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

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

168

Participants

Timeline

Start Date

August 14, 2025

Primary Completion Date

September 30, 2027

Study Completion Date

March 31, 2028

Conditions
DepressionHIV
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.

Trial Locations (1)

200221

University College Hospital, Ibadan

All Listed Sponsors
collaborator

Fogarty International Center of the National Institute of Health

NIH

collaborator

State University of New York at Buffalo

OTHER

collaborator

Roswell Park Cancer Institute

OTHER

collaborator

College of Medicine University of Ibadan

UNKNOWN

collaborator

University College Hospital, Ibadan, Nigeria

UNKNOWN

collaborator

National Institute of Mental Health (NIMH)

NIH

lead

University of Ibadan

OTHER