Human Immunodeficiency VirusNCT00244803
Redistribution of Fat and Metabolic Change in HIV Infection: Protocol 2 (FRAM Fat 2)
An observational study of Human Immunodeficiency Virus, run by Johns Hopkins University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Human Immunodeficiency Virus
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to May 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: men or women 18-65 years old, previous FRAM 1 participant, HIV positive
Who may be able to join
- 18-65 years old
- previous FRAM 1 participant
- HIV positive
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University, The Clinical Trials Unit
Baltimore, Maryland, 21205
About this study
Official title: 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.
Read the 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.
- Conditions
- Human Immunodeficiency Virus
- Keywords
- Human Immunodeficiency Virus, FRAM 1
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HIV Positive FRAM 1 Participant | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2005 (estimated)
- Study startJan 2005
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Joseph Cofrancesco Jr., M.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00244803
- Sponsor's protocol ID
- 03-07-02-01
- Status last verified
- Aug 2016
- First submitted
- 25 Oct 2005
- Last updated
- 31 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21767228
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Redistribution and Metabolic Change in HIV Infection: Protocol 2 (FRAM Fat 2)
- ClinicalTrials.gov ID
- NCT00244803
- Acronym / sponsor ID
- 03-07-02-01
- Conditions
- Human Immunodeficiency Virus
- Keywords
- Human Immunodeficiency Virus, FRAM 1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jan 2005
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 27 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV Positive FRAM 1 Participant | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- men or women 18-65 years old, previous FRAM 1 participant, HIV positive
Key inclusion criteria (3 listed)
- 18-65 years old
- previous FRAM 1 participant
- HIV positive
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2016.
- Derived from this study: PubMed 21767228Lake 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.
Related trials for Human Immunodeficiency Virus
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Cofrancesco Jr., M.D. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Immunodeficiency Virus, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00244803, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2016.