NCT00006290

Completed

Perceived Changes in Body Build and Image in Patients Who Ar...

National Institute of Allergy and Infectious Diseases (NIAID)Source

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Other study identifiers

Sponsor study identifier

ACTG A5089

Secondary identifiers

AACTG A5089

Study Type

observational

Reported enrollment (type unavailable)

60

Locations

1 country

Sites

4

Timeline

Study Start

Not reported

Date not reported

Primary Completion

Not reported

Date not reported

Study Completion

Not reported

Date not reported

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Reported enrollment (type unavailable): 60 participants
Study completion date: Not reported
Date not reported
Listed locations: 1 countries · 4 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
September 21, 2000
Actual (reported)
First Posted
August 31, 2001
Actual (reported)

Last Updated: September 25, 2008
Status Verified: June 2003
Last Update Submitted: September 24, 2008

Conditions

HIV Infections Lipodystrophy

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.

Sponsors & Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)
NIHlead

Study Sites (4)

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

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 Syndromes

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

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00006290
Data provider: ClinicalTrials.gov
Source updated: 2008-09-25
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:34:04 UTC

Locations

NCT00006190

A Study to Determine How and Why HIV-Infected Subjects on Anti-viral Treatment Develop Lipodystrophy

Phase 4Completed

NCT00426296

SHARE: Simple HAART With Abacavir, Reyataz, and Epivir

Phase 4Unknown

NCT00461552

Therapeutic Approaches to HAART-Induced Lipodystrophy

Phase 2Completed

NCT00656175

Raltegravir Therapy for Women With HIV and Fat Accumulation

Phase 2Completed

NCT00123253

TH9507 in Patients With HIV-Associated Lipodystrophy

Phase 3Completed

NCT00082628

Treatment of Abnormal Adipose Tissue Accumulation in Human Immunodeficiency Virus (HIV) Patients

Phase 3Completed

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.

Immune System Diseases

Skin Diseases, Metabolic

Skin Diseases

Skin and Connective Tissue Diseases

Lipid Metabolism Disorders

Metabolic Diseases

Nutritional and Metabolic Diseases

Patient Acceptance of Health Care

Treatment Adherence and Compliance

Health Behavior

Behavior

US

(4)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Conditions

Keywords

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Source record

Locations

You may not qualify if: