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ALternative TEnofovir Dosing in Adults With Moderate Renal Function Impairment (ALTER)

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ClinicalTrials.gov Identifier: NCT01671982
Recruitment Status : Completed
First Posted : August 24, 2012
Last Update Posted : May 29, 2015
Sponsor:
Collaborators:
The Government Pharmaceutical Organization
Chiang Mai University
Information provided by (Responsible Party):
Gonzague Jourdain, Institut de Recherche pour le Developpement

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.

Condition or disease Intervention/treatment Phase
HIV Other: Tenofovir Dose Adjustment Phase 1

Detailed Description:

The study is designed as a Phase I, non-randomized, open-label, pharmacokinetic study. We hypothesize that administration of tenofovir 150 mg once daily to HIV-infected Thai adults with moderate renal function impairment (CLcr between 30 to <50 mL/min) will provide comparable drug exposure to the current recommended dose of 300 mg every 48 hours.

Confirmed HIV-positive subjects receiving tenofovir (TDF) 300 mg, every 48 hours, as part of an NNRTI-based or lopinavir/ritonavir (LPV/r)-based HAART regimen will be proposed to participate.

Subjects meeting the required criteria will be enrolled into one of 2 groups depending on their HAART regimen: .

Group 1: Subjects receiving tenofovir 300 mg, every 48 hours, in combination with lamivudine and an NNRTI,and a confirmed CLcr 30 to <50 mL/min

Group 2: Subjects receiving tenofovir 300 mg, every 48 hours, in combination with lamivudine and lopinavir/ritonavir, and a confirmed CLcr 30 to <50 mL/min

The study procedures are identical for both groups. All subjects enrolled will have two study visits. At the first visit, a 48-hour pharmacokinetic evaluation will be performed. Immediately following completion of the PK sampling, the tenofovir dose will be changed to 150 mg, once daily. Two weeks later, at the second visit, a 24-hour pharmacokinetic evaluation will be performed. Following completion of the second PK sampling the tenofovir dose will be changed back to 300 mg every 48 hours. At this time the subjects has reach the end of the study.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tenofovir Pharmacokinetics in HIV-infected Thai Adults With Moderate Renal Function Impairment Receiving Either a Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI)-Based or Lopinavir/Ritonavir-based Antiretroviral Therapy
Study Start Date : August 2012
Primary Completion Date : January 2014
Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Tenofovir-containing HAART 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.



Primary Outcome Measures :
  1. Tenofovir plasma area-under the concentration time curve (AUC) [ Time Frame: Study Entry and Day 14 ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01671982


Locations
Thailand
Sanpatong Hospital
Sanpatong, Chiang Mai, Thailand, 20120
HIV-NAT
Bangkok, Thailand, 10330
Nakornping Hospital
Chiang Mai, Thailand
Chonburi Hospital
Chonburi, Thailand, 20000
Phayao Hospital
Phayao, Thailand, 56000
Sponsors and Collaborators
Institut de Recherche pour le Developpement
The Government Pharmaceutical Organization
Chiang Mai University
Investigators
Principal Investigator: Tim R Cressey, PhD PHPT / Chiang Mai University / IRD

Additional Information:
Publications:
Responsible Party: Gonzague Jourdain, Director, International Reserach Unit 174, Institut de Recherche pour le Developpement
ClinicalTrials.gov Identifier: NCT01671982     History of Changes
Other Study ID Numbers: ALTER
First Posted: August 24, 2012    Key Record Dates
Last Update Posted: May 29, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Tenofovir
Reverse Transcriptase Inhibitors
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents