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Disposition Kinetics of Dolutegravir Among People Living With HIV With Major Depression in Nigeria
Sponsor: University of Ibadan
Summary
The goal of this clinical trial is to find out the usefulness and well-being of people when drugs for treating depression (fluoxetine) and HIV (dolutegravir) are used together. It will also learn about how safe it is to take fluoxetine and dolutegravir together by the people living with HIV (PLWH). The main questions it aims to answer are: * Does fluoxetine (antidepressant) make participants taking anti-HIV (dolutegravir) feel better? * What medical problems do participants have when taking fluoxetine and dolutegravir together? * Does what people inherit from their parents affect the effectiveness and medical problems that participants have when taking fluoxetine and dolutegravir together? Researchers will compare depression treatments, fluoxetine and psychological treatment \[cognitive behavioural therapy (CBT)\] together to psychological treatment (CBT) alone among adults PLWH on anti-HIV drug (dolutegravir). Participants on anti-HIV dolutegravir having depression will: * Take both fluoxetine (daily) and CBT together or CBT alone for 3 months * Visit the clinic once every week in the first month, then once every 2 weeks for checkups and tests including blood tests * Keep a diary of their symptoms and other complaints
Official title: Influence of Fluoxetine on the Disposition Kinetics of Dolutegravir Among People Living With HIV With Major Depression in Nigeria
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
168
Start Date
2025-08-14
Completion Date
2028-03-31
Last Updated
2025-08-08
Healthy Volunteers
No
Conditions
Interventions
Fluoxetine
Participants in the intervention arm will receive oral fluoxetine capsules starting with 20mg daily for 12 weeks. The dose of the fluoxetine may be adjusted during follow-up by titrating the dose against the participants' response..
Cognitive-behavioral therapy
Participants with HAM-D score of between 8 and 13 (mild depression) will receive sessions of Cognitive Behavioural Therapy (CBT) as per standard routine care. Participants in the intervention arm will also receive sessions of CBT as per standard routine care.
Locations (1)
University College Hospital
Ibadan, Oyo State, Nigeria