A Study of Zidovudine in Infants Exposed to the HIV Before or Soon After Birth

Summary

To determine if intravenous (IV) and oral zidovudine (AZT) can be safely given to children aged 1 day to 3 months who were born to mothers with an HIV infection. Also to determine the correct dose of AZT for young children. Of a total of 908 pediatric AIDS cases, 78 percent have acquired HIV infection from a mother with HIV infection or at high risk for acquisition of HIV, and the number of cases in children is expected to increase over the next several years. AZT therapy may be effective in altering the course of the disease and decreasing the high mortality in these children. It is also possible that early intervention with AZT may prevent the establishment of HIV contracted before, during, or just after birth.

Timeline

Start

—

Primary completion

—

Completion

—

Publications

• Background Vance E, Guzman J, Bitar M, Kazanjian P. Clarithromycin and zidovudine pharmacokinetic study. Int Conf AIDS. 1994 Aug 7-12;10(2):201 (abstract no PB0816)
• Background Vance E, Watson-Bitar M, Gustavson L, Kazanjian P. Pharmacokinetics of clarithromycin and zidovudine in patients with AIDS. Antimicrob Agents Chemother. 1995 Jun;39(6):1355-60. doi: 10.1128/AAC.39.6.1355.
• Background Boucher FD, Modlin JF, Weller S, Ruff A, Mirochnick M, Pelton S, Wilfert C, McKinney R Jr, Crain MJ, Elkins MM, et al. Phase I evaluation of zidovudine administered to infants exposed at birth to the human immunodeficiency virus. J Pediatr. 1993 Jan;122(1):137-44. doi: 10.1016/s0022-3476(05)83507-3.
• Background Collart L, Blaschke TF, Boucher F, Prober CG. Potential of population pharmacokinetics to reduce the frequency of blood sampling required for estimating kinetic parameters in neonates. Dev Pharmacol Ther. 1992;18(1-2):71-80.
• Background Polis MA, Piscitelli SC, Vogel S, Witebsky FG, Conville PS, Petty B, Kovacs JA, Davey RT Jr, Walker RE, Falloon J, Metcalf JA, Craft C, Lane HC, Masur H. Clarithromycin lowers plasma zidovudine levels in persons with human immunodeficiency virus infection. Antimicrob Agents Chemother. 1997 Aug;41(8):1709-14. doi: 10.1128/AAC.41.8.1709.
• Background Balis FM, Pizzo PA, Eddy J, Wilfert C, McKinney R, Scott G, Murphy RF, Jarosinski PF, Falloon J, Poplack DG. Pharmacokinetics of zidovudine administered intravenously and orally in children with human immunodeficiency virus infection. J Pediatr. 1989 May;114(5):880-4. doi: 10.1016/s0022-3476(89)80158-1.

Drugs

Indications