Evaluation of Effect of Renal Impairment on the PK of Tenofovir Exalidex
NCT03284164 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16
Last updated 2018-06-06
Summary
This is a Phase 1 study to investigate the effects of Renal Impairment on the pharmacokinetics of Tenofovir exalidex
Conditions
- Renal Impairment
Interventions
- DRUG
-
Tenofovir Exalidex (TXL)
Drug: Tenofovir Exalidex (TXL)
Sponsors & Collaborators
-
ContraVir Pharmaceuticals, Inc.
lead INDUSTRY
Principal Investigators
-
John Sullivan-Bolyai, MD, MPH · ContraVir Pharmaceuticals
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-09-28
- Primary Completion
- 2018-01-17
- Completion
- 2018-02-20
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Tenofovir Renal Toxicity and Glomerular Filtration Rate (GFR) Validation
NCT01138241 ·Status: COMPLETED
-
Assessing Virologic Success and Metabolic Changes in Patients Switching From a TDF to TAF Containing Antiretroviral Therapy Regimen
NCT03646370 ·Status: COMPLETED
-
Pharmacokinetics of Islatravir in Participants With Severe Renal Impairment (MK-8591-026)
NCT04303156 ·Status: COMPLETED ·Phase: PHASE1
-
Cobicistat-containing Highly Active Antiretroviral Regimens in HIV-1 Infected Patients With Mild to Moderate Renal Impairment
NCT01363011 ·Status: COMPLETED ·Phase: PHASE3
-
ALternative TEnofovir Dosing in Adults With Moderate Renal Function Impairment
NCT01671982 ·Status: COMPLETED ·Phase: PHASE1
-
Long-term Study in Patients Under Anti-retroviral Combination Therapy Switching to Viramune®
NCT02191293 ·Status: COMPLETED
-
Metabolic Impact Assessment of Tenofovir Disoproxil Fumarate on Non-HIV-1 Infected Healthy Adult Male Volunteers
NCT00648817 ·Status: COMPLETED ·Phase: PHASE4
-
The Lighthouse Tenofovir Cohort Study
NCT02381275 ·Status: UNKNOWN
-
Renal Effect of Stribild or Other Tenofovir DF-containing Regimens Compared to Ritonavir-boosted Atazanavir Plus Abacavir/Lamivudine in Antiretroviral Treatment-naive HIV-1 Infected Adults
NCT02246998 ·Status: COMPLETED ·Phase: PHASE4
-
Tenofovir Disoproxil Fumarate (TDF) in HIV-1 Patients Who Have Never Taken Anti-HIV Drugs
NCT00016588 ·Status: COMPLETED ·Phase: NA
-
TAF for HIV-HBV With Renal Dysfunction
NCT03115736 ·Status: COMPLETED ·Phase: PHASE2
-
Examining Hair to Determine Tenofovir Exposure
NCT00903084 ·Status: COMPLETED ·Phase: PHASE1
-
A Clinical Trial Comparing the Efficacy of Tenofovir Disoproxil Fumarate/Emtricitabine/Rilpivirine (TDF/FTC/RPV) Versus TDF/FTC/Efavirenz (TDF/FTC/EFV) in Patients With Undetectable Plasma HIV-1 RNA on Current First-line Treatment
NCT01709084 ·Status: COMPLETED ·Phase: PHASE3
-
Pilot Study of Raltegravir Switch to Resolve Tenofovir Induced Proteinuria
NCT01044771 ·Status: COMPLETED ·Phase: NA
-
Observational Study With Antiretroviral Treated Patients Switching to Nevirapine Plus Two Nucleoside Reverse Transcriptase Inhibitor (NRTI) Regimens
NCT02191319 ·Status: COMPLETED
-
Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284)
NCT02116660 ·Status: TERMINATED ·Phase: PHASE2
-
Pharmacokinetics Study of GSK1265744 in Subjects With Severe Renal Impairment
NCT02354937 ·Status: COMPLETED ·Phase: PHASE1
-
Bangkok Tenofovir Study, an HIV Pre-exposure Prophylaxis Trial, Bangkok, Thailand
NCT00119106 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
TNX-355 With Optimized Background Therapy (OBT) in Treatment-Experienced Subjects With HIV-1
NCT00089700 ·Status: UNKNOWN ·Phase: PHASE2
-
Study Comparing Reducing the Dose of Stavudine Versus Switching to Tenofovir in HIV-Infected Patients Receiving Antiretroviral Therapy
NCT00312832 ·Status: COMPLETED ·Phase: NA
-
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of E/C/F/TAF Fixed Dose Combination (FDC) in HIV-1 Infected Adults on Chronic Hemodialysis
NCT02600819 ·Status: COMPLETED ·Phase: PHASE3
-
Phase 3 Open-Label Study to Evaluate Switching From Optimized Stable Antiretroviral Regimens Containing Darunavir to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) Plus Darunavir (DRV) in Treatment Experienced HIV-1 Positive Adults
NCT01968551 ·Status: COMPLETED ·Phase: PHASE3
-
Measurement of Plasma and Intracellular Concentrations of Raltegravir
NCT01214486 ·Status: COMPLETED ·Phase: NA
-
Tenofovir Disoproxil Fumarate in HIV-Infected Patients Who Have Not Had Success With Other Anti-HIV Drug Combinations
NCT00011089 ·Status: UNKNOWN ·Phase: NA
-
Once-daily Antiretroviral Therapy in HIV-1 Infected Patients With CD4+ Cell Counts Below 100 Cells/Mcl
NCT00532168 ·Status: COMPLETED ·Phase: PHASE4