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P1092

Phase IV Evaluation of the Steady State Pharmacokinetics of Zidovudine, Lamivudine, and Lopinavir/Ritonavir in Severely Malnourished HIV-1 Infected Children

Study Status

Participants Off Study and Primary Analysis Completed

DAIDS Number

11689

IND Number

Non-IND

Clinical Trials Link

Summary

P1092 is a Phase IV, multi-center, pharmacokinetic study of zidovudine (ZDV), lamivudine (3TC), and lopinavir/ritonavir (LPV/r) in severely malnourished HIV-infected children (ages 6 to < 36 months).  The study is designed to assess the pharmacokinetic exposure, safety, and tolerability of ZDV, 3TC, and LPV/r in severely malnourished children compared to children with normal nutrition.

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