Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00244803
First received: October 25, 2005
Last updated: August 30, 2016
Last verified: August 2016

October 25, 2005
August 30, 2016
January 2005
May 2007   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00244803 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Redistribution of Fat and Metabolic Change in HIV Infection: Protocol 2 (FRAM Fat 2)
Redistribution and Metabolic Change in HIV Infection: Protocol 2 (FRAM Fat 2)
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
men or women 18-65 years old, previous FRAM 1 participant, HIV positive
Human Immunodeficiency Virus
Not Provided
HIV Positive FRAM 1 Participant
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
101
May 2007
May 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00244803
03-07-02-01
Yes
Not Provided
Not Provided
Johns Hopkins University
Johns Hopkins University
National Institutes of Health (NIH)
Principal Investigator: Joseph Cofrancesco Jr., M.D. Johns Hopkins University
Johns Hopkins University
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP