OBJECTIVE: In patients with human immunodeficiency virus, body weight (BW) loss, due mainly to loss of fat-free mass, is associated with progression of disease and mortality. Recombinant human growth hormone (rhGH) may promote BW gain by restoring FFM. METHODS: We investigated the results of adding to highly active antiretroviral therapy of routine rhGH treatment in 34 patients with human immunodeficiency virus who had lost 5% to 20% of their usual BWs. They were recruited by their physicians in Switzerland and were instructed to self-administer the drug. Patients were given 6 mg of rhGH each day for 12 wk. BW and body composition, measured by bioelectrical impedance analysis (50 kHz, tetrapolar), were recorded at baseline and at 4, 8, and 12 wk of treatment. RESULTS: At week 12, BW gain averaged 3.0 +/- 0.5 kg (P < 0.001), fat-free mass gain was 4.8 +/- 0.5 kg (P = 0.001), and body fat mass loss was 1.8 +/- 0.4 kg (P = 0.008). BW and fat-free mass increases and FM decrease were evident by week 4 and tended to plateau by week 8. Therapy was well tolerated; one patient developed carpal tunnel syndrome. Five patients abandoned the study for reasons unrelated to the rhGH treatment. CONCLUSION: Our data strongly support the use of rhGH in the treatment of unintentional BW loss associated with human immunodeficiency virus. The low rate of dropouts and the low incidence of side effects make the use of rhGH suitable for primary care management.