Disposition Kinetics of Dolutegravir Among People Living With HIV With Major Depression in Nigeria

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

Conditions

• Depression
• HIV

Interventions

DRUG

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..

BEHAVIORAL

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.

Sponsors & Collaborators

• Fogarty International Center of the National Institute of Health

  collaborator NIH

• State University of New York at Buffalo

  collaborator OTHER

• Roswell Park Cancer Institute

  collaborator OTHER

• College of Medicine University of Ibadan

  collaborator UNKNOWN

• University College Hospital, Ibadan, Nigeria

  collaborator UNKNOWN

• National Institute of Mental Health (NIMH)

  collaborator NIH

• University of Ibadan

  lead OTHER

Principal Investigators

• Waheed A Adedeji · College of Medicine, University of Ibadan, Nigeria

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-08-14

Primary Completion

2027-09-30

Completion

2028-03-31

Countries

• Nigeria

Study Locations