Immunological and Virological Changes in Antiretroviral Naïve Human Immunodeficiency Virus Infected Patients Randomized to G‐CSF or Placebo Simultaneously with Initiation of HAART

• Published in: Scandinavian journal of immunology Vol. 51; no. 5; pp. 520 - 525
• Main Authors: Aladdin, H, Ullum, H, Katzenstein, T, Gerstoft, J, Skinhøj, P, Klarlund Pedersen, B
• Format: Journal Article
• Language: English
• Published: Oxford, U.K. and Cambridge, USA Blackwell Science Ltd 01.05.2000; Wiley Subscription Services, Inc
• Subjects: Adult; AIDS/HIV; CD4 antigen; CD8 antigen; Double-Blind Method; Drug Therapy, Combination; Granulocyte Colony-Stimulating Factor - administration & dosage; Granulocyte Colony-Stimulating Factor - therapeutic use; highly active antiretroviral therapy; HIV Infections - blood; HIV Infections - immunology; HIV Infections - physiopathology; HIV Infections - virology; HIV-1 - genetics; Human immunodeficiency virus; Humans; Killer Cells, Natural - cytology; Lymphocytes - cytology; Middle Aged; Neutrophils - cytology; RNA, Viral - blood
• ISSN: 0300-9475; 1365-3083
• DOI: 10.1046/j.1365-3083.2000.00718.x

To determine the efficacy of combined G‐CSF and highly active antiretroviral treatment (HAART), a randomized, double blind, placebo controlled study was conducted. Treatment naive human immunodeficiency virus (HIV) infected patients were randomized to receive either placebo or G‐CSF (0.3 mg/ml, 3 times a week) for 12 weeks and HAART simultaneously. The trial was terminated prematurely after interim analysis performed because of a case of severe encephalopathia in the G‐CSF group. At that point 11 HIV infected patients with a CD4+ T cell count < 350/mm3 had been randomized to the G‐CSF group (n = 6) or placebo group (n = 5). In both groups plasma HIV RNA decreased significantly in response to HAART. However, plasma HIV RNA changed significantly different between the two groups with the decrease being less pronounced in the G‐CSF group (P = 0.02). The concentrations of CD4+ memory T cells and CD8+ naive and memory T cells increased in response to HAART, and there was a trend towards more pronounced increases in several T‐cell subpopulations in the G‐CSF group. The CD56+ NK cells increased significantly more in the G‐CSF group compared with placebo (P = 0.000). All patients in the G‐CSF group reported bone pain. The present data do not support simultaneous administration of G‐CSF with initiation of HAART in treatment naive HIV infected patients.