CATIE IMMUNOMODULATORS: Growth hormone for weight loss: a 3-month study

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IMMUNOMODULATORS: Growth hormone for weight loss: a 3-month study

Canadian AIDS Treatment Information Exchange (CATIE) TreatmentUpdate48, Vol. 4, No. 8 - March 1994
Sean Hosein


STUDY DETAILS

Researchers in Albuquerque, New Mexico, have also been conducting experiments on 10 subjects with HIV infection to find out the effects of supplemental growth hormone. In the past, 4 subjects had bouts of PCP, 2 had Kaposi's sarcoma and eight had nerve damage. Seven subjects were using AZT. All subjects had lost at least 10% of their body weight. In 5 subjects weight loss averaged 2.3 kg/6 weeks. The researchers selected the subjects at random and gave each either 5 or 2.5 mg of GH injected under the skin "every other day for 12 weeks." Thus every subject received GH. The researchers stated that a placebo- controlled study would not have been ethical and because of pressure from community-based AIDS groups, they could not perform a placebo- controlled study.

RESULTS-WEIGHT AND PROTEIN

Before starting on GH, subjects had been continuously losing weight. In some subjects who received the 5 mg dose of GH, their weight stabilized and some even gained weight. This weight stabilization and/or increase in weight was statistically significant, that is, not likely due to chance alone. As well, subjects gained weight because of increased muscle tissue and at the same time lost fat. After 12 weeks of receiving GH, subjects gained an average of nearly 4 kg in muscle tissue. These increases in muscle tissue and loss of fat were statistically significant. Nitrogen is an element the body uses to make protein. During the study Where was a trend to urinate less nitrogen. This trend is important and may explain part of the muscle increase.

RESULTS-`MUSCLE POWER AND ENDURANCE'

There was an increase in 'muscle power and endurance' in subjects receiving the 5 mg dose. This happened by the sixth week of the study and continued while subjects received GH.

RESULTS - CD4+ CELLS

The researchers excluded three subjects from the study because they became ill with PCP and MAC. Data from these subjects up until they became ill were used in the statistical analysis. These three subjects had CD4+ cell counts ranging from 10 to 16 cells. In the seven remaining subjects there was no significant change in CD4+ cell counts.

RESULTS BETA2-MICROGLOBULIN

Beta2-m is a protein produced by the immune system. As the ability of the immune system to contain infections decreases, blood levels of Beta2-m increase. All in all, blood levels of Beta2-m fell during the study.

SIDE EFFECTS

Five subjects had increased appetite during the study. No subject had any detectable toxicity due to injections of GH. Subjects did not 'grow' because of the injections of GH.

SUMMARY

In this study, injections of GH caused subjects to gain weight, especially muscle tissue, and there was a trend to increasing 'muscle power and endurance' in the 5 mg dose group. The increase in muscle and decrease in fat is not surprising because these effects happen in other humans given GH. Questions remain as to the best dose and schedule of GH therapy in subjects with HIV/AIDS. Subjects resumed losing weight when the doctors stopped giving them GH. GH appears to have short-term benefits. Larger trials are planned in the USA. The GH used in these experiments is Nutropin, made by Genentech, South San Francisco, CA., 1-800-821-8590.

REFERENCES:

1. Krentz AJ, Koster FT, Christ DM, et al. Anthropometric, metabolic and immunological effects of recombinant human growth hormone in AIDS and AIDS-related complex. Journal of Acquired Immunodeficiency Syndromes 1993;6:245-251.

2. Veldhuis JD, Johnson ML, Faunt LM, et al. Influence of the high-affinity growth hormone (GH)-binding protein on plasma profiles of free and bound GH and on the half-life of GH. Journal of Clinical Investigation 1993;91:629-644.

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