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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00244803
First Posted: October 27, 2005
Last Update Posted: August 31, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Johns Hopkins University
  Purpose
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.

Condition
Human Immunodeficiency Virus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Redistribution and Metabolic Change in HIV Infection: Protocol 2 (FRAM Fat 2)

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Enrollment: 101
Study Start Date: January 2005
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
HIV Positive FRAM 1 Participant

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
men or women 18-65 years old, previous FRAM 1 participant, HIV positive
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00244803


Locations
United States, Maryland
Johns Hopkins University, The Clinical Trials Unit
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
National Institutes of Health (NIH)
Investigators
Principal Investigator: Joseph Cofrancesco Jr., M.D. Johns Hopkins University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00244803     History of Changes
Other Study ID Numbers: 03-07-02-01
First Submitted: October 25, 2005
First Posted: October 27, 2005
Last Update Posted: August 31, 2016
Last Verified: August 2016

Keywords provided by Johns Hopkins University:
Human Immunodeficiency Virus
FRAM 1

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immune System Diseases
Slow Virus Diseases