Drugs

Somatropin

Somatropin

Other Names: Genotropin, Humatrope, Nutropin AQ NuSpin, Nutropin AQ Pen, Omnitrope, Saizen, Serostim, Zomacton, Zorbtive, r-hGH, recombinant hGH, recombinant human GH, recombinant human growth hormone, somatotropin Drug Class: Immune Modulators Molecular Formula: C990H1528 N262 O300 S7 Registry Number: 12629-01-5 (CAS) Chemical Name: Growth hormone (human) Chemical Class: Carboxylic acids and derivatives Phase of Development: Somatropin is in Phase II development as an immune modulator for the treatment of HIV infection. (Somatropin is FDA-approved for the treatment of HIV-associated wasting or cachexia.)

(Compound details obtained from ChemIDplus Advanced,1 Clinical and Experimental Immunology article,2 DrugBank website,3 ClinicalTrials.gov,4 and Serostim Full Prescribing Information5)

What is somatropin?

What is somatropin?

Somatropin is being investigated (studied) to treat HIV infection. As an HIV investigational drug, somatropin is categorized as an immune modulator.2 Immune modulators (also called immunomodulators) are substances that help to activate, boost, or restore normal immune function.

Somatropin is currently approved by the U.S. Food and Drug Administration (FDA) for various uses, though it is mainly used to treat growth disorders in children and growth hormone deficiency in adults.3,6,7 Somatropin is FDA-approved to treat HIV-associated wasting or cachexia in people with HIV. Off label use of somatropin may include treatment of HIV-associated lipodystrophy syndrome.5,8

Researchers are studying whether somatropin in combination with antiretroviral therapy (ART) can help reduce the latent HIV reservoir.2,4

To learn how investigational drugs are tested during clinical trials, read the AIDSinfo What is an Investigational HIV Drug? and HIV/AIDS Clinical Trials fact sheets.

Which clinical trials are studying somatropin?

Which clinical trials are studying somatropin?

Study Names: ACTG A5198s; ACTG A5174; NCT00050921
Phase: Not available
Status: This study has been completed.
Location: United States
Purpose: The purpose of this study was to evaluate whether somatropin could increase low CD4 counts in people with HIV who were on ART.9

Study Name: NCT03091374
Phase: II
Status: This study is currently recruiting participants.
Location: Canada
Purpose: The purpose of this study is to evaluate whether somatropin can reduce the latent HIV reservoir in people with HIV on ART with viral suppression.4

Study Name: NCT00071240
Phase: II
Status: This study has been completed.
Location: United States
Purpose: The purpose of this study was to evaluate whether somatropin could increase the size and function of the thymus and increase low CD4 cell counts in people with HIV on ART with viral suppression.10

Study Names: VIHCREC01; NCT00287677
Phase: IV
Status: This study has been completed.
Location: Spain
Purpose: The purpose of this study was to evaluate whether somatropin could boost immune responses to three commonly used vaccines in people with HIV on ART with viral suppression.11

For more details on the studies listed above, see the Health Professional version of this drug summary.

The following clinical trials have also evaluated somatropin as an immune modulator:

  • NCT00119769: A Phase IV substudy that evaluated the effect of somatropin on immune function in people with HIV on ART.2,12
  • NCT01130376: A Phase I study that explored whether an investigational therapeutic HIV vaccine called GTU-MultiHIV B boosted with somatropin and other immune modulators could improve immune responses in people with HIV on ART with viral suppression.13,14

What side effects might somatropin cause?

What side effects might somatropin cause?

One goal of HIV research is to identify new drugs that have fewer side effects. The following side effects were observed in some of the studies of somatropin listed above.

ACTG A5174 (NCT00050921):

Among the 60 participants in this study, eight dropped out because of a side effect. In six participants, carpal tunnel syndrome that was either suspected or diagnosed was likely related to somatropin. One participant entered the study with anal cancer, which worsened during the study, possibly because of somatropin.9,15

NCT00071240:

In this study, three participants stopped taking somatropin and dropped out of the study because of a side effect (diabetes in two participants and carpal tunnel syndrome in one participant). In seven other participants, the somatropin dose was temporarily withheld or reduced by at least half because of side effects.16

Overall, most of the study participants reported having a side effect that was considered at least moderately severe. Most of the side effects were known effects of somatropin treatment and included joint pain, abnormal glucose metabolism, swelling, and carpal tunnel syndrome. There were three reported cases of lymphoma, but only one occurred in a participant who had received somatropin. Three cases of hand tenosynovitis (inflammation of a tendon and the membrane surrounding the tendon) were reported in participants receiving somatropin.16

VIHCREC01 (NCT00287677):

During this study, four participants had their somatropin dose reduced because of a side effect, including joint or muscle pain, swelling of the arms or legs, and nerve damage. In some participants, the somatropin dose had to be reduced at least twice to manage the side effect.11,17

Reported side effects in study participants who received somatropin included joint pain, swelling of the hand, muscle pain, nerve damage, carpal tunnel syndrome, weakness, and acute respiratory infection. Although the side effects were generally mild, somatropin treatment was stopped because of carpal tunnel syndrome in one participant and swelling of the hand in another participant. One participant was hospitalized because of acute respiratory infection.17

Additional side effects known to be associated with somatropin are described in the FDA-approved Full Prescribing Information for Serostim.

Because somatropin is still being studied, information on possible side effects of the drug is not complete. As testing of somatropin continues, additional information on possible side effects will be gathered.

Where can I get more information about clinical trials studying somatropin?

Where can I get more information about clinical trials studying somatropin?

More information about somatropin-related research studies is available from the AIDSinfo database of ClinicalTrials.gov study summaries. Click on the title of any trial in the list to see the ClinicalTrials.gov trial summary and more information about the study.

Some clinical trials may be looking for volunteer participants. Your health care provider can help you decide whether participating in a clinical trial is right for you. For information, visit NIH Clinical Research Trials and You.

References

References

  1. United States National Library of Medicine. ChemIDplus Advanced: Somatropin. https://chem.nlm.nih.gov/chemidplus/rn/12629-01-5. Accessed April 24, 2019.
  2. Herasimtschuk AA, Hansen BR, Langkilde A, Moyle GJ, Andersen O, Imami N. Low-dose growth hormone for 40 weeks induces HIV-1-specific T cell responses in patients on effective combination anti-retroviral therapy. Clin Exp Immunol. 2013;173(3):444-453. doi:10.1111/cei.12141
  3. DrugBank. Somatotropin. https://www.drugbank.ca/drugs/DB00052. Accessed April 24, 2019.
  4. McGill University Health Center. A proof-of-concept study to assess the effect of recombinant human growth hormone on the size of the replication-competent viral reservoir in HIV-infected individuals on suppressive antiretroviral therapy. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on March 21, 2017. NLM Identifier: NCT03091374. https://clinicaltrials.gov/ct2/show/NCT03091374. Accessed April 24, 2019.
  5. EMD Serono, Inc. Serostim: full prescribing information, May 2018. DailyMed. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=62b01d29-90f0-45b2-a0c4-3a750ba36c8a. Accessed April 24, 2019.
  6. Reh CS, Geffner ME. Somatotropin in the treatment of growth hormone deficiency and Turner syndrome in pediatric patients: a review. Clin Pharmacol. 2010;2:111-122.
  7. Cai Y, Xu M, Yuan M, Liu Z, Yuan W. Developments in human growth hormone preparations: sustained-release, prolonged half-life, novel injection devices, and alternative delivery routes. Int J Nanomedicine. 2014;9:3527-3538. doi:10.2147/IJN.S63507
  8. Generali JA, Cada DJ. Recombinant human growth hormone: HIV-related lipodystrophy. Hosp Pharm. 2014;49(5):432-434. doi:10.1310/hpj4905-432
  9. National Institute of Allergy and Infectious Diseases (NIAID). Improving immune reconstitution with growth hormone in HIV-infected subjects with incomplete CD4+ lymphocyte restoration on highly active antiretroviral therapy (HAART). In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on December 30, 2002. NLM Identifier: NCT00050921. https://clinicaltrials.gov/ct2/show/NCT00050921. Accessed April 24, 2019.
  10. National Institute of Allergy and Infectious Diseases (NIAID). The use of recombinant growth hormone to enhance T-cell production in adults infected with HIV-1. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on October 16, 2003. NLM Identifier: NCT00071240. https://clinicaltrials.gov/ct2/show/NCT00071240. Accessed April 24, 2019.
  11. Germans Trias i Pujol Hospital. Double strategy to induce and expand the T cell repertoire by the administration of growth hormone and vaccination in HIV-1 Infected patients. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on February 6, 2006. NLM Identifier: NCT00287677. https://clinicaltrials.gov/ct2/show/NCT00287677. Accessed April 24, 2019.
  12. Hvidovre University Hospital. The effect of low-dose human growth hormone therapy in HIV infected patients on highly active antiretroviral therapy (HAART). In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on July 7, 2005. NLM Identifier: NCT00119769. https://clinicaltrials.gov/ct2/show/NCT00119769. Accessed April 24, 2019.
  13. Imperial College London. A randomised, open labelled, Phase I, safety, toxicity, and exploratory immunogenicity evaluation of therapeutic immunisation +/- IL-2, GM-CSF and growth hormone in HIV-1 infected subjects receiving highly active anti-retroviral therapy. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on May 25, 2010. NLM Identifier: NCT01130376. https://clinicaltrials.gov/ct2/show/NCT01130376. Accessed April 24, 2019.
  14. Herasimtschuk A, Downey J, Nelson M, et al. Therapeutic immunisation plus cytokine and hormone therapy improves CD4 T-cell counts, restores anti-HIV-1 responses and reduces immune activation in treated chronic HIV-1 infection. Vaccine. 2014;32(51):7005-7013.
  15. Smith K, Zheng L, Bosch R, et al. Treatment with recombinant growth hormone is associated with modest improvement in CD4 lymphocyte reconstitution in HIV-infected persons on antiretroviral therapy: results of ACTG A5174. AIDS Res Hum Retroviruses. 2010;26(4):425-432. doi:10.1089/aid.2009.0052
  16. Napolitano LA, Schmidt D, Gotway MB, et al. Growth hormone enhances thymic function in HIV-1–infected adults. J Clin Invest. 2008;118(3):1085-1098. doi:10.1172/JCI32830
  17. Plana M, Garcia F, Darwich L, et al. The reconstitution of the thymus in immunosuppressed individuals restores CD4-specific cellular and humoral immune responses. Immunology. 2011;133(3):318-328. doi:10.1111/j.1365-2567.2011.03442.x

Last Reviewed: April 24, 2019

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