- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00998582
Artery Elasticity After Switch From Epzicom to Truvada
3. oktober 2012 oppdatert av: Hennepin Healthcare Research Institute
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.
Studieoversikt
Studietype
Intervensjonell
Registrering (Faktiske)
27
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Minnesota
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Minneapolis, Minnesota, Forente stater, 55415
- Hennepin County Medical Center
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Minneapolis, Minnesota, Forente stater
- Abbott Northwestern Hospital and Clinics
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Aktiv komparator: Abacavir
Participants randomized to this arm will continue abacavir and their other HIV medications with no changes
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Participants taking an abacavir-based HIV treatment regimen will be randomized to switch to a tenofovir-based regimen or continue taking abacavir.
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Eksperimentell: 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
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Participants taking an abacavir-based HIV treatment regimen will be randomized to switch to a tenofovir-based regimen or continue taking abacavir.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Change in Small Artery Elasticity (mL/mmHg x100) From Baseline to Week 24
Tidsramme: Change from baseline to 24 weeks
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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.
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Change from baseline to 24 weeks
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Outcome Was Change in Large Artery Elasticity (mL/mmHg x100) From Baseline to Week 24
Tidsramme: Change from baseline to 24 weeks
|
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.
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Change from baseline to 24 weeks
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Jason Baker, MD, MS, University of Minnesota; HCMC
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. oktober 2009
Primær fullføring (Faktiske)
1. juni 2011
Studiet fullført (Faktiske)
1. desember 2011
Datoer for studieregistrering
Først innsendt
19. oktober 2009
Først innsendt som oppfylte QC-kriteriene
19. oktober 2009
Først lagt ut (Anslag)
20. oktober 2009
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
8. oktober 2012
Siste oppdatering sendt inn som oppfylte QC-kriteriene
3. oktober 2012
Sist bekreftet
1. oktober 2012
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- RNA-virusinfeksjoner
- Virussykdommer
- Infeksjoner
- Blodbårne infeksjoner
- Smittsomme sykdommer
- Seksuelt overførbare sykdommer, virale
- Seksuelt overførbare sykdommer
- Lentivirus infeksjoner
- Retroviridae-infeksjoner
- Immunologiske mangelsyndromer
- Sykdommer i immunsystemet
- HIV-infeksjoner
- Molekylære mekanismer for farmakologisk virkning
- Anti-infeksjonsmidler
- Antivirale midler
- Revers transkriptasehemmere
- Nukleinsyresyntesehemmere
- Enzymhemmere
- Anti-HIV-midler
- Antiretrovirale midler
- Tenofovir
Andre studie-ID-numre
- PCC-004
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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