Comparison of subjects with and without increases in HIV-1 virus load during stem cell mobilization and harvesting
| Variable . | HIV-1 RNA Maximum Increase* . | ||
|---|---|---|---|
| <0.6 log10 (n = 9) . | ≥0.6 log10 (n = 9) . | P . | |
| Number of subjects in cohort 1 | 3 | 3 | |
| Number of subjects in cohort 2 | 4 | 2 | .84† |
| Number of subjects in cohort 3 | 2 | 4 | |
| Age (years)‡ | 40 | 42 | >.99 |
| Baseline CD4+ lymphocytes (cells/μL)‡ | 278 | 338 | .23 |
| Baseline HIV-1 RNA (log10 copies/mL)‡ | 3.11 | 3.5 | .53 |
| Number of subjects on ARV | 6 | 5 | .632-153 |
| Maximum peripheral CD4+ lymphocytes (cells/μL)‡ | 557 | 608 | .44 |
| CD4+ lymphocyte count increase from baseline (%)‡,2-154 | 79 | 86 | .44 |
| CD4+ lymphocyte count change from baseline, day 27 (%)‡,2-154 | −25 | −25 | .86 |
| Maximum peripheral CD34+ count (cells/μL)‡,2-155 | 63 | 39 | .93 |
| Number of subjects with positive HIV-1 culture findings# | 4 | 5 | .642-153 |
| Variable . | HIV-1 RNA Maximum Increase* . | ||
|---|---|---|---|
| <0.6 log10 (n = 9) . | ≥0.6 log10 (n = 9) . | P . | |
| Number of subjects in cohort 1 | 3 | 3 | |
| Number of subjects in cohort 2 | 4 | 2 | .84† |
| Number of subjects in cohort 3 | 2 | 4 | |
| Age (years)‡ | 40 | 42 | >.99 |
| Baseline CD4+ lymphocytes (cells/μL)‡ | 278 | 338 | .23 |
| Baseline HIV-1 RNA (log10 copies/mL)‡ | 3.11 | 3.5 | .53 |
| Number of subjects on ARV | 6 | 5 | .632-153 |
| Maximum peripheral CD4+ lymphocytes (cells/μL)‡ | 557 | 608 | .44 |
| CD4+ lymphocyte count increase from baseline (%)‡,2-154 | 79 | 86 | .44 |
| CD4+ lymphocyte count change from baseline, day 27 (%)‡,2-154 | −25 | −25 | .86 |
| Maximum peripheral CD34+ count (cells/μL)‡,2-155 | 63 | 39 | .93 |
| Number of subjects with positive HIV-1 culture findings# | 4 | 5 | .642-153 |
ARV, antiretroviral therapy; PBMC, peripheral blood mononuclear cells.
Subjects were divided into 2 groups based on the maximum increase of HIV-1 RNA levels above baseline during study days 5 through 7. Each of the indicated variables was compared for the 2 groups by a 2-tailed Wilcoxon rank sum test except where indicated.
Fisher exact test for combined cohorts 1, 2, and 3.
Values are the median.
z-test for comparing 2 binomial proportions.
Maximum value during days 4 through 7.
((CD4+ count − baseline CD4+ count) / (baseline CD4+ count)) × 100.
#Ability to propagate HIV-1 by coculture of cells in leukapheresis product obtained on day 4 or 5. HIV-1 culture was taken for 8 subjects with <0.6 log10 increase and for 8 subjects with ≥0.6 log10 increase in plasma HIV-1 RNA level.