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Table 1 Baseline demographics and disease characteristics

From: Abacavir, efavirenz, didanosine, with or without hydroxyurea, in HIV-infected adults failing initial nucleoside/protease inhibitor-containing regimens

Characteristic ABC/EFV/ddI (N = 24) ABC/EFV/ddI/HU (N = 30)
Age, years   
   Mean ± SD 39.5 ± 7.8 38.1 ± 8.4
   Median (Range) 37 (29–62) 37 (26–59)
Gender, n (%)   
   Male 21 (88) 26 (87)
   Female 3 (13) 4 (13)
Race, n (%)   
   Caucasian 13 (54) 16 (53)
   African American 8 (33) 4 (13)
   Hispanic 2 (8) 7 (23)
   Other 1 (4) 3 (10)
CDC classification, n (%)   
   Category A 9 (38) 19 (63)
   Category B 10 (42) 5 (17)
   Category C 5 (21) 6 (20)
HIV-1 RNA, log10 copies/mL   
   Mean ± SD 3.86 ± 0.55 3.86 ± 0.67
   Median (Range) 3.93 (2.86–4.73) 3.90 (2.73–4.82)
CD4 cell count, cells/mm3   
   Mean ± SD 345 ± 192 346 ± 167
   Median (Range) 291 (67–805) 326 (53–794)
Prior antiretroviral treatment, n (%)   
   NRTIs 24 (100) 29 (97)
Lamivudine 16 (67) 19 (63)
Stavudine 11 (46) 18 (60)
Lamivudine/zidovudine combination tablet 10 (42) 10 (33)
Zidovudine 5 (21) 4 (13)
Zalcitabine 0 1 (3)
   PIs 22 (92) 26 (87)
Nelfinavir mesylate 10 (42) 17 (57)
Indinavir sulfate 7 (29) 7 (23)
Saquinavir 3 (13) 2 (7)
Ritonavir 1 (4) 2 (7)
Lopinavir + ritonavir 1 (4) 1 (3)
Amprenavir 1 (4) 0
Premature withdrawal from study, n (%) 10 (42) 14 (47)
   Adverse eventa 1 (4) 7 (23)
   Consent withdrawn 2 (8) 0
   Protocol-defined virologic failure 5 (21) 1 (3)
   Lost to follow-up 1 (4) 3 (10)
   Protocol violation 0 1 (3)
   Other 1 (4) 2 (7)
  1. Note: ABC, abacavir; ddI, didanosine; EFV, efavirenz; HU, hydroxyurea; NRTIs, nucleoside reverse transcriptase inhibitors; PIs, protease inhibitors; SD, standard deviation.
  2. aAdverse events that led to premature study withdrawal in the HU arm were diarrhea, dizziness, headaches, vomiting, rash on chest, insomnia (1 patient); pancreatitis (1); decrease in concentration, exacerbation of depression, nightmares (1); fatigue (1); flushing, fatigue, vomiting, nausea, palpitations (1); dizziness, incoherence (1); and possible ABC-related hypersensitivity reaction (1). The one patient in the non-HU arm who withdrew prematurely from the study did so because of fatal asphyxia, which was not considered related to drug treatment.