Recombinant CD4-IgG2 in human immunodeficiency virus type 1-infected children: Phase 1/2 study

The use of recombinant CD4-IgG2 in pediatric human immunodeficiency virus t ype 1 (HIV-1) infection was evaluated by single and multidose intravenous i nfusions in 18 children in a phase 1/2 study. The study drug was well toler ated, and dose proportionality was observed in terms of area under time-con centration curve and peak serum concentration. Acute decreases of >0.7 log( 10) copies/mL in serum HIV-1 RNA concentration were seen in 4 of the 6 chil dren treated with 4 weekly 10 mg/kg doses. At 14 days after treatment, 3 ch ildren had sustained reductions in serum HIV-I RNA; the other children had rebounded to baseline levels or above. By 28 days after therapy, the peak H IV-1 cellular infectious units was reduced in all 6 children, including the 2 who had experienced an earlier transient increase in values. Thus, recom binant CD4-IgG2 treatment of HIV-l-infected children appears to be well tol erated and capable of reducing HIV-1 burden.