Artery Elasticity After Switch From Epzicom to Truvada

This study has been terminated.
(Low enrollment)
Sponsor:
Information provided by (Responsible Party):
Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier:
NCT00998582
First received: October 19, 2009
Last updated: October 3, 2012
Last verified: October 2012

October 19, 2009
October 3, 2012
October 2009
June 2011   (final data collection date for primary outcome measure)
  • Change in Small Artery Elasticity (mL/mmHg x100) From Baseline to Week 24 [ Time Frame: Change from baseline to 24 weeks ] [ Designated as safety issue: No ]
    Small artery elasticity is a measure of vascular function, estimated through analysis of the blood pressure waveform. A sensor is placed on wrist over the radial pulse. The blood pressure waveform of the pulse is recorded and analyzed the elasticity, or compliance, of the small (and large) vasculature. Impaired artery elasticity, or increased stiffness, is an early sign of vascular disease that predicts risk for future cardiovascular events.
  • Outcome Was Change in Large Artery Elasticity (mL/mmHg x100) From Baseline to Week 24 [ Time Frame: Change from baseline to 24 weeks ] [ Designated as safety issue: No ]
    Large artery elasticity is a measure of vascular function, estimated through analysis of the blood pressure waveform. A sensor is placed on wrist over the radial pulse. The blood pressure waveform of the pulse is recorded and analyzed the elasticity, or compliance, of the large (and small) vasculature. Impaired artery elasticity, or increased stiffness, is an early sign of vascular disease.
  • Small and large artery elasticity [ Time Frame: 24 and 48 weeks ] [ Designated as safety issue: No ]
  • Biomarkers of endothelial activation [ Time Frame: 12 to 24 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00998582 on ClinicalTrials.gov Archive Site
Not Provided
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Artery Elasticity After Switch From Epzicom to Truvada
Artery Elasticity After Switch From Epzicom to Truvada

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
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.
  • Active Comparator: Abacavir
    Participants randomized to this arm will continue abacavir and their other HIV medications with no changes
    Intervention: Drug: Tenofovir disoproxil
  • Experimental: Tenofovir
    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
    Intervention: Drug: Tenofovir disoproxil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
27
December 2011
June 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult (≥18 years) males or non-pregnant females, non-lactating females.
  • HIV-infected participants currently receiving fixed-dose abacavir/lamivudine based regimen for ≥3 months preceding the screening visit.
  • HIV-infection documented by a positive HIV-1 antibody (confirmatory western-blot) or an HIV RNA level ≥1000 copies/mL
  • Two consecutive plasma HIV RNA concentrations below the limit of detection for clinical-based assays used for HCMC and ANW HIV clinics. The 1st HIV RNA concentration must be at least 3 months prior to study entry.
  • Subjects receiving lipid lowering agents will be allowed; however, dosing for these medications must be stable for ≥3 months prior to study entry
  • Adequate renal function defined as a calculated creatinine clearance (CLCr) ≥50 mL/min according to the Cockcroft-Gault formula:

    • MALE: (140 - age in years) x (wt in kg) = CLCr (mL/min) 72 x (serum creatinine in mg/dL)
    • FEMALE: (140 - age in years) x (wt in kg) x 0.85 = CLCr (mL/min) 72 x (serum creatinine in mg/dL)
  • Negative serum pregnancy test (females of childbearing potential only)
  • Hepatic transaminases (AST and ALT) ≤ 5 x upper limit of normal (ULN).
  • Males and females (of childbearing potential) must agree to avoid pregnancy by sexual abstinence, or utilization of a highly effective method of birth control throughout the study period and for 30 days following discontinuation of study drug (refer to Appendix A for definitions of 'childbearing potential' and 'highly effective method of birth control')

Exclusion Criteria:

  • Subjects with known resistance to abacavir, lamivudine, tenofovir DF, or emtricitabine at anytime in the past (including but not limited to K65R, L74V/I, M184V/I, or thymidine analog mutations).
  • A new AIDS-defining condition diagnosed (with the exception of CD4 criteria) within 30 days of baseline
  • Previous therapy with agents with systemic myelosuppressive, pancreatoxic, hepatotoxic or cytotoxic potential within 3 months of study entry or the expectation for such therapy at the time of enrollment
  • Proven or suspected acute hepatitis in the 30 days prior to study entry
  • 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):

    • Nephrotoxic agents (aminoglycoside antibiotics, amphotericin B, cidofovir, cisplatin, foscarnet, IV pentamidine, other agents with significant nephrotoxic potential)
    • Adefovir dipivoxil
    • Probenecid
    • Systemic chemotherapeutic agents (i.e., cancer treatment medications)
    • Systemic corticosteroids
    • Interleukin-2 (IL-2)
  • Evidence of gastrointestinal malabsorption syndrome or chronic nausea or vomiting which may confer an inability to receive an orally administered medication.
  • Current alcohol or substance abuse judged by the investigator to potentially interfere with subject adherence
  • Malignancy other than cutaneous Kaposi's sarcoma (KS) or basal cell carcinoma. Participants with biopsy-confirmed cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of baseline and are not anticipated to require systemic therapy during the study.
  • Active, serious infections (other than HIV-1 infection) requiring parenteral antimicrobial therapy within 15 days prior to screening.
  • Prior history of significant renal or bone disease.
  • Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements.
  • Known hypersensitivity to the study drugs, the metabolites or formulation excipients
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00998582
PCC-004
No
Minneapolis Medical Research Foundation
Minneapolis Medical Research Foundation
Not Provided
Principal Investigator: Jason Baker, MD, MS University of Minnesota; HCMC
Minneapolis Medical Research Foundation
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP