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Previous Volume 336:1343-1349 May 8, 1997 Number 19 Next

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ABSTRACT

Background In infants and children with maternally acquired human immunodeficiency virus type 1 (HIV-1) infection, treatment with a single antiretroviral agent has limited efficacy. We evaluated the safety and efficacy of a three-drug regimen in a small group of maternally infected infants.

Methods Zidovudine, didanosine, and nevirapine were administered in combination orally to eight infants 2 to 16 months of age. The efficacy of antiretroviral treatment was evaluated by serial measurements of plasma HIV-1 RNA, quantitative plasma cultures, and quantitative cultures of peripheral-blood mononuclear cells.

Results The three-drug regimen was well tolerated, without clinically important adverse events. Within four weeks, there were reductions in plasma levels of HIV-1 RNA of at least 96 percent (1.5 log) in seven of the eight study patients. Over the 6-month study period, replication of HIV-1 was controlled in two infants who began therapy at 2 1/2 months of age. Plasma RNA levels were reduced by 0.5 to 1.5 log in five of the other six infants.

Conclusions Although further observations are needed, it appears that in infants with maternally acquired HIV-1 infection, combined treatment with zidovudine, didanosine, and nevirapine is well tolerated and has sustained efficacy against HIV-1.

Source Information

From the Department of Pediatrics, University of Massachusetts Medical School, Worcester (K.L., J.L.S.); the Department of Pediatrics, University of California at Los Angeles, Los Angeles (Y.B., P.K.); the Department of Pediatrics, University of Connecticut Medical School, Farmington (J.R.); the Department of Pediatrics, Baystate Medical Center, Springfield, Mass. (B.S.); and Boehringer–Ingelheim Pharmaceuticals, Ridgefield, Conn. (M.L., S.C.).

Address reprint requests to Dr. Luzuriaga at Pediatrics and Molecular Medicine, University of Massachusetts Medical School, Rm. 318, Biotech 2, 373 Plantation St., Worcester, MA 01605.

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