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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00009555
First received: February 1, 2001
Last updated: May 17, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Testosterone
Phase 4

Study Type: Interventional
Study Design: Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 86
Study Completion Date: March 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00009555

  Show 27 Study Locations
Sponsors and Collaborators
Investigators
Study Chair: Shalender Bhasin
Study Chair: Cecilia Shikuma
  More Information

Additional Information:
No publications provided

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00009555     History of Changes
Other Study ID Numbers: A5079, 10175, ACTG A5079, AACTG A5079
Study First Received: February 1, 2001
Last Updated: May 17, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Testosterone
Anthropometry
Obesity
Abdomen

Additional relevant MeSH terms:
HIV Seropositivity
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on September 16, 2014