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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.
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.
Masking: Double-Blind, Primary Purpose: Treatment
Univ of Southern California / LA County USC Med Ctr
National Institute of Allergy and Infectious Diseases (NIAID)
Published on BioPortfolio: 2014-08-27T03:57:10-0400
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Steroidal compounds related to TESTOSTERONE, the major mammalian male sex hormone. Testosterone congeners include important testosterone precursors in the biosynthetic pathways, metabolites, derivatives, and synthetic steroids with androgenic activities.
A potent androgenic metabolite of TESTOSTERONE. Dihydrotestosterone (DHT) is generated by a 5-alpha reduction of testosterone. Unlike testosterone, DHT cannot be aromatized to ESTRADIOL therefore DHT is considered a pure androgenic steroid.
A potent androgenic steroid and major product secreted by the LEYDIG CELLS of the TESTIS. Its production is stimulated by LUTEINIZING HORMONE from the PITUITARY GLAND. In turn, testosterone exerts feedback control of the pituitary LH and FSH secretion. Depending on the tissues, testosterone can be further converted to DIHYDROTESTOSTERONE or ESTRADIOL.
An ester of TESTOSTERONE with a propionate substitution at the 17-beta position.
Inflammation of brain parenchymal tissue as a result of viral infection. Encephalitis may occur as primary or secondary manifestation of TOGAVIRIDAE INFECTIONS; HERPESVIRIDAE INFECTIONS; ADENOVIRIDAE INFECTIONS; FLAVIVIRIDAE INFECTIONS; BUNYAVIRIDAE INFECTIONS; PICORNAVIRIDAE INFECTIONS; PARAMYXOVIRIDAE INFECTIONS; ORTHOMYXOVIRIDAE INFECTIONS; RETROVIRIDAE INFECTIONS; and ARENAVIRIDAE INFECTIONS.
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Human Immuno Deficiency Virus (HIV)
Human Immunodeficiency Virus (HIV), the causative agent of AIDS. The Human Immunodeficiency Virus, more commonly known as HIV, is a member of the lentivirus sub-set of the retrovirus family of pathogens. It causes AIDS, or Acquired Immuno Deficiency Sy...