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

Timeline

Start

2025-08-14

Primary completion

2027-09-30

Completion

2028-03-31

Publications

• Results Adedeji WA, Ma Q, Raji AM, Cha R, Rasaki OM, Hutson A, Taiwo BO, Charurat ME, Yusuf OB, Fehintola FA, Gureje O, Morse GD. Prevalence of depression among people living with HIV in rural hospitals in South-Western Nigeria-Association with clinico-demographic factors. AIDS Res Ther. 2023 Dec 16;20(1):89. doi: 10.1186/s12981-023-00586-0.
• Results Borghetti A, Calcagno A, Lombardi F, Cusato J, Belmonti S, D'Avolio A, Ciccarelli N, La Monica S, Colafigli M, Delle Donne V, De Marco R, Tamburrini E, Visconti E, Di Perri G, De Luca A, Bonora S, Di Giambenedetto S. SLC22A2 variants and dolutegravir levels correlate with psychiatric symptoms in persons with HIV. J Antimicrob Chemother. 2019 Apr 1;74(4):1035-1043. doi: 10.1093/jac/dky508.
• Results Charlier C, Broly F, Lhermitte M, Pinto E, Ansseau M, Plomteux G. Polymorphisms in the CYP 2D6 gene: association with plasma concentrations of fluoxetine and paroxetine. Ther Drug Monit. 2003 Dec;25(6):738-42. doi: 10.1097/00007691-200312000-00014.
• Results Reese MJ, Savina PM, Generaux GT, Tracey H, Humphreys JE, Kanaoka E, Webster LO, Harmon KA, Clarke JD, Polli JW. In vitro investigations into the roles of drug transporters and metabolizing enzymes in the disposition and drug interactions of dolutegravir, a HIV integrase inhibitor. Drug Metab Dispos. 2013 Feb;41(2):353-61. doi: 10.1124/dmd.112.048918. Epub 2012 Nov 6.
• Results Wagner GJ, Maguen S, Rabkin JG. Ethnic differences in response to fluoxetine in a controlled trial with depressed HIV-positive patients. Psychiatr Serv. 1998 Feb;49(2):239-40. doi: 10.1176/ps.49.2.239.
• Results Yagura H, Watanabe D, Kushida H, Tomishima K, Togami H, Hirano A, Takahashi M, Hirota K, Ikuma M, Kasai D, Nishida Y, Yoshino M, Yamazaki K, Uehira T, Shirasaka T. Impact of UGT1A1 gene polymorphisms on plasma dolutegravir trough concentrations and neuropsychiatric adverse events in Japanese individuals infected with HIV-1. BMC Infect Dis. 2017 Sep 16;17(1):622. doi: 10.1186/s12879-017-2717-x.
• Results Fettiplace A, Stainsby C, Winston A, Givens N, Puccini S, Vannappagari V, Hsu R, Fusco J, Quercia R, Aboud M, Curtis L. Psychiatric Symptoms in Patients Receiving Dolutegravir. J Acquir Immune Defic Syndr. 2017 Apr 1;74(4):423-431. doi: 10.1097/QAI.0000000000001269.
• Results Eshun-Wilson I, Siegfried N, Akena DH, Stein DJ, Obuku EA, Joska JA. Antidepressants for depression in adults with HIV infection. Cochrane Database Syst Rev. 2018 Jan 22;1(1):CD008525. doi: 10.1002/14651858.CD008525.pub3.
• Results Lofgren SM, Nakasujja N, Boulware DR. Systematic Review of Interventions for Depression for People Living with HIV in Africa. AIDS Behav. 2018 Jan;22(1):1-8. doi: 10.1007/s10461-017-1906-3.
• Results Kumar V, Encinosa W. Effects of HIV Medication Complexity and Depression on Adherence to HIV Medication. Patient. 2010 Mar 1;3(1):59-69. doi: 10.2165/11531090-000000000-00000.
• Results Egbe CO, Dakum PS, Ekong E, Kohrt BA, Minto JG, Ticao CJ. Depression, suicidality, and alcohol use disorder among people living with HIV/AIDS in Nigeria. BMC Public Health. 2017 Jun 2;17(1):542. doi: 10.1186/s12889-017-4467-5.
• Results Obadeji A, O Ogunlesi A, O Adebowale T. Prevalence and Predictors of Depression in People living with HIV/AIDS Attending an Outpatient Clinic in Nigeria. Iran J Psychiatry Behav Sci. 2014 Spring;8(1):26-31.
• Results Nakimuli-Mpungu E, Bass JK, Alexandre P, Mills EJ, Musisi S, Ram M, Katabira E, Nachega JB. Depression, alcohol use and adherence to antiretroviral therapy in sub-Saharan Africa: a systematic review. AIDS Behav. 2012 Nov;16(8):2101-18. doi: 10.1007/s10461-011-0087-8.
• Results Brown GR, Rundell JR, McManis SE, Kendall SN, Zachary R, Temoshok L. Prevalence of psychiatric disorders in early stages of HIV infection. Psychosom Med. 1992 Sep-Oct;54(5):588-601. doi: 10.1097/00006842-199209000-00006.
• Results Arseniou S, Arvaniti A, Samakouri M. HIV infection and depression. Psychiatry Clin Neurosci. 2014 Feb;68(2):96-109. doi: 10.1111/pcn.12097. Epub 2013 Oct 30.
• Results Satz P, Myers HF, Maj M, Fawzy F, Forney DL, Bing EG, Richardson MA, Janssen R. Depression, substance use, and sexual orientation as cofactors in HIV-1 infected men: cross-cultural comparisons. NIDA Res Monogr. 1997;172:130-55. No abstract available.

Drugs

Indications