Clinical Trials Logo

Clinical Trial Summary

A case control pharmacokinetic study evaluating the effects of atazanavir-ritonavir on the pharmacokinetics and toxicity of lumefantrine in people living with HIV attending APIN clinic of the Lagos University Teaching Hospital


Clinical Trial Description

Atazanavir-ritonavir (ATVr) based antiretroviral therapy and artemether-lumefantrine (AL) are commonly used drugs for the treatment of Human Immune Deficiency Virus (HIV) infection and malaria respectively in Nigeria. However, both drugs interact with Cytochrome P 3A4 (CYP 3A4) isoenzymes which may spawn clinically significant pharmacokinetic interactions.

The study was aimed at evaluating the effects of atazanavir-ritonavir on the pharmacokinetics and toxicity of lumefantrine.

In a case control pharmacokinetic study, twenty participants who tested positive for Plasmodium falciparum malaria were recruited and divided into two groups (ATVr-arm, n=10; and Control-arm, n= 10). All the participants were administered with 6 doses of AL 80-480 mg (Coartem). Thereafter, blood samples were collected from them at different time intervals over seven days. The lumefantrine concentration in each sample was determined with high-performance liquid chromatography (HPLC) and entered into WinNonlin® software to determine the pharmacokinetic parameters of lumefantrine which were compared between the test and control groups. Toxicity was evaluated with adverse events monitoring, electrocardiography, haematological and blood chemistry tests at pre and post doses of artemether-lumefantrine. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04531072
Study type Interventional
Source Fogarty International Center of the National Institute of Health
Contact
Status Completed
Phase Phase 4
Start date September 18, 2018
Completion date August 15, 2019

See also
  Status Clinical Trial Phase
Completed NCT04645940 - Fruquintinib Food Effect and Proton Pump Inhibitor Study Phase 1
Completed NCT04540965 - Impact of a Histamine H2 Receptor Antagonist (H2RA) on the Pharmacokinetics (PK) of Telaglenastat in Healthy Subjects Phase 1
Completed NCT03385525 - Study to Evaluate the Effect of UGT Inhibition by Valproic Acid on the Pharmacokinetics of BIIB074 Phase 1
Completed NCT05680792 - Pharmacokinetic Interaction Between Nitazoxanide and Atazanavir/Ritonavir in Healthy Volunteers N/A
Completed NCT05137548 - A Drug-Drug Interaction Study Between ATI-2173 and Tenofovir Disoproxil Fumarate in Healthy Subjects Phase 1
Not yet recruiting NCT05525351 - The Application and Validation of Triple Drug Response Surface Models on Density Spectral Array in Clinical Anesthesia
Terminated NCT01980342 - Pharmacokinetics and Pharmacodynamics of the Etonogestrel Contraceptive Implant When Co-administered With Efavirenz Phase 4
Completed NCT04080596 - DDI Study to Investigate the Impact of Itraconazole on the Pharmacokinetics of Dorzagliatin Phase 1
Recruiting NCT04593680 - Assessment of Drug-drug Interactions Between Masculinizing Hormone Therapy and Antiretroviral Agents Concomitantly for Pre-exposure Prophylaxis Among Transgender Men N/A
Active, not recruiting NCT04590417 - Assessment of Drug-drug Interactions Between Feminizing Hormone Therapy and Emtricitabine/Tenofovir Alafenamide Concomitantly for Pre-exposure Prophylaxis Among Transgender Women N/A
Completed NCT05633147 - Effect of Clarithromycin on PK of Linaprazan, Linaprazan on PK of Clarithromycin and Linaprazan on PK of Midazolam Phase 1
Completed NCT02391688 - Evaluation of the Potential Pharmacokinetic Interactions Between Probe Drugs in the Geneva Phenotyping Cocktail Phase 1
Completed NCT00806299 - Loperamide Grapefruit Juice Interaction PK Trial Phase 1
Completed NCT03336346 - Effect of Dolutegravir on Etonogestrel Levels in HIV-infected Women in Botswana
Completed NCT04818086 - Drug-drug Interaction Study of Lemborexant as an Adjunctive Treatment for Buprenorphine/Naloxone for Opioid Use Disorder Phase 1/Phase 2
Completed NCT03187015 - A Study to Examine the Effects of Entinostat on Midazolam in Healthy Adult Subjects Phase 1
Not yet recruiting NCT04463576 - Drug Interactions in Hospital Information System. The PRoSIT System..
Not yet recruiting NCT03920566 - The Effect of ENZAlutamide on the Anti-Xa Levels of Patients Receiving DOACs
Completed NCT03011996 - To Investigate PK and PD of CJ-12420, Clarithromycin, Amoxicillin After Multiple Dose Administration Phase 1
Completed NCT04902105 - Drug-Drug Interaction Study to Evaluate the Effect of Inhibition of UGTs on the PK of Ecopipam and Its Active Metabolite Phase 1