Abstract | BACKGROUND: METHODS: In AIDS Clinical Trials Group A5212, a randomized, double-blind, placebo-controlled study, 99 HIV-infected patients on ART with plasma HIV-1 RNA levels ≤200 copies per milliliter for ≥6 months and CD4 lymphocyte counts <200 cells per cubic milliliter were randomized 1:1:1:1 to receive once daily intravenous administration of placebo or 20, 40, or 60 μg/kg of palifermin on 3 consecutive days. RESULTS: The median change in the CD4 T-cell count from baseline to week 12 was not significantly different between the placebo arm [15 (-16, 23) cells/mm] and the 20-μg/kg dose [11 (2, 32) cells/mm], the 40-μg/kg dose [12 (-2, 25) cells/mm], or the 60-μg/kg dose arm [8 (-13, 35) cells/mm] of palifermin. No significant changes were observed in thymus size or in the number of naive T cells or recent thymic emigrants. CONCLUSIONS:
Palifermin in the doses studied was not effective in improving thymic function and did not raise CD4 lymphocyte counts in HIV-infected patients with low CD4 cell counts despite virologically effective ART.
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Authors | Jeffrey M Jacobson, Hongying Wang, Rebeka Bordi, Lu Zheng, Barry H Gross, Alan L Landay, John Spritzler, Jean-Pierre Routy, Constance Benson, Judith Aberg, Pablo Tebas, David W Haas, Jennifer Tiu, Kristine Coughlin, Lynette Purdue, Rafick-Pierre Sekaly, AIDS Clinical Trials Group (ACTG) A5212 Protocol Team |
Journal | Journal of acquired immune deficiency syndromes (1999)
(J Acquir Immune Defic Syndr)
Vol. 66
Issue 4
Pg. 399-406
(Aug 01 2014)
ISSN: 1944-7884 [Electronic] United States |
PMID | 24815851
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural)
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Chemical References |
- Anti-HIV Agents
- RNA, Viral
- Recombinant Proteins
- Fibroblast Growth Factor 7
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Topics |
- Adult
- Anti-HIV Agents
(therapeutic use)
- CD4 Lymphocyte Count
- Dose-Response Relationship, Drug
- Double-Blind Method
- Female
- Fibroblast Growth Factor 7
(administration & dosage, pharmacology)
- HIV Infections
(drug therapy, immunology)
- HIV-1
- Humans
- Male
- Middle Aged
- RNA, Viral
- Recombinant Proteins
- Thymus Gland
(drug effects)
- Viral Load
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