- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01614626
Alcohol's Impact on Inflammatory Markers in HIV Disease - Russia ARCH Cohort
Alcohol & Zinc Impact on Inflammatory Markers in HIV Disease - Russia ARCH Cohort
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Heavy alcohol consumption in an HIV-infected person may accelerate HIV disease progression and end organ disease with one leading explanatory pathway being via enhanced microbial translocation and inflammation/altered coagulation. Heavy alcohol consumption and HIV infection are both causes of microbial translocation, the process by which bacterial products leak across the gastrointestinal membrane with resultant destructive immune activation. Among HIV-infected people, high levels of microbial translocation (as measured by soluble CD14) and inflammation/altered coagulation (as measured by IL-6 and D-dimer) are each associated with an increased risk of death. Of importance, among HIV-infected persons, heavy drinking is also significantly associated with higher levels of D-dimer in cross-sectional studies. Of note, initiation of antiretroviral therapy (ART) is associated with a reduction in D-dimer levels. Yet the following is not known: is there a longitudinal relationship between alcohol consumption and these biomarkers independent of ART?
Thus, as part of the Uganda, Russia, Boston Alcohol Network for Alcohol Research Collaboration on HIV/AIDS (URBAN ARCH)Consortium, the investigators seek to create the Russia ARCH cohort (n=375) from participants of a recently completed NIAAA-funded randomized controlled trial (RCT) of HIV infected Russian heavy drinkers.
The investigators will be collecting blood from participants at baseline, and at 12- and 24-months post enrollment. In addition to collecting and storing blood samples the investigators will be administering surveys to participants at all 3 timepoints. The investigators will conduct phone interviews with participants at 6- and 18-months post enrollment. The investigators will conduct laboratory tests on the stored samples, including measures of microbial translocation (sCD14) and inflammation/altered coagulation (IL-6/D-dimer) and PEth.
This study will clarify the association between alcohol and key biomarkers over time in HIV-infected heavy drinkers. In addition, the investigators will be collecting and storing blood samples from participants in the study to use for the analyses specified and for future studies looking at HIV-infected heavy drinkers.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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-
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St. Petersburg, Den russiske føderasjonen
- Pavlov State Medical University
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Age 18-70 years old
- HIV-infected
- Provision of contact information for two contacts to assist with follow-up
- Stable address within St. Petersburg or districts within 100 kilometers of St. Petersburg
- Possession of a home or mobile phone
- ART-naive at the time of enrollment
Exclusion Criteria:
- Not fluent in Russian
- Cognitive impairment resulting in inability to provide informed consent
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
- Tidsperspektiver: Potensielle
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Microbial translocation as measured by soluble CD14 (sCD14)
Tidsramme: Participants will be followed for up to 3 years
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Participants will be followed for up to 3 years
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Inflammation/altered coagulation as measured by IL-6/D-dimer
Tidsramme: Participants will be followed for up to 3 years
|
Participants will be followed for up to 3 years
|
Alcohol's association with immunologic aging as measured by flow cytometry
Tidsramme: Participants will be followed for up to 3 years
|
Participants will be followed for up to 3 years
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Jeffrey Samet, MD, MA, MPH, Boston Medical Center
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- H-31200
- U01AA020780 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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