K43TW011995
Project Grant
Overview
Grant Description
Influence of fluoxetine on the disposition kinetics of dolutegravir among people living with HIV with major depression in Nigeria - Abstract
This K43 application 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 comprehensive K43 mentored research training program that includes a longitudinal clinical 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.
This K43 application 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 comprehensive K43 mentored research training program that includes a longitudinal clinical 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.
Funding Goals
THE JOHN E. FOGARTY INTERNATIONAL CENTER (FIC) SUPPORTS RESEARCH AND RESEARCH TRAINING TO REDUCE DISPARITIES IN GLOBAL HEALTH AND TO FOSTER PARTNERSHIPS BETWEEN U.S. SCIENTISTS AND THEIR COUNTERPARTS ABROAD. FIC SUPPORTS BASIC BIOLOGICAL, BEHAVIORAL, AND SOCIAL SCIENCE RESEARCH, AS WELL AS RELATED RESEARCH TRAINING AND CAREER DEVELOPMENT. THE RESEARCH PORTFOLIO IS DIVIDED INTO SEVERAL PROGRAMS THAT SUPPORT A WIDE VARIETY OF FUNDING MECHANISMS TO MEET PROGRAMMATIC OBJECTIVES.
Grant Program (CFDA)
Awarding Agency
Funding Agency
Place of Performance
Nigeria
Geographic Scope
Foreign
Related Opportunity
Analysis Notes
Amendment Since initial award the total obligations have increased 468% from $50,000 to $283,882.
niversity Of Ibadan College Of Medicine was awarded
Fluoxetine's Influence on Dolutegravir in HIV+ with Depression
Project Grant K43TW011995
worth $283,882
from the National Institute of Mental Health in August 2022 with work to be completed primarily in Nigeria.
The grant
has a duration of 4 years 10 months and
was awarded through assistance program 93.242 Mental Health Research Grants.
The Project Grant was awarded through grant opportunity Emerging Global Leader Award (K43 Independent Clinical Trial Required).
Status
(Ongoing)
Last Modified 7/21/25
Period of Performance
8/2/22
Start Date
6/30/27
End Date
Funding Split
$283.9K
Federal Obligation
$0.0
Non-Federal Obligation
$283.9K
Total Obligated
Activity Timeline
Transaction History
Modifications to K43TW011995
Additional Detail
Award ID FAIN
K43TW011995
SAI Number
K43TW011995-2583856801
Award ID URI
SAI UNAVAILABLE
Awardee Classifications
Non-Domestic (Non-U.S.) Entity
Awarding Office
75NF00 NIH Fogarty International Center
Funding Office
75N700 NIH National Institute of Mental Health
Awardee UEI
REY7Z9C2K9F9
Awardee CAGE
SCL10
Performance District
Not Applicable
Budget Funding
| Federal Account | Budget Subfunction | Object Class | Total | Percentage |
|---|---|---|---|---|
| National Institute of Mental Health, National Institutes of Health, Health and Human Services (075-0892) | Health research and training | Grants, subsidies, and contributions (41.0) | $100,000 | 72% |
| John E. Fogarty International Center, National Institutes of Health, Health and Human Services (075-0819) | Health research and training | Grants, subsidies, and contributions (41.0) | $39,698 | 28% |
Modified: 7/21/25