Phase I/II trial of intravenous recombinant interleukin-2 in HIV-infected children
SE Starr, EJ McFarland, P Muresan, T Fenton, J Pitt… - Aids, 2003 - journals.lww.com
SE Starr, EJ McFarland, P Muresan, T Fenton, J Pitt, SD Douglas, A Deveikis, MJ Levin…
Aids, 2003•journals.lww.comMain outcome measures: Toxicity, CD4 cell count and percentage, and viral load. Results:
The tolerated dose of rIL-2 was 1× 10 6 IU/m 2. The most common side effects were fever
and vomiting. Of 10 subjects enrolled in part B of the study, five discontinued rIL-2 therapy
for a variety of reasons, most related to administration of study drug. Comparable rises in
CD4 cell count and percentage were observed in each of the treatment arms. Six cycles of
rIL-2 therapy did not appear to be better than three cycles with respect to improvement of …
The tolerated dose of rIL-2 was 1× 10 6 IU/m 2. The most common side effects were fever
and vomiting. Of 10 subjects enrolled in part B of the study, five discontinued rIL-2 therapy
for a variety of reasons, most related to administration of study drug. Comparable rises in
CD4 cell count and percentage were observed in each of the treatment arms. Six cycles of
rIL-2 therapy did not appear to be better than three cycles with respect to improvement of …
Main outcome measures:
Toxicity, CD4 cell count and percentage, and viral load.
Results:
The tolerated dose of rIL-2 was 1× 10 6 IU/m 2. The most common side effects were fever and vomiting. Of 10 subjects enrolled in part B of the study, five discontinued rIL-2 therapy for a variety of reasons, most related to administration of study drug. Comparable rises in CD4 cell count and percentage were observed in each of the treatment arms. Six cycles of rIL-2 therapy did not appear to be better than three cycles with respect to improvement of CD4 parameters. Transient rises in plasma HIV-1 RNA levels were detected in some subjects.
Conclusions:
These results suggest that rIL-2 therapy can raise CD4 cell counts and percentages in some HIV-infected children, although a high proportion of HIV-infected children may have to discontinue intravenous therapy because of drug-or administration-related toxicity. Controlled trials of rIL-2 in this patient population are warranted.
Lippincott Williams & Wilkins