Testosterone for HIV-Positive Men With Reduced Serum Testosterone Levels and Abdominal Fat
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Testosterone (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID) Official(s) and/or principal investigator(s):
Shalender Bhasin, Study Chair
Cecilia Shikuma, Study Chair
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.
Clinical Details
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 design: Treatment, Double-Blind
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
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Male.
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
Locations and Contacts
Univ of Puerto Rico, San Juan 009365067, Puerto Rico
Stanford Univ Med Ctr, Stanford, California 943055107, United States
Univ of Southern California / LA County USC Med Ctr, Los Angeles, California 900331079, United States
San Mateo AIDS Program / Stanford Univ, Stanford, California 943055107, United States
Willow Clinic, Menlo Park, California 94025, United States
Univ of California San Francisco, San Francisco, California 94110, United States
Univ of California, San Diego, San Diego, California 92103, United States
Charles Drew Medical Center, Los Angeles, California 90059, United States
Univ of Colorado Health Sciences Ctr, Denver, Colorado 80262, United States
Queens Med Ctr, Honolulu, Hawaii 96816, United States
Univ of Hawaii, Honolulu, Hawaii 96816, United States
Northwestern Univ Med School, Chicago, Illinois 60611, United States
Rush Presbyterian - Saint Luke's Med Ctr, Chicago, Illinois 60612, United States
Indiana Univ Hosp, Indianapolis, Indiana 462025250, United States
Methodist Hosp of Indiana / Life Care Clinic, Indianapolis, Indiana 46202, United States
Wishard Hosp, Indianapolis, Indiana 46202, United States
University of Maryland, Institute of Human Virology, Baltimore, Maryland 21201, United States
Univ of Minnesota, Minneapolis, Minnesota 55455-0392, United States
Washington Univ School of Medicine, St Louis, Missouri 63108, United States
Washington Univ / St Louis Connect Care, Saint Louis, Missouri 63108, United States
Univ of Nebraska Med Ctr, Omaha, Nebraska, United States
Bellevue Hosp / New York Univ Med Ctr, New York, New York 10016, United States
Univ of Cincinnati, Cincinnati, Ohio 452670405, United States
Univ of Pittsburgh, Pittsburgh, Pennsylvania 15213, United States
Univ of Pennsylvania, Philadelphia, Pennsylvania 19104, United States
Additional Information
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Last updated: August 3, 2006
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