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

Human Immunodeficiency Virus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00244803
• Other study ID #: 03-07-02-01
• Status: Completed
• Phase: N/A
• First received: October 25, 2005
• Last updated: August 30, 2016
• Start date: January 2005
• Est. completion date: May 2007

Study information

• Verified date: August 2016
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes

Locations

Country	Name	City	State
United States	Johns Hopkins University, The Clinical Trials Unit	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States,