Clinical Trials Logo
  1. Home
  2. Alcohol Use
  3. NCT01614626

Alcohol's Impact on Inflammatory Markers in HIV Disease - Russia ARCH Cohort

HIV Infection Clinical Trial

Official title:
Alcohol & Zinc Impact on Inflammatory Markers in HIV Disease - Russia ARCH Cohort

Clinical Trial Summary

The purpose of this study is to assess the longitudinal association between alcohol consumption and biomarkers of microbial translocation (sCD14) and inflammation/altered coagulation (IL-6/D-dimer); to establish a cohort of HIV-infected Russian drinkers; and to establish a sample repository.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01614626
Study type Observational
Source Boston Medical Center
Contact
Status Completed
Phase
Start date November 2012
Completion date December 15, 2020
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT02135419 - Treatment in Preventing Anal Cancer in Patients With HIV and Anal High-Grade Lesions Phase 3
Active, not recruiting NCT02663856 - My Smart Age With HIV: Smartphone Self-assessment of Frailty
Completed NCT02921516 - Growing Up: Intervening With HIV-Positive Adolescents in Resource-Poor Settings N/A
Completed NCT02659306 - Metformin Immunotherapy in HIV Infection Phase 1
Terminated NCT02743598 - Liraglutide for HIV-associated Neurocognitive Disorder Phase 4
Completed NCT02846402 - Impact of HIV Self-testing Among Female Sex Workers in Kampala, Uganda N/A
Completed NCT02663869 - Aging With HIV at Younger vs Older Age: a Diverse Population With Distinct Comorbidity Profiles
Completed NCT02564341 - Targeting Effective Analgesia in Clinics for HIV - Intervention N/A
Active, not recruiting NCT02302950 - A Retrospective Analysis of Raltegravir Use in Minority HIV Infected Women in Houston, Texas N/A
Terminated NCT02109224 - Ibrutinib in Treating Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma in Patients With HIV Infection Phase 1
Completed NCT02269605 - Bryostatin-1 Effect on HIV-1 Latency and Reservoir in HIV-1 Infected Patients Receiving Antiretroviral Treatment Phase 1
Completed NCT01852942 - Reversing Tissue Fibrosis to Improve Immune Reconstitution in HIV Phase 2
Terminated NCT01902186 - Bone Mineral Density Changes in HIV-positive Females With Osteopenia Switching to Raltegravir Phase 4
Completed NCT01830595 - Lactoferrin Treatment in HIV Patients Phase 2
Completed NCT02525146 - Birmingham Access to Care Study N/A
Completed NCT01946217 - Factors Affecting Patient Participation in AIDS Malignancy Clinical Trials Consortium Clinical Trials N/A
Completed NCT02118168 - Observational Study for the Extended Follow-up of the Patients Enrolled in the Therapeutic Clinical Trial ISS T-002 N/A
Completed NCT02527135 - Text Messaging to Improve HIV Testing Among Young Women in Kenya N/A
Active, not recruiting NCT02602418 - Neural Correlates of Working Memory Training for HIV Patients N/A
Completed NCT01680094 - Safety and Effect of The HDAC Inhibitor Panobinostat on HIV-1 Expression in Patients on Suppressive HAART Phase 1/Phase 2