Redistribution of Fat and Metabolic Change in HIV Infection: Protocol 2 (FRAM Fat 2)

NCT ID: NCT00244803

Last Updated: 2016-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

101 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-01-31

Study Completion Date

2007-05-31

Brief Summary

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The purpose of this study is to learn whether HIV-infected patients have blood abnormalities which could lead to heart attack or stroke, and to find out what factors may contribute to these abnormalities.

Detailed Description

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This research is being done to learn whether HIV-infected patients have abnormalities in their blood vessels that could eventually lead to heart attack or stroke (atherosclerosis), in how fat is distributed in their body and in how their body handles fat and sugars. If there are abnormalities, this study will also try to find out what factors may contribute to those abnormalitites.

People who participated in FRAM 1 may join FRAM 2.

Conditions

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Human Immunodeficiency Virus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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HIV Positive FRAM 1 Participant

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 18-65 years old
* previous FRAM 1 participant
* HIV positive

Exclusion Criteria

* Artificial knee or hip replacement or Harrington rod
* Metal objects in the body.Pregnancy
* Breastfeeding or less than 3 months after breastfeeding
* Weight more than 300 pound
* On insulin, pancreatic enzymes, or thioridazine.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joseph Cofrancesco Jr., M.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins University, The Clinical Trials Unit

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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Lake JE, Wohl D, Scherzer R, Grunfeld C, Tien PC, Sidney S, Currier JS. Regional fat deposition and cardiovascular risk in HIV infection: the FRAM study. AIDS Care. 2011 Aug;23(8):929-38. doi: 10.1080/09540121.2010.543885. Epub 2011 Jun 24.

Reference Type DERIVED
PMID: 21767228 (View on PubMed)

Other Identifiers

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03-07-02-01

Identifier Type: -

Identifier Source: org_study_id

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