Trial record 7 of 31 for:    " November 21, 2012":" December 21, 2012"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Boston Alcohol Research Collaboration on HIV/AIDS (ARCH) Cohort

This study is currently recruiting participants.
Verified November 2012 by Boston Medical Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Richard Saitz, Boston Medical Center
ClinicalTrials.gov Identifier:
NCT01740115
First received: November 30, 2012
Last updated: NA
Last verified: November 2012
History: No changes posted
  Purpose

The purpose of this study is to expand and continue a cohort of HIV-infected adults to establish the longitudinal Boston ARCH Cohort of 250 HIV-infected men and women with current substance dependence or ever injection drug use that have a spectrum of alcohol use; and to determine the effect of alcohol consumption on changes in bone health prospectively in the Cohort.


Condition
HIV Infection
Alcohol Use
Bone Disease
Substance-Related Disorders

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Addressing Alcohol/HIV Consequences in Substance Dependence - Boston ARCH Cohort

Resource links provided by NLM:


Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • Annual mean percent change in hip (femoral neck) bone mineral density (g/cm2) [ Time Frame: Between study entry and final visit (minimum of 12 months) ] [ Designated as safety issue: No ]
    Bone mineral density will be measured using Hologic QDR 4500W enhanced-array, whole-body, dual-energy radiographic absorptiometry scanner and software, version 12.6.1 (Bone Densitometer)


Secondary Outcome Measures:
  • Annual mean percent change in spine (trabecular bone) bone mineral density (g/cm2) [ Time Frame: Between study entry and final visit (minimum of 12 months) ] [ Designated as safety issue: No ]
    Bone mineral density will be measured using Hologic QDR 4500W enhanced-array, whole-body, dual-energy radiographic absorptiometry scanner and software, version 12.6.1 (Bone Densitometer) Safety Issue?: No

  • Proportion with bone mineral density decrease of >6% [ Time Frame: Between study entry and final visit (minimum of 12 months) ] [ Designated as safety issue: No ]
    Bone mineral density will be measured using Hologic QDR 4500W enhanced-array, whole-body, dual-energy radiographic absorptiometry scanner and software, version 12.6.1 (Bone Densitometer)

  • Proportion with osteopenia (bone mineral density t score -1 to -2.5 SDs compared to a young adult reference population mean) [ Time Frame: Between study entry and final visit (minimum of 12 months) ] [ Designated as safety issue: No ]
    Bone mineral density will be measured using Hologic QDR 4500W enhanced-array, whole-body, dual-energy radiographic absorptiometry scanner and software, version 12.6.1 (Bone Densitometer)

  • Proportion of osteoporosis (bone mineral density t score <-2.5 SDs compared to a young adult reference population mean) [ Time Frame: Between study entry and final visit (minimum of 12 months) ] [ Designated as safety issue: No ]
    Bone mineral density will be measured using Hologic QDR 4500W enhanced-array, whole-body, dual-energy radiographic absorptiometry scanner and software, version 12.6.1 (Bone Densitometer)

  • Fractures (vertebral, hip, wrist) [ Time Frame: 12 months prior to study entry through final visit ] [ Designated as safety issue: No ]
    Self-report of ever fracture at each site (vertebral, hip, wrist) and fracture in past 12-months collected at baseline and each annual time point.

  • Annual mean percent change in bone mineral density (g/cm2) at site with lowest bone mineral density (spine [trabecular bone] or hip [femoral neck]) [ Time Frame: Between study entry and final visit (minimum of 12 months) ] [ Designated as safety issue: No ]
    Bone mineral density will be measured using Hologic QDR 4500W enhanced-array, whole-body, dual-energy radiographic absorptiometry scanner and software, version 12.6.1 (Bone Densitometer)


Other Outcome Measures:
  • Bone mineral density, bone mineral content, trabecular thickness, separation and number, volume fraction and cortical thickness [ Time Frame: Between study entry and final visit (minimum of 12 months) ] [ Designated as safety issue: No ]
    Exploratory outcomes will be assessed using HR-pQCT (wrist and ankle)


Biospecimen Retention:   Samples With DNA

We are storing serum and plasma for future use. We are also storing dried blood spots.


Estimated Enrollment: 250
Study Start Date: November 2012
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Detailed Description:

Unhealthy alcohol use (i.e. the spectrum ranging from heavy drinking that risks health consequences to dependence) is common among HIV-infected persons and is associated with worse health outcomes among people with HIV infection. However, much remains unknown about alcohol-related health effects in those affected by multiple drugs (particularly opioids), or about specific health effects such as detriment to bone. Alcohol use can disrupt bone remodeling by suppressing formation and increasing resorption; heavy alcohol use is associated with both osteopenia (low bone mineral density [BMD]) and incidence of fractures. Osteopenia is common among HIV-infected patients, and fractures are more common in these patients than among adults without HIV infection. Duration of HIV infection has been found to be associated with low BMD, and antiretroviral therapy (ART) also appears to be associated with BMD decline. While bone health is likely affected by HIV infection, ART, alcohol and other drug (e.g. opioid) use (in addition to other known risk factors), the alcohol-osteopenia association among those with HIV infection is not well-characterized. It is not known whether there is an association, the magnitude and nature of that association, and how the relationship is affected by other commonly co-occurring factors (e.g. opioid use, ART).

Accordingly, as part of the Uganda Russia Boston Alcohol Network for Alcohol Research Collaboration on HIV/AIDS (URBAN ARCH) Consortium, we seek to expand and continue a cohort of HIV-infected adults to establish the Boston ARCH Cohort of 250 HIV-infected adults affected by multiple substances and that have a spectrum of alcohol use. This observational prospective cohort study will involve in-person assessments that will take place at 6-month intervals; participants will be followed for a minimum of 1 year and a maximum of 3.5 years. All assessments will include a researcher-administered questionnaire and breath alcohol test. In addition, the baseline assessment and each annual assessment (12, 24 or 36 months after enrollment) will also include: a urine pregnancy test (females only), blood collection, measurement of bone mineral density of the hip and spine (using Hologic QDR 4500W enhanced-array, whole-body, dual-energy radiographic absorptiometry [Bone Densitometer]), and measurement of bone microarchitecture of the wrist and ankle (using Xtreme CT [a device that measures high-resolution three-dimensional peripheral quantitative computed tomography]). We will conduct laboratory tests on blood samples collected at these time points, including tests for 25(OH) vitamin D3 and phosphatidylethanol (PEth). Remaining plasma and serum samples will be stored for future study of bone markers such as: parathyroid hormone, testosterone, carboxy-terminal collagen crosslinks (CTX) (a marker of osteoclast activity), and osteocalcin (osteoblast activity).

In summation, this study will measure the effect of alcohol consumption on changes in bone health prospectively in HIV-infected adults with current substance dependence or ever injection drug use. To our knowledge, no other prospective HIV/bone study has studied these relevant factors simultaneously or used HR-pQCT to assess bone microarchitecture. Data on alcohol risks to bone health is important information for defining risky drinking amounts for people with HIV infection (and for advising such patients accordingly).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects from an existing cohort of HIV-infected adults (Facilitated Access to Substance Abuse Treatment With Prevention and Treatment of HIV [FAST PATH]) who have indicated interest in future studies and patients from HIV clinical care sites will be recruited.

Criteria

Inclusion Criteria:

  1. Documented HIV antibody by ELISA confirmed by Western Blot or current HIV viral load greater than 10,000 in any medical record
  2. Current (12-month) substance dependence, determined by using the Mini International Neuropsychiatric Interview (MINI) or ever injection drug use (IDU)
  3. Ability to speak English (fluency)
  4. At least one contact person who is likely to know whereabouts (to assist with follow-up)

Exclusion Criteria:

  1. Under age 18
  2. Pregnancy (confirmed by urine test)
  3. Plans to leave Boston area in <1 year
  4. Inability to consent or understand interview (determined by trained research assistant)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01740115

Locations
United States, Massachusetts
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Alicia Ventura, MPH    617-414-6914    alicia.ventura@bmc.org   
Contact: Seville Meli, MPH    617-414-6917    seville.meli@bmc.org   
Sponsors and Collaborators
Boston Medical Center
Investigators
Principal Investigator: Richard Saitz, MD, MPH Boston Medical Center
  More Information

No publications provided

Responsible Party: Richard Saitz, Director, Clinical Addiction Research and Education (CARE) Unit, Section of General Internal Medicine, Boston Medical Center
ClinicalTrials.gov Identifier: NCT01740115     History of Changes
Other Study ID Numbers: U01AA020784, U01AA020784
Study First Received: November 30, 2012
Last Updated: November 30, 2012
Health Authority: United States: Institutional Review Board
United States: Data and Safety Monitoring Board
United States: Federal Government

Keywords provided by Boston Medical Center:
HIV
Alcohol Use
Bone Disease
Bone Mineral Density
Bone Microarchitecture
Substance Dependence

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Alcohol Drinking
Bone Diseases
Substance-Related Disorders
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Drinking Behavior
Musculoskeletal Diseases
Mental Disorders

ClinicalTrials.gov processed this record on April 16, 2014