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Influence of fluoxetine on the disposition kinetics of dolutegravir among people living with HIV with major depression in Nigeria

Award Number: K43TW011995
ORGANIZATION: FOGARTY INTERNATIONAL CENTER
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/02/2022
PERIOD OF PERFORMANCE END DATE: 06/30/2027

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Influence of fluoxetine on the disposition kinetics of dolutegravir among people living with HIV with major depression in Nigeria - Abstract This K43 appplication is being submitted to provide the environment for me to achieve my goal to become an independent physician/scientist investigator and a leader in the study of HIV clinical pharmacology and pharmacogenomics. To continue my progress towards this goal, I have developed a comprehenisive K43 mentored research training program that includes a a longitudinal clincal research project with nested pharmacokinetic drug interaction and pharmacogenomic studies that are based on a hypothesis that combining fluoxetine with dolutegravir-based combination HIV antiviral treatment will increase the plasma concentration of dolutegravir and toxicity. This drug interaction may result in poor medication adherence, suboptimal treatment of depression and inadequate viral suppression. I will investigate this hypothesis during my research project utilizing well-designed pharmacokinetic studies of fluoxetine and dolutegravir in people living with HIV (PLWH) with major depression in Nigeria. Depression is a common comorbidity and the most common neuropsychiatric disorder among PLWH. My long-term career research goal is to reduce the morbidity and mortality associated with HIV/AIDS through the optimization of dosing regimens in PLWH in low-medium income countries. My initial training has allowed me to make progress in developing clinical research skills. However, there are four important areas that I will emphasize during the K43 award period including; (1) Design, conduct, monitoring and management of a clinical trial, (2) Population pharmacokinetics and pharmacodynamics modeling, (3) Pharmacogenomics, and (4) Advanced statistical methods. The specific aims of the K43 research plan are: 1. To determine the pharmacologic factors that contribute to the safety and effectiveness of fluoxetine among depressed PLWH treated with dolutegravir-based antiretroviral therapy. 2. To determine the pharmacokinetics of dolutegravir and fluoxetine in adult PLWH with depression. 3. To determine the impact of pharmacogenomics on pharmacokinetics and clinical responses focusing on polymorphisms in metabolizing enzymes and transporters including UGT1A1, SLC22A2, ABCG2, CYP2D6 and CYP3A4. .


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $72,455 )
2025	2025	COLLEGE OF MEDICINE, UNIVERSITY OF IBADAN	UNIVERSITY COLLEGE HOSPITAL	IBADAN				NGA	International Research and Research Training	000	4	7/14/2025	NON-COMPETING CONTINUATION	$72,455
														Subtotal = $72,455

Issue Date FY: 2024 ( Subtotal = $71,729 )
2024	2024	COLLEGE OF MEDICINE, UNIVERSITY OF IBADAN	UNIVERSITY COLLEGE HOSPITAL	IBADAN				NGA	International Research and Research Training	000	3	7/5/2024	NON-COMPETING CONTINUATION	$71,729
														Subtotal = $71,729

Issue Date FY: 2023 ( Subtotal = $70,238 )
2023	2023	COLLEGE OF MEDICINE ,UNIVERSITY OF IBADAN	UNIVERSITY COLLEGE HOSPITAL	IBADAN				NGA	International Research and Research Training	001	2	6/30/2023	NON-COMPETING CONTINUATION	$70,238
2023	2022	COLLEGE OF MEDICINE ,UNIVERSITY OF IBADAN	UNIVERSITY COLLEGE HOSPITAL	IBADAN				NGA	International Research and Research Training	000	1	6/28/2023	NEW	$0
														Subtotal = $70,238

Issue Date FY: 2022 ( Subtotal = $69,460 )
2022	2022	COLLEGE OF MEDICINE ,UNIVERSITY OF IBADAN	UNIVERSITY COLLEGE HOSPITAL	IBADAN				NGA	International Research and Research Training	000	1	8/5/2022	NEW	$69,460
														Subtotal = $69,460

Grand Total All Awards = $283,882

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Influence of fluoxetine on the disposition kinetics of dolutegravir among people living with HIV with major depression in Nigeria

Award Number: K43TW011995

ORGANIZATION: FOGARTY INTERNATIONAL CENTER

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 08/02/2022

PERIOD OF PERFORMANCE END DATE: 06/30/2027

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