Testing fluoxetine with dolutegravir in people with HIV and depression
Tests fluoxetine alongside HIV drug dolutegravir in adults with HIV and depression.
Plain-language title generated from the registry record
Registry title: Disposition Kinetics of Dolutegravir Among People Living With HIV With Major Depression in Nigeria
Key facts
- Where
- Ibadan, NigeriaSee the site
- Phase
- Phase 4
Where in Nigeria
- University College HospitalIbadan, NigeriaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Ibadan
- Trial code
- NCT07110831
- Record updated
- 8 August 2025
- Original description
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).Read full original descriptionShow less
Influence of Fluoxetine on the Disposition Kinetics of Dolutegravir Among People Living With HIV With Major Depression in Nigeria
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
Inclusion: Males and females aged 18 years and above; Willing to provide informed consent; Confirmed HIV positive [HIV-seropositive by Enzyme Linked Immunosorbent Assay (ELISA) and Western Blot assays]; Willingness to receive and or continue anti-HIV therapy (DTG-based cART) \& adhere to follow-up schedule; Willing and able to comply with antidepressant medication(fluoxetine) regimen and scheduled follow-up visits; Current depressive symptoms [Subjects with depression (HAM-D-17 score ≥ 8)]; Adequate renal function (serum creatinine < 1.5mg/dl); Adequate liver function [aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤1.5 x Upper Limits of Normal).
Exclusion: Currently taking antipsychotic medication; Use of drugs other than cART, especially known enzyme inducers or inhibitors; Current substance use disorder; Presence of psychotic symptoms or known diagnosis of a primary psychotic disorder; Presence of symptoms of bipolar disorder; Current or chronic medical condition that would likely preclude adherence to protocol or completion of the trial (per investigator judgment); History of intolerance to study drug (fluoxetine); Abnormal ECG (e.g., prolonged QT interval); Imminent risk of suicide- Acute suicidal ideation, gestures, or attempts; Pregnant or willing to get pregnant or lactation; Antidepressants, mood stabilisers or other neuroleptics intake within three months.