TABLE 3.
Summary of clinical characteristics of study participantsa
| Stratum definition (viral load) | No. of subjects | Median (range) viral load (copies/ml) | Median (range) CD4 count (cells/μl) | No. of subjects tested by: |
||
|---|---|---|---|---|---|---|
| Screening (ELISPOT assay + HLA restriction) | Tetramer staining | Intracellular cytokine staining | ||||
| Controllers (<50–2,000 copies/ml) | 34 | 400 (20–2,000) | 684.5 (340–1,162) | 30 | 11 | 6 |
| Progressors (2,001– >50,000 copies/ml) | 46 | 26,800 (2,100–4,540,000) | 415.5 (225,934) | 42 | 10 | 8 |
| Total | 80 | 72 | 21 | 14 | ||
Patient demographics were as follows: by sex, 76.3% were female (n = 61) and 23.8% were male (n = 19), and by race, 97.5% were African and 1.2% each were Asian and Caucasian (percentages do not total 100% because of rounding). All study participants included in the tetramer and intracellular cytokine staining studies maintained viral control for a minimum of 1 year, including at the time point of analysis in the case of controllers, and had comparable CD4 cell counts (P = 0.87). Individuals utilized for the initial screening and HLA restriction assays were not necessarily the same individuals used to perform tetramer and intracellular cytokine staining.