Drug Interaction Clinical Trial
Official title:
Effect of Atazanavir-ritonavir on the Pharmacokinetics and Toxicity of Lumefantrine in People Living With HIV Attending Lagos University Teaching Hospital
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
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.
;
| 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 |