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Testosterone for HIV-Positive Men With Reduced Serum Testosterone Levels and Abdominal Fat

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Testosterone
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Testosterone, Anthropometry, Obesity, Abdomen

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria Patients may be eligible for this study if they: Are HIV-positive. Have been taking anti-HIV medications for at least 12 weeks before study entry and plan to continue taking them for an additional 24 weeks. Are male and between 18 and 70 years old. Have a measurement of greater than 100 cm around the abdomen. Can report an increase in abdominal size after taking antiretroviral drugs. Have a viral load less than 10,000 copies/ml within 6 weeks prior to screening. Have a serum total testosterone between 125 and 400 ng/dl. If serum total testosterone is greater than 400 ng/dl, bioavailable testosterone must be less than 115 ng/dl or free testosterone must be less than 50 pg/ml. Exclusion Criteria Patients will not be eligible for this study if they: Take certain drugs, including testosterone derivatives, glucocorticoids, appetite stimulants, dronabinol, megestrol acetate, androstenediols, oxandrolone, or other anabolic agents such as dehydroepiandrosterone (DHEA) or growth hormone within 12 weeks prior to study entry. Take hydroxyurea within 30 days of study entry. Take drugs for diabetes. Have diabetes. Take granulocyte-macrophage colony-stimulating factor (GM-CSF). (Granulocyte colony-stimulating factor (G-CSF) is allowed.) Take cytokines, cytokine inhibitors, or ketoconazole. Take ritonavir with simvastatin or lovastatin. Have an active opportunistic infection. Patients on treatment for at least 12 weeks will be allowed. Have 5-7 loose stools per day or diarrhea for more than 1 week, within 6 weeks of study entry. Have a blood pressure greater than 160 over 100. Have certain heart problems. Have a breast mass that has not been diagnosed. Have active cancer. Have had prostate cancer or certain other prostate problems. Are allergic to any part of the testosterone gel. Have a history of blood clots. Have a history of sleep apnea. Are receiving experimental treatment. Are receiving experimental drugs in other studies and do not know if they are taking the drug or placebo. Abuse drugs or alcohol in a way that would interfere with the study. Are dieting or doing heavy exercising. Have a viral load of 10,000 copies/ml or more at screening

Sites / Locations

  • USC CRS
  • Charles R. Drew Univ. of Medicine and Science, Div. of Infectious Diseases
  • Stanford CRS
  • Ucsd, Avrc Crs
  • Ucsf Aids Crs
  • Santa Clara Valley Med. Ctr.
  • San Mateo County AIDS Program
  • Marin County Dept. of Health & Human Services, HIV/AIDS Program & Specialty Clinic
  • University of Colorado Hospital CRS
  • Queens Med. Ctr.
  • Univ. of Hawaii at Manoa, Leahi Hosp.
  • Northwestern University CRS
  • Rush Univ. Med. Ctr. ACTG CRS
  • Indiana Univ. School of Medicine, Infectious Disease Research Clinic
  • Indiana Univ. School of Medicine, Wishard Memorial
  • Methodist Hosp. of Indiana
  • IHV Baltimore Treatment CRS
  • University of Minnesota, ACTU
  • St. Louis ConnectCare, Infectious Diseases Clinic
  • Washington U CRS
  • Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.
  • NY Univ. HIV/AIDS CRS
  • Univ. of Cincinnati CRS
  • Hosp. of the Univ. of Pennsylvania CRS
  • Univ. of Pennsylvania Health System, Presbyterian Med. Ctr.
  • Pitt CRS
  • Puerto Rico-AIDS CRS

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 1, 2001
Last Updated
October 28, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00009555
Brief Title
Testosterone for HIV-Positive Men With Reduced Serum Testosterone Levels and Abdominal Fat
Official Title
A Prospective, Multicenter, Randomized, Placebo-Controlled Trial of Physiologic Testosterone Supplementation for HIV-Positive Men With Mildly to Moderately Reduced Serum Testosterone Levels and Abdominal Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
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 see if treatment with testosterone will reduce abdominal fat in HIV-positive men. Many HIV patients on antiretroviral therapy show an increase in abdominal fat. Studies have shown that treatment with testosterone may decrease abdominal fat. This study will determine if testosterone will reduce abdominal fat in HIV patients.
Detailed Description
Reports suggest that many HIV-infected patients on antiretroviral therapy experience an increase in abdominal fat. The mechanisms of abdominal fat accumulation in HIV-infected patients are not known. Studies have shown: treatment with testosterone gel reduces total body fat in young, androgen-deficient men; testosterone replacement in middle-aged men with mid-segment obesity decreases visceral fat; and replacement doses of testosterone decrease fat mass and augment lean body mass in HIV-infected men with androgen deficiency. Therefore, there is a strong rationale for evaluating the effectiveness of testosterone replacement in HIV-infected men with visceral obesity and low testosterone levels. Patients are stratified based on their viral load. Patients receive either testosterone gel or placebo applied to the skin once daily for 24 weeks. Patients remain on their current antiretroviral regimens, which are not supplied through the study. Patients who receive testosterone during the first 24 weeks are eligible to receive it for an additional 24 weeks. Patients on placebo are followed for an additional 24 weeks. Clinical and laboratory evaluations for visceral fat changes are performed throughout the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Testosterone, Anthropometry, Obesity, Abdomen

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Masking
Double
Enrollment
86 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Testosterone

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Patients may be eligible for this study if they: Are HIV-positive. Have been taking anti-HIV medications for at least 12 weeks before study entry and plan to continue taking them for an additional 24 weeks. Are male and between 18 and 70 years old. Have a measurement of greater than 100 cm around the abdomen. Can report an increase in abdominal size after taking antiretroviral drugs. Have a viral load less than 10,000 copies/ml within 6 weeks prior to screening. Have a serum total testosterone between 125 and 400 ng/dl. If serum total testosterone is greater than 400 ng/dl, bioavailable testosterone must be less than 115 ng/dl or free testosterone must be less than 50 pg/ml. Exclusion Criteria Patients will not be eligible for this study if they: Take certain drugs, including testosterone derivatives, glucocorticoids, appetite stimulants, dronabinol, megestrol acetate, androstenediols, oxandrolone, or other anabolic agents such as dehydroepiandrosterone (DHEA) or growth hormone within 12 weeks prior to study entry. Take hydroxyurea within 30 days of study entry. Take drugs for diabetes. Have diabetes. Take granulocyte-macrophage colony-stimulating factor (GM-CSF). (Granulocyte colony-stimulating factor (G-CSF) is allowed.) Take cytokines, cytokine inhibitors, or ketoconazole. Take ritonavir with simvastatin or lovastatin. Have an active opportunistic infection. Patients on treatment for at least 12 weeks will be allowed. Have 5-7 loose stools per day or diarrhea for more than 1 week, within 6 weeks of study entry. Have a blood pressure greater than 160 over 100. Have certain heart problems. Have a breast mass that has not been diagnosed. Have active cancer. Have had prostate cancer or certain other prostate problems. Are allergic to any part of the testosterone gel. Have a history of blood clots. Have a history of sleep apnea. Are receiving experimental treatment. Are receiving experimental drugs in other studies and do not know if they are taking the drug or placebo. Abuse drugs or alcohol in a way that would interfere with the study. Are dieting or doing heavy exercising. Have a viral load of 10,000 copies/ml or more at screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shalender Bhasin
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Cecilia Shikuma
Official's Role
Study Chair
Facility Information:
Facility Name
USC CRS
City
Los Angeles
State/Province
California
ZIP/Postal Code
900331079
Country
United States
Facility Name
Charles R. Drew Univ. of Medicine and Science, Div. of Infectious Diseases
City
Los Angeles
State/Province
California
ZIP/Postal Code
90059
Country
United States
Facility Name
Stanford CRS
City
Palo Alto
State/Province
California
ZIP/Postal Code
943055107
Country
United States
Facility Name
Ucsd, Avrc Crs
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Ucsf Aids Crs
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Santa Clara Valley Med. Ctr.
City
San Jose
State/Province
California
Country
United States
Facility Name
San Mateo County AIDS Program
City
San Mateo
State/Province
California
Country
United States
Facility Name
Marin County Dept. of Health & Human Services, HIV/AIDS Program & Specialty Clinic
City
San Rafael
State/Province
California
Country
United States
Facility Name
University of Colorado Hospital CRS
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Queens Med. Ctr.
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96816
Country
United States
Facility Name
Univ. of Hawaii at Manoa, Leahi Hosp.
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96816
Country
United States
Facility Name
Northwestern University CRS
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush Univ. Med. Ctr. ACTG CRS
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
462025250
Country
United States
Facility Name
Indiana Univ. School of Medicine, Wishard Memorial
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Methodist Hosp. of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
IHV Baltimore Treatment CRS
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
University of Minnesota, ACTU
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455-0392
Country
United States
Facility Name
St. Louis ConnectCare, Infectious Diseases Clinic
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
Washington U CRS
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.
City
Omaha
State/Province
Nebraska
Country
United States
Facility Name
NY Univ. HIV/AIDS CRS
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Univ. of Cincinnati CRS
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
452670405
Country
United States
Facility Name
Hosp. of the Univ. of Pennsylvania CRS
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Univ. of Pennsylvania Health System, Presbyterian Med. Ctr.
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Pitt CRS
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Puerto Rico-AIDS CRS
City
San Juan
ZIP/Postal Code
009365067
Country
Puerto Rico

12. IPD Sharing Statement

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Testosterone for HIV-Positive Men With Reduced Serum Testosterone Levels and Abdominal Fat

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