A Phase I Study to Evaluate the Pharmacokinetics, Safety and Antiviral Effects of Concurrent Administration of Zidovudine (AZT) and 2'3'-Dideoxyinosine (ddI) in Patients With Human Immunodeficiency Virus (HIV)

Summary

To determine the safety and tolerance of various combinations of zidovudine (AZT) and didanosine (ddI) administered concurrently. To determine the pharmacokinetics of concurrent AZT and ddI administered orally. To evaluate the antiviral, immunologic and virologic effects of AZT and ddI administered concurrently.

Timeline

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Primary completion

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Completion

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Outcome

Missed primary endpoint

paper The primary endpoint of the study to increase the R0 resection rate in metabolic NR was not met. PMID 36099671 ↗

Publications

• Lorenzen S, Quante M, Rauscher I, Slotta-Huspenina J, Weichert W, Feith M, Friess H, Combs SE, Weber WA, Haller B, Angele M, Albertsmeier M, Blankenstein C, Kasper S, Schmid RM, Bassermann F, Schwaiger M, Liffers ST, Siveke JT. PET-directed combined modality therapy for gastroesophageal junction cancer: Results of the multicentre prospective MEMORI trial of the German Cancer Consortium (DKTK). Eur J Cancer. 2022 Nov;175:99-106. doi: 10.1016/j.ejca.2022.07.027. Epub 2022 Sep 10.

Drugs

Indications