Trial intelligence / Profile preview

Oral FIAC for CMV in AIDS

NCT00000981Phase 2

Key facts

Status: Completed
Countries: 1
Sponsor: National Institute of Allergy and Infectious Diseases
Modality: Orthosteric Ligands, Metabolically Activated Prodrugs

Drugs: fiacitabine
Conditions: cytomegalovirus infection (CMV)

Overview

Phase 2, open-label, single-arm trial of fiacitabine in cytomegalovirus infection (CMV), sponsored by National Institute of Allergy and Infectious Diseases. Primary endpoints: Efficacy in treating cytomegalovirus (CMV) viremia up to 90 days, Tolerance and safety of FIAC up to 90 days and 1 more. Status: completed.

Design

1 arm

Study design: Non-randomizedOpen-label

Fiacitabine Dose Escalation
Sequential cohorts receiving escalating doses of oral Fiacitabine.

Who it enrols

HIV-infected patients with documented CMV viremia or viruria, ambulatory, and able to take oral medication. Patients must not have CMV end organ disease or unstable medical conditions.

Endpoints

Primary

Efficacy in treating cytomegalovirus (CMV) viremiaup to 90 days
Tolerance and safety of FIACup to 90 days
Pharmacokinetics following multiple doses of FIACup to 90 days

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