NCT07110831Not yet recruitingPhase 4
Disposition Kinetics of Dolutegravir Among People Living With HIV With Major Depression in Nigeria
Influence of Fluoxetine on the Disposition Kinetics of Dolutegravir Among People Living With HIV With Major Depression in Nigeria
Source: ClinicalTrials.gov · Last updated 8 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 168 (estimated)
- First submitted
- 15 May 2025
- Start date
- 14 Aug 2025
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- University of Ibadan
- Diseases
- Depression, HIV
- NCT number
- NCT07110831
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 168
- From 14 Aug 2025 to the primary completion date, 30 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently taking antipsychotic medication
- Use of drugs other than cART, especially known enzyme inducers or inhibitors
Other illness
- 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)
Lab values
- Abnormal ECG (e.g., prolonged QT interval)
Other
- 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
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University College Hospital Coordinator of this site? Confirm its status | Ibadan | Nigeria | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.