|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Minneapolis Medical Research Foundation |
|---|---|
| Information provided by: | Minneapolis Medical Research Foundation |
| ClinicalTrials.gov Identifier: | NCT00998582 |
Purpose
Recent research as suggested that use of the HIV medication abacavir (Ziagen, or co-formulated with lamivudine as Epzicom) may increase risk for heart disease, though findings from multiple studies have been inconsistent. This pilot study will examine vascular function, a marker of heart disease risk, among patients taking abacavir as part of their HIV medications and are then randomized to: 1) switch to tenofovir, another HIV medication, or 2) continue to take abacavir.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Tenofovir disoproxil |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment |
| Official Title: | Artery Elasticity After Switch From Epzicom to Truvada |
| Estimated Enrollment: | 70 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Abacavir: Active Comparator
Participants randomized to this arm will continue abacavir and their other HIV medications with no changes
|
Drug: Tenofovir disoproxil
Participants taking an abacavir-based HIV treatment regimen will be randomized to switch to a tenofovir-based regimen or continue taking abacavir.
|
|
Tenofovir: Experimental
Participants randomized to this arm will switch from taking abacavir (co-formulated with lamivudine as Epzicom) and start taking tenofovir (co-formulated with emtricitabine as Truvada), and continue their other HIV medications
|
Drug: Tenofovir disoproxil
Participants taking an abacavir-based HIV treatment regimen will be randomized to switch to a tenofovir-based regimen or continue taking abacavir.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate renal function defined as a calculated creatinine clearance (CLCr) ≥50 mL/min according to the Cockcroft-Gault formula:
Exclusion Criteria:
Receiving ongoing therapy with any of the following (administration of any of the following medications must be discontinued at least 30 days prior to the baseline visit and for the duration of the study period):
Contacts and Locations| Contact: Jason Baker, MD | 612-873-2705 | baker459@umn.edu |
| Contact: Rachel Prosser, CNP | 612-873-2877 | Rachel.Prosser@hcmed.org |
| United States, Minnesota | |
| Hennepin County Medical Center | Recruiting |
| Minneapolis, Minnesota, United States, 55415 | |
| Contact: Rachel Prosser, CNP 612-873-2788 rachel.prosser@hcmed.org | |
| Principal Investigator: Jason Baker, MD, MS | |
| Abbott Northwestern Hospital and Clinics | Not yet recruiting |
| Minneapolis, Minnesota, United States | |
| Contact: Deb Wood Deborah.Wood@allina.com | |
| Principal Investigator: Frank Rhame, MD | |
| Principal Investigator: | Jason Baker, MD, MS | University of Minnesota; HCMC |
More Information
| Responsible Party: | Hennepin County Medical Center ( Rachel Prosser, or Jason Baker ) |
| Study ID Numbers: | PCC-004 |
| Study First Received: | October 19, 2009 |
| Last Updated: | November 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00998582 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Cardiovascular Disease HIV Infection Abacavir Artery Elasticity Treatment experienced |
|
Communicable Diseases Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Tenofovir Retroviridae Infections Nucleic Acid Synthesis Inhibitors Tenofovir disoproxil |
RNA Virus Infections Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections |