Effects of androgen administration in men with the AIDS wasting syndrome. A randomized, double-blind, placebo-controlled trial.
BACKGROUND
Development of successful anabolic strategies to reverse the loss of lean body mass is of critical importance to increase survival in men with the AIDS wasting syndrome. Hypogonadism, an acquired endocrine deficiency state characterized by loss of testosterone, occurs in more than half of all men with advanced HIV disease. It is unknown whether testosterone deficiency contributes to the profound catabolic state and loss of lean body mass associated with the AIDS wasting syndrome.


OBJECTIVE
To investigate the effects of physiologic testosterone administration on body composition, exercise functional capacity, and quality of life in androgen-deficient men with the AIDS wasting syndrome.


METHODS
Randomized, double-blind, placebo-controlled study.


METHODS
University medical center.


METHODS
51 HIV-positive men (age 42 +/- 8 years) with wasting (body weight < 90% of ideal body weight or weight loss > 10% of baseline weight) and a free testosterone level less than 42 pmol/L (normal range for men 18 to 49 years of age, 42 to 121 pmol/L [12.0 to 35.0 pg/mL]).


METHODS
Patients were randomly assigned to receive testosterone enanthate, 300 mg, or placebo intramuscularly every 3 weeks for 6 months.


METHODS
Change in fat-free mass was the primary end point. Secondary clinical end points were weight, lean body mass, muscle mass, exercise functional capacity, and change in perceived quality of life. Virologic variables were assessed by CD4 count and viral load.


RESULTS
Compared with patients who received placebo, testosterone-treated patients gained fat-free mass (-0.6 kg and 2.0 kg; P = 0.036), lean body mass (0.0 kg and 1.9 kg; P = 0.041), and muscle mass (-0.8 kg and 2.4 kg; P = 0.005). The changes in weight, fat mass, total-body water content, and exercise functional capacity did not significantly differ between the groups. Patients who received testosterone reported benefit from the treatment (P = 0.036), feeling better (P = 0.033), improved quality of life (P = 0.040), and improved appearance (P = 0.021). Testosterone was well tolerated in all patients.


CONCLUSIONS
Physiologic testosterone administration increases lean body mass and improves quality of life among androgen-deficient men with the AIDS wasting syndrome.
Grinspoon
S
S
Massachusetts General Hospital, Harvard Medical School, Boston 02114, USA.
Corcoran
C
C
Askari
H
H
Schoenfeld
D
D
Wolf
L
L
Burrows
B
B
Walsh
M
M
Hayden
D
D
Parlman
K
K
Anderson
E
E
Basgoz
N
N
Klibanski
A
A
D000293:Adolescent; D000328:Adult; D001823:Body Composition / Q000187:drug effects; D018791:CD4 Lymphocyte Count; D004311:Double-Blind Method; D005080:Exercise Test; D019247:HIV Wasting Syndrome / Q000097:blood / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009752:Nutritional Status; D010349:Patient Compliance; D017060:Patient Satisfaction; D010919:Placebos; D011788:Quality of Life; D013739:Testosterone / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000172:deficiency / Q000627:therapeutic use; D019562:Viral Load; D015430:Weight Gain / Q000187:drug effects
D010919:Placebos; D013739:Testosterone; C004648:testosterone enanthate