TABLE 1.
Selected Baseline Characteristics by Treatment Assignment for Participants in the Parent Study and DEXA Substudy
| All Treated Patients | Patients in the DEXA Substudy | |||
|---|---|---|---|---|
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|
|
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| Raltegravir Group | Efavirenz Group | Raltegravir Group | Efavirenz Group | |
|
|
|
|
|
|
| (n = 281) | (n = 282) | (n = 55)* | (n = 57)* | |
| Gender, n (%) | ||||
| Male | 227 (81) | 231 (82) | 51 (93) | 48 (84) |
| Female | 54 (19) | 51 (18) | 4 (7) | 9 (16) |
| Race/ethnicity, n (%) | ||||
| White | 116 (41) | 123 (44) | 34 (62) | 33 (58) |
| Black | 33 (12) | 23 (8) | 14 (25) | 9 (16) |
| Asian | 36 (13) | 32 (11) | 0 (0) | 1 (2) |
| Hispanic | 60 (21) | 67 (24) | 5 (9) | 11 (19) |
| Native American | 1 (0.4) | 1 (0.4) | 0 (0) | 1 (2) |
| Multiracial | 35 (12) | 36 (13) | 2 (4) | 2 (4) |
| Region, n (%) | ||||
| Latin America | 99 (35) | 97 (34) | — | — |
| South Asia | 34 (12) | 29 (10) | — | — |
| North America | 82 (29) | 90 (32) | 55 (100) | 57 (100) |
| Europe/Australia | 66 (23) | 66 (23) | — | — |
| Age, in yrs | ||||
| Mean (SD) | 38 (9) | 37 (10) | 37 (9) | 40 (10) |
| Median (min to max) | 37 (19–67) | 36 (19–71) | 38 (20–61) | 39 (21–67) |
| CD4 cell count, cell/mm3 | ||||
| Mean (SD) | 219 (124) | 217 (134) | 236 (157) | 226 (149) |
| Median (min to max) | 212 (1–620) | 204 (4–807) | 231 (1–609) | 202 (6–567) |
| Plasma HIV RNA, log 10 copies/mL | ||||
| Mean (SD) | 5.0 (0.6) | 5.0 (0.6) | 5.0 (0.6) | 5.0 (0.6) |
| Median (min to max) | 5.1 (3–6) | 5.0 (4–6) | 4.9 (4–6) | 5.0 (4–6) |
| Investigator-reported history of AIDS | ||||
| Yes | 52 (19) | 59 (21) | 10 (18) | 8 (14) |
| Stratum, n (%) | ||||
| Screening HIV RNA level ≤50,000 | 75 (27) | 80 (28) | 16 (29) | 15 (26) |
| Hepatitis B or C positive | 18 (6) | 16 (6) | 2 (4) | 4 (7) |
| Viral Subtype, n (%) | ||||
| Clade B | 219 (78) | 230 (82) | 53 (96) | 52 (91) |
| Non-Clade B | 59 (21) | 47 (17) | 2 (4) | 3 (5) |
| Missing | 3 (1) | 5 (2) | 0 (0) | 2 (4) |
| Baseline plasma HIV RNA, n (%) | ||||
| ≤50,000 copies/mL | 79 (28) | 84 (30) | 19 (35) | 19 (33) |
| >50,000 copies/mL | 202 (72) | 198 (70) | 36 (65) | 38 (67) |
| ≤100,000 copies/mL | 127 (45) | 139 (49) | 31 (56) | 27 (47) |
| >100,000 copies/mL | 154 (55) | 143 (51) | 24 (44) | 30 (53) |
| Baseline CD4 cell counts, n (%) | ||||
| ≤50 cells/mm3 | 27 (10) | 31 (11) | 8 (15) | 9 (16) |
| >50 cells/mm3 and ≤200 cells/mm3 | 104 (37) | 105 (37) | 15 (27) | 19 (33) |
| >200 cells/mm3 | 150 (53) | 145 (51) | 32 (58) | 29 (51) |
| Missing | 0 (0) | 1 (0.4) | 0 (0) | 0 (0) |
| Body mass at baseline | ||||
| Mean weight in kg (SD) | 72 (15) | 70 (16) | 83 (15) | 77 (23) |
| Mean BMI in kg/M2(SD) | 24 (5) | 24 (5) | 27 (6) | 25 (6) |
*
There were 111 patients with Dual Energy X-ray Absorptiometry (DEXA) scans at baseline: 86 patients were evaluable at Week 48 and 75 patients were evaluable Week 96, including 68 patients evaluable at both time points. One patient enrolled in the substudy from the efavirenz arm did not have a baseline scan and therefore was excluded from the DEXA analyses.
Dash indicates that only participants at US sites were eligible for the DEXA substudy.
n, number of patients; BMI, body mass index; SD, standard deviation.