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

Primary Purpose

HIV Infections, Lipodystrophy

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for HIV Infections focused on measuring Drug Therapy, Combination, Questionnaires, Quality of Life, Patient Compliance, Body Composition, Anti-HIV Agents, Adipose Tissue, Body Image

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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.

Sites / Locations

  • Univ of California, San Diego
  • Johns Hopkins Hosp
  • Ohio State Univ Hosp Clinic
  • Univ of Pennsylvania at Philadelphia

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 21, 2000
Last Updated
September 24, 2008
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00006290
Brief Title
Perceived Changes in Body Build and Image in Patients Who Are Now Taking or Recently Have Stopped Taking Anti-HIV Drugs
Official Title
Perceived Changes in Body Habitus and Body Image Among HIV+ Persons Currently Receiving or Recently Discontinuing Combination Antiretroviral Therapy
Study Type
Observational

2. Study Status

Record Verification Date
June 2003
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Lipodystrophy
Keywords
Drug Therapy, Combination, Questionnaires, Quality of Life, Patient Compliance, Body Composition, Anti-HIV Agents, Adipose Tissue, Body Image

7. Study Design

Enrollment
60 (false)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith Neidig
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
William Holmes
Official's Role
Study Chair
Facility Information:
Facility Name
Univ of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Johns Hopkins Hosp
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Ohio State Univ Hosp Clinic
City
Columbus
State/Province
Ohio
ZIP/Postal Code
432101228
Country
United States
Facility Name
Univ of Pennsylvania at Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

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

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