ALternative TEnofovir Dosing in Adults With Moderate Renal Function Impairment (ALTER)
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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 | Intervention | Phase |
---|---|---|
HIV |
Other: Tenofovir Dose Adjustment |
Phase 1 |
Study Type: | Interventional |
Study Design: | Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Official Title: | Tenofovir Pharmacokinetics in HIV-infected Thai Adults With Moderate Renal Function Impairment Receiving Either Efavirenz-based or Lopinavir/Ritonavir-based Antiretroviral Therapy |
- Tenofovir plasma area-under the concentration time curve (AUC) [ Time Frame: Study Entry and Day 14 ] [ Designated as safety issue: No ]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.
Estimated Enrollment: | 40 |
Study Start Date: | August 2012 |
Estimated Study Completion Date: | August 2013 |
Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
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.
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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 efavirenz (EFV)-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 efavirenz ,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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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 efavirenz, 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
Contact: Tim R Cressey, PhD | +66 53 894994 | tim.cressey@phpt.org |
Contact: Gonzague Jourdain, MD, PhD | +66 5381 9125 | Gonzague.Jourdain@phpt.org |
Thailand | |
Sanpatong Hospital | Recruiting |
Sanpatong, Chiang Mai, Thailand, 20120 | |
Contact: Virat Klinbuayaem, MD kggvirat@hotmail.com | |
Principal Investigator: Virat Klinbuayaem, MD | |
HIV-NAT | Not yet recruiting |
Bangkok, Thailand, 10330 | |
Contact: Anchalee Avihingsanon, MD 02-652-3040 anchalee.a@hivnat.org | |
Principal Investigator: Anchalee Avihingsanon, MD | |
Chonburi Hospital | Recruiting |
Chonburi, Thailand, 20000 | |
Contact: Chureeratana Bowonwatanuwong, MD 03893 1000 cbowon@gmail.com | |
Principal Investigator: Chureeratana Bowonwatanuwong, MD | |
Phayao Hospital | Recruiting |
Phayao, Thailand, 56000 | |
Contact: Guttiga Halue, MD drgutti@gmail.com | |
Principal Investigator: Guttiga Halue, MD |
Principal Investigator: | Tim R Cressey, PhD | PHPT / Chiang Mai University / IRD |
Additional Information:
No publications provided
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 |
Study First Received: | August 17, 2012 |
Last Updated: | February 19, 2013 |
Health Authority: | Thailand: Ministry of Public Health |
Additional relevant MeSH terms:
Tenofovir Tenofovir disoproxil Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents |
ClinicalTrials.gov processed this record on March 10, 2013