Table 1.
Demographic and other characteristics of subjects, by study group
| Group 1: Acute Treatment (≤30 days) (n= 47) | Group 2: Early Treatment (31–180 days) (n=89) | Group 3: Delayed Treatment (≥181 days) (n=47) | Never Treated Historical Controls (n=27) | Never Treated Contemporary Controls (n=69) | Total (n=279) | |||
|---|---|---|---|---|---|---|---|---|
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| Age (mean years, s.d.) | 36 (8) | 34 (7) | 35 (8) | 29 (9) | 34 (8) | 34 (8) | p=.006 | |
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| Male | 100% | 99% | 98% | 93% | 98% | 98% | NS | |
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| Caucasian, non-Hispanic | 83% | 89% | 89% | 81% | 80% | 85% | NS | |
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| HIV risk factor | MSM | 44 (94%) | 83 (93%) | 43 (91%) | 20 (74%) | 64 (93%) | 254 (91%) | NS |
| MSM-IVDU | 1 (2%) | 2 (2%) | 2 (4%) | 3 (11%) | 4 (6%) | 12 (4%) | ||
| IVDU | - | 1 (1%) | - | 1 (4%) | - | 2 (1%) | ||
| Heterosexual | 1 (2%) | 3 (3%) | 1 (2%) | 2 (7%) | 1 (1%) | 8 (3%) | ||
| Other | 1 (2%) | - | 1 (2%) | 1 (4%) | - | 3 (1%) | ||
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| Severity of symptoms of acute retroviral syndrome | none | - | 12 (13%) | 9 (19%) | 4 (15%) | 20 (29%) | 45 (16%) | p<.001 |
| mild | 3 (6%) | 17 (19%) | 8 (17%) | 4 (15%) | 17 (25%) | 49 (18%) | ||
| moderate | 12 (26%) | 24 (27%) | 13 (28%) | 6 (22%) | 12 (17%) | 67 (24%) | ||
| severe | 27 (57%) | 33 (37%) | 17 (36%) | 8 (30%) | 18 (26%) | 103 (37%) | ||
| hospitalized | 5 (11%) | 3 (3%) | - | 5 (19%) | 2 (3%) | 15 (5%) | ||
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| Number of days from HIV infection to study screening (median, IQR) | 13 (10–18) | 50 (29–79) | 83 (28–125) | 78 (50–105) | 45 (24–81) | 43 (21–83) | p=.0001 | |
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| Date of study screening (median month/year, IQR) | 12/02 (6/00–2/05) | 12/00 (6/98–4/03) | 8/99 (3/96–10/03) | 1/94 (6/93–11/94) | 9/04 (1/01–2/07) | 6/01 (1/98–7/04) | ||
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| Baseline CD4+ T-cell count (mean cells/mm3, s.d.) | 437 (229)1 | 559 (211) 1 | 650 (277) 1 | 617 (250) 2 | 652 (244) 2 | 582 (248) | ||
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| Baseline HIV RNA level, (mean log10 copies/mL, s.d.) | 6.0 (1.0) 1 | 4.9 (0.9) 1 | 4.4 (1.1) 1 | 4.8 (0.6) 2 | 4.1 (1.3) 2 | 4.8 (1.2) | ||
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| Number of days from infection to HAART (median, IQR) | 21 (15–24) | 80 (45–108) | 822 (410–1424) | NA | NA | |||
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| Initial HAART regimen | PI | 34 (72%) | 40 (45%) | 21 (46%) | NA | NA | 95 (52%) | p<.001 |
| NNRTI | 8 (17%) | 34 (38%) | 24 (52%) | 66 (36%) | ||||
| PI/NNRTI | 4 (9%) | 14 (16%) | 0 (0%) | 18 (10%) | ||||
| II or II/NNRTI | 1 (2%) | 0 (0%) | 1 (2%) | 2 (1%) | ||||
| NRTI only | 0 (0%) | 1 (1%) | 1 (2%) | 2 (1%) | ||||
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| Duration of study follow-up (median years, IQR) | 3.6 (1.2–6.4) | 4.9 (2.7–7.8) | 6.0 (3.4–9.6) | 0.8 (0.3–1.8) | 1.8 (0.5–3.3) | 3.5 (1.2–6.6) | p=.0001 | |
s.d.: standard deviation; NS: not significant; MSM: men who have sex with men; IVDU: intravenous drug use; IQR: interquartile range; HAART: highly active antiretroviral therapy; PI: protease inhibitor therapy; NNRTI: non-nucleoside reverse transcriptase inhibitor therapy; II: integrase inhibitor; NRTI: nucleoside reverse transcriptase inhibitor; NA: not applicable
Tests for linear trend across treatment groups, by ordinary least squares regression with robust standard errors, adjusted for time since HIV infection: p=.003 (CD4) and p=.001 (HIV RNA).
Tests for differences between control groups, by ordinary least squares regression with robust standard errors, adjusted for time since infection, p=0.29 (CD4) and p<.0001 (RNA)