A controlled trial of granulocyte macrophage-colony stimulating factor during interruption of HAART


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A controlled trial of granulocyte macrophage-colony stimulating factor during interruption of HAART
Fagard  C., Le Braz  M., Gunthard  H., Hirsch  H. H., Egger  M., Vernazza  P., Bernasconi  E., Telenti  A., Ebnother  C., Oxenius  A., Perneger  T., Perrin  L., Hirschel  B.
0269-9370 (Print)
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Clinical Trial
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't --- Old month value: Jul 4
OBJECTIVES: To explore the effect of granulocyte macrophage colony stimulating factor (GM-CSF) on viral load and CD4 cell count during interruption of highly active antiretroviral therapy (HAART). METHODS: Patients on effective HAART (CD4 cell count > 400 x 10(6)/l; viral load < 50 HIV RNA copies/ml) were randomized to one of two groups: 12 weeks' treatment interruption plus, during the first 4 weeks, 300 microg GM-CSF (Leucomax-Novartis) by subcutaneous injection three times weekly (GM-CSF group); 12 weeks' scheduled treatment interruption (STI-only group). Viral load, CD4 cell count, clinical events and side effects of treatment were monitored. RESULTS: Thirty-three patients, 15 in the GM-CSF group and 18 in the STI-only group, were evaluated according to the intention-to-treat principle. The two groups were well matched with regard to pre-HAART viral loads and CD4 cell counts. During STI, viraemia was approximately two to three times lower in the group receiving GM-CSF (max 4.97 versus 5.45 in STI-only group; P = 0.03). Fifteen out of 17 patients in the STI-only group showed a decrease in their CD4 cell count between weeks 0 and 4 (median decrease 231 x 10(6) cells/l; P < 0.001); there was no such tendency in the GM-CSF group (P = non-significant when comparing CD4 cell counts at weeks 0 and 4). The median CD4 cell AUC (area under the curve) from week 0 to week 12 was higher in the GM-CSF group (9166 cells.week) than in patients without GM-CSF (7257), P = 0.02. GM-CSF produced local reactions in 88% of patients, and generalized symptoms such as fever, back pain or headache in 82% of patients. Seventy-six percent of patients completed the planned course of 12 injections. CONCLUSIONS: The administration of GM-CSF blunted the viral rebound following interruption of HAART, and largely prevented a decrease of CD4 cell counts during a 12-weeks-treatment interruption. A better understanding of the underlying mechanism(s) may help to identify synergistic treatment targets and improved administration protocols to enhance control of chronic HIV infection.
Acquired Immunodeficiency Syndrome/*drug therapy/immunology/virology Anti-HIV Agents/*administration & dosage/therapeutic use Antiretroviral Therapy, Highly Active Area Under Curve CD4 Lymphocyte Count Granulocyte Macrophage Colony-Stimulating Factors, Recombinant/adverse effects/*therapeutic use *HIV-1/genetics Humans Pilot Projects RNA, Viral/blood Statistics, Nonparametric Time Factors Treatment Outcome Viral Load
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25/01/2008 15:45
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20/08/2019 15:26
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