Demographics of the study population
. | sc IL-24 . | sc 5003 . | msc IL-25 . |
|---|---|---|---|
| Study purpose | Determine maximally tolerated dose of sc IL-2 | Compare sc IL-2 dosing and schedule | sc IL-2 plus ARV vs ARV alone |
| Study design | Dose escalating | Randomized, open label | Randomized, open label |
| Formal study period | 12 mo | 6 mo | 12 mo |
| CD4 cell count requirement, × 109/L | ≥ 0.2 | ≥ 0.5 | 0.2-0.5 |
| Initial enrollment period | September 1993-June 1994 | May 1995-March 1997 | April 1996-March 1997 |
| Percent protease inhibitor use at baseline | 0 | 15 | 77 |
| Definition for inclusion in long-term follow-up | > 18 mo | > 12 mo | > 18 mo |
| Number enrolled in extension phase | 14 | 43 | 20 |
| Age, y, mean | 38 | 36 | 36 |
| Male sex, % | 93 | 100 | 100 |
| Baseline mean CD4 cell count, × 109/L (%) | 0.371 (22) | 0.655 (32) | 0.425 (24) |
| Baseline mean HIV log10 viral load | 4.14 | 3.51 | 3.15 |
| Total number of IL-2 cycles | 212 | 417 | 162 |
. | sc IL-24 . | sc 5003 . | msc IL-25 . |
|---|---|---|---|
| Study purpose | Determine maximally tolerated dose of sc IL-2 | Compare sc IL-2 dosing and schedule | sc IL-2 plus ARV vs ARV alone |
| Study design | Dose escalating | Randomized, open label | Randomized, open label |
| Formal study period | 12 mo | 6 mo | 12 mo |
| CD4 cell count requirement, × 109/L | ≥ 0.2 | ≥ 0.5 | 0.2-0.5 |
| Initial enrollment period | September 1993-June 1994 | May 1995-March 1997 | April 1996-March 1997 |
| Percent protease inhibitor use at baseline | 0 | 15 | 77 |
| Definition for inclusion in long-term follow-up | > 18 mo | > 12 mo | > 18 mo |
| Number enrolled in extension phase | 14 | 43 | 20 |
| Age, y, mean | 38 | 36 | 36 |
| Male sex, % | 93 | 100 | 100 |
| Baseline mean CD4 cell count, × 109/L (%) | 0.371 (22) | 0.655 (32) | 0.425 (24) |
| Baseline mean HIV log10 viral load | 4.14 | 3.51 | 3.15 |
| Total number of IL-2 cycles | 212 | 417 | 162 |
Populations are as follows: sc IL-2, n = 18; sc 500, n = 53; and msc IL-2, n = 26.