Jb. Angel et al., A multicenter, randomized, double-blind, placebo-controlled trial of recombinant human interleukin-10 in HIV-infected subjects, AIDS, 14(16), 2000, pp. 2503-2508
Objective: To determine the effect of multiple subcutaneous doses of recomb
inant human interleukin (rhulL)-10 on plasma HIV RNA levels and CD4 T-cell
counts, and to evaluate its safety and tolerability in HIV-infected subject
s.
Design: Prospective, randomized, double-blind, placebo-controlled, multicen
ter trial.
Subjects: Thirty-nine HIV-infected subjects with CD4 T-cell counts > 200 x
10(6)/l, plasma HIV RNA concentrations greater than or equal to 3.18 log(10
) copies/ml and on stable antiretroviral therapy were recruited from six ce
nters.
Intervention: Subjects received (subcutaneously) rhulL-10 1 mug/kg daily, 4
mug/kg daily, 8 mug/kg three times per week, placebo daily or placebo thre
e times per week for 4 weeks.
Main outcome measures: Prospectively defined outcomes included safety and t
olerability, plasma HIV RNA levels and CD4 T-cell counts. Outcomes were ass
essed at baseline, weeks 1, 2, 3 and 4 during treatment and weeks 2 and 4 f
ollowing completion of therapy.
Results: Baseline characteristics were similar in all groups. Compared to b
aseline, no significant change in plasma HIV RNA concentrations or CD4 T-ce
ll counts was observed in any of the groups. RhulL-10 was generally well to
lerated. Two patients receiving rhulL-10 4 mug/kg required discontinuation
due to thrombocytopenia. One patient receiving rhulL-10 4 mug/kg who had ch
ronic hepatitis B and C infections discontinued drug because of elevated li
ver function tests. One patient receiving placebo discontinued study drug b
ecause of depression.
Conclusion: The lack of a demonstrable virological benefit, as assessed by
plasma viral load, with 4 weeks of rhulL-10 does not support the developmen
t of this immune-based therapy for treatment of HIV infection. (C) 2000 Lip
pincott Williams & Wilkins.