Trial Information

Summary: Testosterone Replacement and Physical Function in HIV-Associated Weight Loss.

Men infected with the HIV virus (the virus that causes AIDS) often lose weight even though they may try to eat more food to gain weight. The reasons for this weight loss are not clear. Many men with HIV have low levels of testosterone in their blood. Testosterone is a hormone that is naturally produced in the bodies of both men and women and has important effects on building muscle and bone mass. The purpose of this study is to find out if providing additional testosterone to HIV infected men who have low testosterone can help them gain weight, increase their muscle mass, and feel better. The study will also help see if testosterone improves the efficiency with which your body produces and uses energy. The dose of testosterone being used in this study will raise testosterone levels in the blood to higher than normal levels (2-3 times normal level).

Inclusion Criteria:

• HIV positive men, 18-60 years of age, with objective evidence of HIV-infection with low to low-normal testosterone levels (< 400 ng/dL). We will exclude men over 60 because of age-related changes in testosterone levels and body composition, and increased risk of prostate disease.
• Documented weight loss within the previous 6 months of between 5-15% of body weight
• An energy intake of at least 80% of the estimated requirements.
• On stable and potent anti-retroviral therapy for at least 12 weeks, or will not be starting anti-retroviral therapy in the next 4 months
• CD4 cell count > 50 /mm3, and HIV-copy number less than 10,000 copies/ml
• Testosterone levels < 400ng/dL
• Able and willing to provide informed consent and comply with the protocol

Exclusion Criteria:

• Concurrent severe lipodystrophy*
• History of prostatic or mammary cancer
• Significant diarrhea
• Use of any androgen, growth hormone, or other anabolic or orexigenic agents within the past 6 months or steroid
• Significant cardiac, renal, hepatic or other diseases
• AIDS defining illness (CDC HIV Classification, 1993: Clinical Category C) within the previous 3 months (except HIV wasting syndrome)
• Malignancy, other than Kaposi’s Sarcoma localized to the skin
• Involvement in (vigorous) resistance exercise training programs (body building) in the past 3 months
• Diabetes mellitus
• Limiting neuromuscular, joint or bone disease, or history of stroke with residual neurological defect that would preclude measurements of muscle strength or physical function
• Prostate specific antigen (PSA) > 4 and normal range for AUA test
• Untreated severe obstructive sleep apnea
• Current alcohol or drug dependence which would interfere with compliance for the study
• Subject receive investigational treatment except stable antiretroviral investigational drug in the last 12 weeks
• Subject have a history of hypersensitivity to anabolic steroids or to growth hormone
• Any of the following blood test results:
  • Liver function test (ALT, AST) ³ 5x the upper limit of the normal range (ULN)
  • Alkaline Phosphotase > 5x ULN or > 3x ULN if bilirubin is above normal
  • Cholesterol total (> 5 x ULN) or triglycerides ³ 700 mg/dL
  • Serum Creatinine ³ 2x ULN
  • Hemoglobin £8.0 g/dl or > 18 g/dL
  • Platelet count < 50x109/L
  • HCT > 48%
  • PSA ³ 4 ng/ml.

If you would like to learn more about participating in this study, please send an e-mail message using the form below.