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ALternative TEnofovir Dosing in Adults With Moderate Renal Function Impairment

NCT01671982 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-10-31

No results posted yet for this study

Summary

To assess the drug concentrations of tenofovir (TDF) in HIV-infected Thai adults with moderate renal function impairment when administered at the recommended dose of 300 mg every 48 hours, and at an alternative dose of 150 mg every 24 hours.

Conditions

Interventions

OTHER

Tenofovir Dose Adjustment

In subjects with a confirmed CLcr 30 to \<50 mL/min, switch tenofovir 300 mg every 48 hours, to 150 mg once daily for 2 weeks.

Sponsors & Collaborators

  • The Government Pharmaceutical Organization

    collaborator OTHER_GOV

  • Chiang Mai University

    collaborator OTHER

  • Institut de Recherche pour le Developpement

    lead OTHER_GOV

Principal Investigators

  • Tim R Cressey, PhD · PHPT / Chiang Mai University / IRD

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2014-01-31
Completion
2015-05-31

Countries

  • Thailand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01671982 on ClinicalTrials.gov