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.

TitleTreatment with recombinant growth hormone is associated with modest improvement in CD4 lymphocyte reconstitution in HIV-infected persons on antiretroviral therapy: results of ACTG A5174.
Publication TypeJournal Article
Year of Publication2010
AuthorsSmith K, Zheng L, Bosch R, Margolis DM, Tenorio A, Napolitano L, Saag M, Connick E, Gross B, Francis I, Valdez H, Muurahainen N, Stocker V, Pollard R
JournalAIDS Res Hum Retroviruses
Volume26
Issue4
Pagination425-32
Date Published2010 Apr
ISSN1931-8405
KeywordsAdolescent, Adult, Anti-Retroviral Agents, CD4-Positive T-Lymphocytes, Drug Administration Schedule, Female, HIV Infections, HIV-1, Human Growth Hormone, Humans, Leukocytes, Mononuclear, Lymphocyte Count, Male, Middle Aged, Pilot Projects, Recombinant Proteins, T-Lymphocyte Subsets, Thymus Gland, Treatment Outcome
Abstract

Pilot studies have suggested that treatment with recombinant human growth hormone (rhGH) is associated with increased T-lymphocyte restoration and enhanced thymic output. We evaluated the immunologic effects of rhGH on HIV(+) subjects with incomplete immune reconstitution on antiretroviral therapy (ART). Sixty subjects were randomized to receive rhGH 1.5 mg scqd and ART for 48 weeks (Arm A) or continue ART alone for 24 weeks then add rhGH 3.0 mg scqd for 24 weeks (Arm B). Median baseline CD4 for Arms A and B were 223 and 219, respectively. There was little difference between Arm A and Arm B in change in total or naive CD4 cells or percentage from baseline to week 24. Only one subject in Arm A met the primary endpoint, an increase in naive CD4 percentage of at least 10 percentage points. By week 48 both Arms had statistically significant increases in naive CD4 cell count and percentage and thymus size. Within Arm B, treatment with rhGH was associated with significant increases in naive CD4(+) cell count and percentage compared with ART alone. Treatment with rhGH +ART may be associated with modest increases in CD4 lymphocytes over ART alone in subjects with CD4 <350, yet the origin of these naive cells and their impact on immune function require further investigation.

DOI10.1089/aid.2009.0052
Alternate JournalAIDS Res. Hum. Retroviruses
PubMed ID20415638
PubMed Central IDPMC2864047
Grant List1U01AI 069424 01 / AI / NIAID NIH HHS / United States
1U01AI06452-01 / AI / NIAID NIH HHS / United States
1U01AI068634-01 / AI / NIAID NIH HHS / United States
1U01AI069423-01 / AI / NIAID NIH HHS / United States
1U01AI069450 / AI / NIAID NIH HHS / United States
1U01AI069471-01 / AI / NIAID NIH HHS / United States
1U01AI069501-01 / AI / NIAID NIH HHS / United States
1U01AI069502-01 / AI / NIAID NIH HHS / United States
5 U01AI38855 / AI / NIAID NIH HHS / United States
AI38858 / AI / NIAID NIH HHS / United States
AI68634 / AI / NIAID NIH HHS / United States
AI68636 / AI / NIAID NIH HHS / United States
U01 AI069423 / AI / NIAID NIH HHS / United States