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Hypogonadism & Androgen Replacement in HIV-Positive Men. By Jabari Capp. HIV & Hypogonadism. 25-60% of HIV-Positive Men Have Serum Testosterone Levels Low Enough To Be Considered Hypogonadal.
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Hypogonadism & Androgen Replacement in HIV-Positive Men By Jabari Capp
HIV & Hypogonadism • 25-60% of HIV-Positive Men Have Serum Testosterone Levels Low Enough To Be Considered Hypogonadal. • Decreased Testosterone Levels Strongly Contribute To The Exacerbation of the Disease & the Loss of Lean Muscle Mass & Normal Muscle Function, Characteristic of AIDS Wasting Syndrome (AWS).
Use of Androgen Therapy • The Use of Testosterone Replacement in Hypogonadal Men & Castrated Male Animals Has Been Well Documented To Increased Fat-Free Mass, Muscle Size, Strength.
Purpose of Study • The Major Purpose of This Study Was To Determine If Testosterone Replacement Positively Affected The Overall Health of Hypogonadal, HIV-Positive Men. • The Primary Means of Measuring The Efficacy of the Use of Testosterone Replacement is by Assessing the Gains of Lean Body Mass.
The Subjects • The Study Recruited Hypogonadal, HIV-Positive Men Between the Ages of 18 & 60 Years Who Were Ambulatory & in Otherwise Good Health. • The Patients Were Randomly & Blindly Divided Into Either a Testosterone- Treatment Group or a Placebo Group. • Most of the Patients in Both of the Groups Received Anti-Retroviral Therapy Throughout the Study.
The Protocol • Over a 12-Week Treatment Period, the Patients Were Required to Apply Either 2 Testosterone Patches or 2 Placebo Patches, Depending on the Group, on the Skin of the Abdomen, Back, Arms, or Thighs Every Night for 12 Months. • All of the Patients who Completed the Study Used More Than 75% of Their Allotted Patches, While 88% Used More Than 90% of the Patches.
Effects on Lean Body Mass • Placebo Group • 50.072 ± 1.514 kg 50.700 ± 1.669 kg • Δ = 0.189 ± 0.470 kg • Testosterone Treatment Group • 51.264 ± 1.694 kg 53.408 ± 1.992 kg • Δ = 1.345 ± 0.533 kg
Effects on Fat-Free Mass • Placebo Group • 52.543 ± 1.556 kg 53.137 ± 1.731 kg • Δ = 0.186 ± 0.470 kg • Testosterone Treatment Group • 53.832 ± 1.748 kg 56.034 ± 2.041 kg • Δ = 1.364 ± 0.525 kg
Changes in Fat Mass • Placebo Group • Δ = 0.880 ± 0.520 kg • Testosterone Treatment Group • Δ = -0.569 ± 0.573 kg
Changes in Testosterone Levels • Total Testosterone: • Placebo Group- 222 ± 22 ng/dL • Δ = 10 ±16 ng/dL Testosterone Group- 367 ± 35 ng/dL Δ = 100 ± 39 ng/dL
Changes in RBC & Hemoglobin • Placebo Group: • Mean RBC- Δ = -0.2 ± 0.1 X 1012/L • Hemoglobin- Δ = -4.5 ± 4.8 g/L • Testosterone Treatment Group • Mean RBC- Δ = 0.1 ± 0.1 X 1012/L • Hemoglobin- Δ = 2.9 ± 2.9 g/L
Changes in T-Cells • Placebo Group: • CD4+ T-Cells- Δ = -26 ± 17 cells/cm • CD8+ T-Cells- Δ = 13 ± 47 cells/cm • Testosterone Treatment Group: • CD4+ T-Cells- Δ = -28 ± 13 cells/cm • CD8+ T-Cells- Δ = -69 ± 52 cells/cm
Changes in Plasma HIV RNA Copies • Placebo Group: • Δ = -3.9 ± 3.7 X 105 Copies/mL • Testosterone Treatment Group: • Δ = -1.6 ± 0.9 X 105 Copies/mL
Changes in Prostate-Specific Antigen (PSA) & Cholesterol • Placebo Group: • Δ = -0.01 ± 0.24 ng/mL • Testosterone Treatment Group: • Δ = 0.05 ± 0.04 ng/mL • NO CHANGE IN TOTAL CHOLESTEROL, HDL, OR LDL IN BOTH GROUPS.