| Autor: |
Berger, D.S., Pobiner, B.F., Mildvan, D., Snidow, J.W., Schleupner, C., Woodward, W.C., Cohen, C.J., Swindells, S., Pakes, G.E., Becker, S., Eron, J., Hernandez, J.E., Green, S., Seekins, D., Cooley, T.P., Richmond, G., Paar, D., Liao, Q., Tashima, K.T., Pearce, D. |
| Jazyk: |
angličtina |
| Rok vydání: |
2005 |
| DOI: |
10.17615/c08e-zb78 |
| Popis: |
Background: Hydroxyurea (HU) is an immunomodulatory agent that has been documented to enhance the antiretroviral activity of nucleoside reverse transcriptase inhibitors, such as abacavir (ABC) and didanosine (ddI), and would be expected to improve virologic efficacy. Methods: A 48-week, phase IV, multicenter, open-label, proof-of-concept clinical trial was conducted to evaluate second-line, protease inhibitor (PI)-sparing therapy with ABC/efavirenz (EFV)/ddl plus HU or without HU in HIV-infected subjects failing to achieve HIV-1 RNA ≤ 400 copies/mL after ≥ 16 weeks of treatment with lamivudine /zidovudine or lamivudine/stavudine, plus 1 or 2 Pls. Subjects were assigned to ABC (300 mg twice daily)/ EFV (600 mg once daily)/ ddI (400 mg once daily) plus HU (500 mg twice daily) (n = 30) or this regimen without HU (n = 24). Results: Baseline mean HIV-1 RNA was 3.86 log10 copies/mL and CD4+ cell count was 345 cells/mm3. A similar percentage of subjects in the non-HU arm (58%) and HU arm (53%) completed the study. Intent-to-treat: missing = failure analysis showed no differences in proportions of subjects in the non-HU and HU arms achieving undetectable plasma HIV-1 RNA levels at week 24 ( |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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