Table 1.
Characteristics of Clinical Trial Participants Who Subsequently Enrolled Into Long-term Follow-up, by Randomization Group
| LPV/r, N = 119 | EFV, N = 118 | |
|---|---|---|
| n ( %) or Median (IQR) | ||
| Demographic characteristics at the time of randomization | ||
| Child’s sex | ||
| Male | 56 (47.1) | 61 (51.7) |
| Female | 63 (52.9) | 57 (48.3) |
| Child’s age at randomization, years | 3.9 (3.4, 4.7) | 4.0 (3.5, 4.6) |
| Caregiver education, highest grade | ||
| Any primary (1–7) | 8 (6.7) | 11 (9.5) |
| Any high school (8–11) | 63 (52.9) | 48 (41.4) |
| Completed high school | 48 (40.3) | 57 (49.1) |
| Water tap in home | ||
| Yes | 59 (49.6) | 65 (55.6) |
| No | 60 (50.4) | 52 (44.4) |
| Child has gone hungry | ||
| Yes | 14 (11.8) | 20 (17.1) |
| No | 105 (88.2) | 97 (82.9) |
| Clinical characteristics at the time of randomization | ||
| Age at ART initiation, months | 7.0 (3.7, 14.2) | 5.7 (3.7, 11.7) |
| CD4 percent | ||
| <25 | 5 (4.5) | 5 (4.6) |
| ≥25 | 105 (95.5) | 103 (95.4) |
| Weight for age Z-score | −0.8 (−1.6, −0.4) | −0.9 (−1.4, −0.2) |
| Height for age Z-score | −1.5 (−2.0, −0.5) | −1.4 (−2.0, −0.9) |
| BMI for age Z-score | −0.1 (−0.6, 0.6) | 0.0 (−0.7, 1.0) |
| Clinical characteristics at final (week 48) clinical trial visit | ||
| CD4 percent | ||
| <25 | 8 (7.0) | 3 (2.8) |
| ≥25 | 106 (93.0) | 106 (97.2) |
| Plasma HIV RNA, copies/mL | ||
| ≤50 | 104 (88.1) | 110 (95.7) |
| >50 | 14 (11.9) | 5 (4.3) |
| Weight for age Z-score | −0.8 (−1.6, −0.3) | −0.8 (−1.4, −0.2) |
| Height for age Z-score | −1.3 (−1.9, −0.5) | −1.4 (−2.0, −0.8) |
| BMI for age Z-score | −0.0 (−0.8, 0.6) | 0.1 (−0.6, 1.0) |
| Follow-up time | ||
| Months between last clinical trial visit and observational study enrollment visit | 7.1 (2.1, 17.8) | 7.4 (1.9, 18.7) |
| Months from randomization to last follow-up visit by 31 December 2015 | 47.0 (38.2, 48.0) | 44.5 (36.9, 48.0) |
Abbreviations: ART, antiretroviral therapy; BMI, body mass index; EFV, efavirenz; HIV, human immunodeficiency virus; IQR, interquartile range; LPV/r, ritonavir boosted lopinavir.