Ritonavir and Indinavir in Children Failing Other Anti-HIV Treatment

Summary

Both ritonavir (RTV) and indinavir (IDV) are approved by the FDA to treat HIV, but IDV has not been approved for use in children and the doses for the combination of the two drugs has not been studied in children. The purpose of this study is to find a combination of RTV and IDV that is safe, well tolerated, and produces drug levels in the blood of children that are comparable to effective drug levels in the blood of adults. The effectiveness of the drug combination in decreasing the amount of virus in the body will also be studied. The children enrolled in this study will have high HIV viral loads despite taking anti-HIV drugs.

Timeline

Start

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Primary completion

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Completion

2005-07

Publications

• Background Saah AJ, Winchell GA, Nessly ML, Seniuk MA, Rhodes RR, Deutsch PJ. Pharmacokinetic profile and tolerability of indinavir-ritonavir combinations in healthy volunteers. Antimicrob Agents Chemother. 2001 Oct;45(10):2710-5. doi: 10.1128/AAC.45.10.2710-2715.2001.
• Background van Rossum AM, de Groot R, Hartwig NG, Weemaes CM, Head S, Burger DM. Pharmacokinetics of indinavir and low-dose ritonavir in children with HIV-1 infection. AIDS. 2000 Sep 29;14(14):2209-10. doi: 10.1097/00002030-200009290-00022. No abstract available.
• Background Chadwick EG, Rodman JH, Samson P, Fenton T, Abrams EJ, Nowak B, Pelton SI, Lavoie S, Knapp K, Bambji M, Yogev R, PACTG 1013 Team. Antiviral Activity, Tolerance and Pharmacokinetics of Indinavir with Two Doses of Ritonavir as Salvage Therapy in Children. 10th Conference on Retroviruses and Oppurtunistic Infections. Feb 2003. Abstract 875.

Drugs

Indications