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CompletedNCT00006290Updated Sep 25, 2008

Perceived Changes in Body Build and Image in Patients Who Are Now Taking or Recently Have Stopped Taking Anti-HIV Drugs

An observational study in HIV Infections and Lipodystrophy, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-09-25.

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Observational

Study type
Observational
Enrollment
60
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to learn how changes in body build affect the lives of people taking anti-HIV medications. By learning this, a set of questions can be created to help understand how changes in body build and image affect people living with HIV infection.

A set of questions used to measure body image might be useful in future HIV studies. It may help doctors understand patient concerns about their body image and why some patients stop taking their anti-HIV medications.

Read the detailed description

A valid measure of body image would be useful for AACTG studies. Such a measure might permit investigators to examine dissatisfaction with body image as a predictor variable in analyses of premature study drug discontinuation, loss to follow-up, and study drug non-adherence, and as a secondary outcome in antiretroviral and fat redistribution treatment trials.

Six focus group interviews, each lasting approximately 2 hours, are conducted at 4 AACTG sites. Separate groups are run for men and women, and male groups are segmented by sexual orientation. A moderator leads discussions about patients' perceived changes in body habitus and body image. Group interviews are audio-taped and transcribed verbatim. Qualitative interview data are sent electronically to the Data Management Center, where they are thematically analyzed using qualitative data analysis (content analysis) techniques. Salient focus group findings are used to construct questionnaire items.

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Conditions studied

  • HIV Infections
  • Lipodystrophy

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Keywords

  • Drug Therapy, Combination
  • Questionnaires
  • Quality of Life
  • Patient Compliance
  • Body Composition
  • Anti-HIV Agents
  • Adipose Tissue
  • Body Image
03

In context

Lipodystrophy

163 studies on the registry are indexed under Lipodystrophy; 11 are open to participants now.

This study's enrollment of 60 is below the median of 100 across 35 observational studies indexed under Lipodystrophy.

Browse Lipodystrophy studies →

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,401 studies on the registry; 179 are open to participants now.

Of its 396 completed or terminated interventional studies of FDA-regulated products, 294 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Patients may be eligible for this study if they:

  • Are 18 years or older.
  • Are HIV-positive.
  • Are experiencing at least 1 of the following symptoms associated with fat changes due to HIV: 1) increase in belt or waist size; 2) increase in size of back of neck; 3) increase in bra, shirt, or blouse size to fit increasing breast size; 4) fat increase in other areas of the body; 5) loss of facial fat; 6) loss of fat in arms or legs; 7) loss of fat in buttocks.
  • Agree to protect the confidentiality of other focus group participants.
  • Are able to speak and read English.
  • Have taken 2 or more anti-HIV medications for a total of at least 6 months at any time before entering this study. Patients must have taken some anti-HIV treatment during the 6-month period before study entry. Patients who have stopped taking these medications in the 6 months before study entry may still be eligible.
  • Are willing to talk about personal topics in a taped group interview.
  • Are male and either gay or bisexual (if enrolling in the Ohio State University or University of California focus groups).
  • Are either female or heterosexual male (if enrolling in the University of Pennsylvania or Johns Hopkins University focus groups).

Exclusion criteria

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Have a mental disability that, in the opinion of the researcher, could interfere with study participation.
  • Have already taken part in an A5089 focus group interview.
  • Have diabetes or Cushing's disease or have had surgery that might otherwise explain changes in body fat.
  • Have changes in diet or physical activity that might explain changes in body fat.
  • Have been on glucocorticoid therapy for a long time.
  • Are pregnant.
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Study design

Enrollment
60 participants
06

Study locations

4 sites
  • Univ of California, San Diego
    San Diego, California 92103, United States
  • Johns Hopkins Hosp
    Baltimore, Maryland 21287, United States
  • Ohio State Univ Hosp Clinic
    Columbus, Ohio 432101228, United States
  • Univ of Pennsylvania at Philadelphia
    Philadelphia, Pennsylvania 19104, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 25, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00006290
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
First posted
Aug 31, 2001
Last update
Sep 25, 2008

Study contacts

Judith Neidig
study chair
William Holmes
study chair
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2003. You cannot join it, but the record below documents what was studied.

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