpose
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: | 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 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 |
| Enrollment: | 159 |
| Study Start Date: | March 2008 |
| Study Completion Date: | January 2010 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 2
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
|
Drug: Kivexa plus Sustiva
Open label once daily for oral administration
|
|
Experimental: 1
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
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
More Information
| Responsible Party: | Cham Herath, Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT00615810 History of Changes |
| Other Study ID Numbers: | GS-UK-177-0109, 2007-003354-28 EudraCT Number |
| Study First Received: | February 1, 2008 |
| Last Updated: | July 30, 2010 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
|
LDL HDL triglycerides non HDL cholesterol |
cholesterol HIV 1 Metabolic parameters treatment experienced |
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Efavirenz |
Efavirenz, emtricitabine, tenofovir disoproxil fumarate drug combination 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 |