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Recombinant Human Growth Hormone, Insulin-like Growth Factor 1, and Combination Therapy in AIDS-Associated Wasting: A Randomized, Double-Blind, Placebo-Controlled Trial

Debra Waters, PhD; Jeff Danska, PA-C; Kevin Hardy, MD; Frederick Koster, MD; Clifford Qualls, PhD; Donna Nickell*, RD; Stephen Nightingale, MD; Neil Gesundheit, MD; Durwood Watson, PA-C; and David Schade, MD
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Copyright ©2004 by the American College of Physicians


Ann Intern Med. 1996;125(11):865-872. doi:10.7326/0003-4819-125-11-199612010-00001
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Objective: To increase lean body mass and improve health status in patients with wasting associated with the acquired immunodeficiency syndrome (AIDS) by treatment with recombinant human growth hormone (rhGH), recombinant human insulin-like growth factor 1 (rhIGF-1), or both.

Design: Randomized, double-blind, placebo-controlled clinical trial.

Setting: University of New Mexico Clinical Research Center and University of Texas Southwestern Medical Center.

Patients: 60 patients with AIDS and wasting as defined by the Centers for Disease Control and Prevention. Patients were divided into four groups of 15 patients each.

Intervention: Group 1 received 1.4 mg of rhGH once daily plus placebo twice daily; group 2 received 5 mg of rhIGF-1 twice daily plus placebo once daily; group 3 received 5 mg of rhIGF-1 twice daily plus 1.4 mg of rhGH once daily; and group 4 received placebo three times daily.

Measurements: Body weight, body composition, muscle strength, protein catabolism, quality of life, and immune status were assessed at baseline, and changes in these variables were measured at 6 and 12 weeks.

Results: At 6 weeks, lean body mass had increased and total fat mass had decreased in the groups receiving rhGH, rhIGF-1, or both. Group 3 had the greatest changes in lean body mass (mean ± SE, 3.2 ± 0.59 kg; P < 0.001); only in this group were changes in body mass maintained at 12 weeks. Only patients in group 1 had improvement in muscular strength of the knees and upper body (P = 0.04) and quality of life (P = 0.01). Immunologic function did not improve in any group.

Conclusions: Growth factor therapy had significantly increased lean body mass and decreased fat mass by 6 weeks, but these improvements persisted for 12 weeks only in group 3. Growth factor therapy at the dosages used in this study is not recommended because the magnitude of weight gain was modest and improvements in quality-of-life measures varied.

Deceased.

Figures

Grahic Jump Location
Figure 1. Values are the mean changes and 95% Cls. * = significant differences compared with baseline ( < 0.01). The following are the numbers of patients in each treatment group at weeks 6 and 12: recombinant human growth hormone plus insulin-like growth factor 1 (rhGH + rhIGF-1), 13 and 9, respectively; rhGH, 12 and 11, respectively; IGF-1, 1D and 4, respectively; placebo, 14 and 11, respectively.
Changes in body weight, lean body mass, and fat mass 6 and 12 weeks after therapy.P
Grahic Jump Location
Grahic Jump Location
Figure 2. Values are the mean changes and 95% Cls. * = significant differences compared with baseline ( < 0.05). The following are the numbers of patients in each treatment group at weeks 6 and 12: recombinant human growth hormone plus insulin-like growth factor 1 (rhGH + rhIGF-1), 13 and 9, respectively; rhGH, 12 and 11, respectively; rhIGF-1, 10 and 4, respectively; placebo, 14 and 11, respectively.
Change in total quality-of-life scores 6 and 12 weeks after therapy.P
Grahic Jump Location

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