Table 1.
Baseline characteristics
| Total (N=399) Median [IQR] or N (%) |
Immediate ART group
(N=195) Median or % |
Deferred ART group
(N=204) Median or % |
|
|---|---|---|---|
| Demographics | |||
| Age (years) | 32 [26, 41] | 32 | 33 |
| Sex | |||
| Male | 295 (73.9) | 73.3 | 74.5 |
| Premenopausal female | 91 (22.8) | 24.1 | 21.6 |
| Postmenopausal female | 13 (3.3) | 2.6 | 3.9 |
| Race | |||
| Asian | 126 (31.6) | 30.8 | 32.4 |
| Black | 74 (18.5) | 16.9 | 20.1 |
| Latino/Hispanic | 97 (24.3) | 25.6 | 23.0 |
| White | 80 (20.1) | 19.5 | 20.6 |
| Other | 22 (5.5) | 7.2 | 3.9 |
| Clinical factors | |||
| Previous fracture (any)a | 31 (7.8) | 8.7 | 6.9 |
| Previous fragility fracture a | 17 (4.3) | 4.1 | 4.4 |
| BMI (kg/m2) | 23.9 [21.4, 27.3] | 24.1 | 23.8 |
| Current smoker | 77 (19.3) | 16.9 | 21.6 |
| Alcohol useb | 16 (4.0) | 4.6 | 3.4 |
| Current medication use | |||
| Corticosteroids | 1 (0.3) | 0.0 | 0.5 |
| Vitamin D | 22 (5.5) | 4.1 | 6.9 |
| Calcium supplements | 19 (4.8) | 4.1 | 5.4 |
| Hormone replacement therapy | 1 (0.3) | 0.0 | 0.5 |
| HIV History | |||
| Known HIV duration (years) | 0.7 [0.3, 2.8] | 0.6 | 0.9 |
| ART, pre-specified prior to randomization | |||
| Tenofovir DF | 334 (83.7) | 83.1 | 84.3 |
| Efavirenz | 333 (83.5) | 82.6 | 84.3 |
| Protease inhibitor | 42 (10.5) | 11.8 | 9.3 |
| Laboratory Results | |||
| CD4 count (cells/μL) | 642 [579, 738] | 644 | 640 |
| HIV viral load (copies/mL) | 14940 [3399, 53293] | 20257 | 12332 |
| eGFR (mL/min/1.73 m2)d | 114.0 [98.9, 122.4] | 114.2 | 113.4 |
| Bone Mineral Density | |||
| Spine | |||
| BMD (g/cm2) | 1.01 [0.94, 1.11] | 1.02 | 1.01 |
| T-score e | −0.31 [−1.00, 0.59] | −0.24 | −0.33 |
| Z-score f | −0.66 [−1.33, 0.25] | −0.63 | −0.69 |
| Total Hip | |||
| BMD (g/cm2) | 0.96 [0.87, 1.04] | 0.94 | 0.97 |
| T-score e | 0.14 [−0.61, 0.84] | 0.02 | 0.24 |
| Z-score f | −0.37 [−0.94, 0.18] | −0.47 | −0.31 |
| Femoral Neck | |||
| BMD (g/cm2) | 0.84 [0.76, 0.93] | 0.83 | 0.85 |
| T-score e | −0.06 [−0.84, 0.77] | −0.16 | 0.04 |
| Z-score f | −0.44 [−1.05, 0.19] | −0.53 | −0.39 |
| Low BMD relative to age groupg | 45 (11.3) | 13.3 | 9.3 |
| T-score ≤−2.5 at the spine, hip or femoral neck | 8 (2.0) | 3.1 | 1.0 |
Fractures after age of 18. Fragility fracture defined as fracture occurring following fall from standing height or equivalent.
Consumed alcohol four to seven days a week with at least 2 drinks per day.
Current recreational drug use, at least once in the past month.
eGFR was calculated using the CKD-EPI formula.
BMD T-scores were standardized relative to young adult Caucasian women.
BMD Z-scores were standardized relative to age, gender and race/ethnicity (black/white/hispanic) matched reference populations. White reference populations are used for all other races/ethnicities.
BMD Z-score ≤ −2 at the lumbar spine, hip or femoral neck.
Tenofovir DF, Tenofovir disoproxil fumarate; NSAID, nonsteroidal anti-inflammatory drug; eGFR, estimated glomerular filtration rate.