NCT00027092

Brief Summary

The purpose of this study is to find out if testosterone gel affects how the body handles insulin and glucose. Specific anti-HIV treatments may increase a patient's risk of certain diseases by causing metabolic problems such as reduced sensitivity to insulin. This substudy will examine how testosterone affects insulin sensitivity. If testosterone increases insulin sensitivity in the patients, then giving testosterone to HIV-infected patients may allow the continuation of anti-HIV treatments without increasing the patients' risk of disease. The test used to determine insulin sensitivity will be a modified frequently sampled intravenous glucose tolerance test (FSIVGTT), which can accurately measure insulin sensitivity.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

8 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

November 20, 2001

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 21, 2001

Completed
Last Updated

August 7, 2008

Status Verified

February 1, 2004

First QC Date

November 20, 2001

Last Update Submit

August 6, 2008

Conditions

Keywords

Infusions, IntravenousTestosteroneInsulin ResistanceHormone Replacement TherapyGlucose Tolerance Test

Eligibility Criteria

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

You may qualify if:

  • Patients may be eligible for this study if they:
  • Are enrolled in A5079.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Univ of Southern California / LA County USC Med Ctr

Los Angeles, California, 900331079, United States

Location

Univ of California San Francisco

San Francisco, California, 94110, United States

Location

Univ of Hawaii

Honolulu, Hawaii, 96816, United States

Location

Rush Presbyterian - Saint Luke's Med Ctr

Chicago, Illinois, 60612, United States

Location

Indiana Univ Hosp

Indianapolis, Indiana, 462025250, United States

Location

Methodist Hosp of Indiana / Life Care Clinic

Indianapolis, Indiana, 46202, United States

Location

Wishard Hosp

Indianapolis, Indiana, 46202, United States

Location

Bellevue Hosp / New York Univ Med Ctr

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

HIV InfectionsInsulin Resistance

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Shalender Bhasin

    STUDY CHAIR

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 20, 2001

First Posted

November 21, 2001

Last Updated

August 7, 2008

Record last verified: 2004-02

Locations