NCT00006290

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2000

Completed
11 months until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

September 25, 2008

Status Verified

June 1, 2003

First QC Date

September 21, 2000

Last Update Submit

September 24, 2008

Conditions

Keywords

Drug Therapy, CombinationQuestionnairesQuality of LifePatient ComplianceBody CompositionAnti-HIV AgentsAdipose TissueBody Image

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Univ of California, San Diego

San Diego, California, 92103, United States

Location

Johns Hopkins Hosp

Baltimore, Maryland, 21287, United States

Location

Ohio State Univ Hosp Clinic

Columbus, Ohio, 432101228, United States

Location

Univ of Pennsylvania at Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

HIV InfectionsLipodystrophyPatient Compliance

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSkin Diseases, MetabolicSkin DiseasesSkin and Connective Tissue DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Judith Neidig

    STUDY CHAIR
  • William Holmes

    STUDY CHAIR

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

September 21, 2000

First Posted

August 31, 2001

Last Updated

September 25, 2008

Record last verified: 2003-06

Locations