Table 1.
Characteristics of HIV-infected and HIV-exposed uninfected infants from South African sites in IMPAACT P1041
| Characteristic | HIV-infected (N=539)* n (%) |
HIV-uninfected (N=808)* | |
|---|---|---|---|
| Female | 304 (56%) | 396 (49%) | |
|
| |||
| INH randomized group | 271 (50%) | 404 (50%) | |
|
| |||
| Site | Johannesburg | 358 (66%) | 520 (64%) |
| Cape Town | 129 (24%) | 280 (35%) | |
| Durban | 52 (10%) | 8 (1%) | |
|
| |||
| Housing Type | Formal (brick house) | 340 (63%) | 470 (58%) |
| Informal (shack/wooden) | 196 (36%) | 338 (42%) | |
| Dorm/hostel | 2 (<1%) | 0 (0%) | |
|
| |||
| Water access in household | Tap inside house | 187 (35%) | 259 (32%) |
| Tap on plot, single use | 238 (44%) | 315 (39%) | |
| Communal tap | 114 (21%) | 234 (29%) | |
|
| |||
| Ever breastfed | 72 (13%) | 48 (6%) | |
|
| |||
| Mother ever had TB diagnosis | 39 (7%) | 58 (7%) | |
|
| |||
| Study participant birth weight (grams): mean (SD) | 2,819 (565) | 3,026 (471) | |
|
| |||
| WHO weight-for-age z-score: mean (SD) | −1.4 (1.5) | −0.2 (1.1) | |
|
| |||
| CDC clinical HIV category | N | 351 (66%) | |
| A | 141 (26%) | ||
| B | 37 (7%) | ||
| C | 5 (1%) | ||
|
| |||
| CD4%: median (IQR) | 28 (21, 35) | ||
|
| |||
| WHO immunological classification | None | 121 (24%) | |
| Mild | 111 (22%) | ||
| Advanced | 90 (18%) | ||
| Severe | 190 (37%) | ||
|
| |||
| Plasma HIV-1 RNA (copies/ml): median (IQR) | 612,000 (46,000,750,000) | ||
|
| |||
| On ART at or before baseline | 168 (31%) | ||
|
| |||
| Ever initiated ART during P1041 | 450 (83%) | ||
|
| |||
| Age at ART initiation (months): median (IQR) | 4.4 (2.7, 7.2) | ||
|
| |||
| Duration pre-ART during follow-up (weeks): median (IQR) | 8 (0, 23) | ||
|
| |||
| Duration on ART during follow-up (weeks): median (IQR) | 71 (46, 108) | ||
|
| |||
| ART Regimen | 3TC, LPV-r, RTV | 2 (0%) | |
| 3TC, ZDV, LPV-r | 99 (22%) | ||
| 3TC, ZDV, LPV-r, RTV | 5 (1%) | ||
| 3TC, ZDV, NVP | 25 (6%) | ||
| 3TC, ZDV, RTV | 2 (0%) | ||
| d4T, 3TC, EFV | 1 (0%) | ||
| d4T, 3TC, LPV-r | 302 (67%) | ||
| d4T, 3TC, LPV-r, RTV | 7 (2%) | ||
| d4T, 3TC, LPV-r | 1 (0%) | ||
| d4T, 3TC, NVP | 1 (0%) | ||
| d4T, 3TC, RTV | 3 (1%) | ||
| ZDV, 3TC, NVP | 1 (0%) | ||
| ZDV, NVP, LPV-r | 1 (0%) | ||
*
n (%) for categorical variables, mean (SD) or median (IQR) as indicated for continuous variables.
n (%): frequency (percentage of non-missing); SD: standard deviation; IQR: interquartile range, 3TC: lamivudine, LPV-r: lopinavir-ritonavir, RTV: full-dose ritonavir, ZDV: zidovudine, NVP: nevirapine; d4T: stavudine, ART: combination antiretroviral therapy composed of at least 3 drugs from a minimum of 2 classes.
Absolute CD4 counts and CD4% were not measured in HIV-uninfected participants.
CDC HIV clinical classification and ART-use status are not applicable to HIV-uninfected participants.