NCT01671982

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 hiv

Timeline
Completed

Started Aug 2012

Longer than P75 for phase_1 hiv

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 24, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

October 31, 2023

Status Verified

October 1, 2023

Enrollment Period

1.4 years

First QC Date

August 17, 2012

Last Update Submit

October 29, 2023

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

  • Tenofovir plasma area-under the concentration time curve (AUC)

    For each patient, ratios of AUC0-last of q24h versus q48h will be calculated. Geometric mean ratios (GMRs) with 90% CI will be calculated after log-transformation of within patient ratios.

    Study Entry and Day 14

Study Arms (1)

Tenofovir-containing HAART

EXPERIMENTAL
Other: Tenofovir Dose Adjustment

Interventions

Tenofovir Dose AdjustmentOTHER

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.

Tenofovir-containing HAART

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age \>18 years old
  • provided written informed consent
  • receiving the tenofovir tablet formulation from the Thai Government Pharmaceutical Organization (GPO) for at least 4 weeks before enrollment
  • documentation of confirmed HIV-1 infection (documented by two serology tests obtained at two different dates)
  • Confirmed Creatinine clearance result between 30 to \<50 mL/min \[confirmed defined as two CLcr determinations calculated using the Cockcroft-Gault equation within two weeks of each other, within 1 month prior to entry\]
  • received tenofovir 300 mg, every 48 hours for at least 2 weeks prior to entry, in combination with 3TC plus NNRTI, or 3TC plus lopinavir/ritonavir
  • a HIV-1 RNA viral load \< 50 copies/mL within 6 months prior to entry

You may not qualify if:

  • Concomitant use of a atazanavir, didanosine
  • Pregnant
  • Any of the following laboratory tests within 30 days prior to study entry classified as ≥ Grade 3 (see DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0 \[Dec. 2004\], Clarification August, 2009): neutrophil count, hemoglobin, platelets, AST, or ALT
  • HBs-antigen positive
  • Any clinically significant diseases (other than HIV-1 infection) or clinically significant findings during the screening medical history or physical examination that, in the investigator's opinion, would compromise participation in this study
  • concurrent participation to any other clinical trial without prior agreement of the two study teams

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Chonburi Hospital

Chon Buri, Changwat Chon Buri, 20000, Thailand

Location

Sanpatong Hospital

Sanpatong, Chiang Mai, 20120, Thailand

Location

HIV-NAT

Bangkok, 10330, Thailand

Location

Nakornping Hospital

Chiang Mai, Thailand

Location

Phayao Hospital

Phayao, 56000, Thailand

Location

Related Publications (1)

  • Cressey TR, Avihingsanon A, Halue G, Leenasirimakul P, Sukrakanchana PO, Tawon Y, Jaisieng N, Jourdain G, Podany AT, Fletcher CV, Klinbuayaem V, Bowonwatanuwong C. Plasma and Intracellular Pharmacokinetics of Tenofovir Disoproxil Fumarate 300 mg Every 48 Hours vs 150 mg Once Daily in HIV-Infected Adults With Moderate Renal Function Impairment. Clin Infect Dis. 2015 Aug 15;61(4):633-9. doi: 10.1093/cid/civ346. Epub 2015 Apr 28.

    PMID: 25921689RESULT

Related Links

Study Officials

  • Tim R Cressey, PhD

    PHPT / Chiang Mai University / IRD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

August 17, 2012

First Posted

August 24, 2012

Study Start

August 1, 2012

Primary Completion

January 1, 2014

Study Completion

May 1, 2015

Last Updated

October 31, 2023

Record last verified: 2023-10

Locations

TH(5)