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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   Consent withdrawn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.