Influence of Fluoxetine on the Disposition Kinetics of Dolutegravir Among People Living With HIV With Major Depression in Nigeria

Plain English Summary

Disposition Kinetics of Dolutegravir Among People Living With HIV With Major Depression in Nigeria is a Phase 4 clinical trial sponsored by University of Ibadan studying Depression, HIV. This study will see how well fluoxetine, a common antidepressant, works with dolutegravir, an HIV medication, in people with both conditions. It is for adults in Nigeria who are living with HIV and also experiencing depression. Participants will either take fluoxetine with talk therapy (CBT) or just talk therapy (CBT) for 3 months, with regular clinic visits and blood tests. Alternatives include standard depression treatment and HIV management without this specific drug combination study. The trial aims to enroll 168 participants.

Official 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

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults aged 18 and over who have been diagnosed with HIV and are currently experiencing depression. Individuals must be willing to take HIV medication (dolutegravir) and the study antidepressant (fluoxetine), and attend all appointments. People with severe kidney or liver problems, current substance use disorders, or a high risk of suicide cannot join. Pregnant or breastfeeding individuals, or those with bipolar disorder or psychotic symptoms, are also excluded. This trial is studying Depression, HIV, so participants generally need a confirmed diagnosis.

What They're Measuring

The study will measure how fluoxetine changes the amount of dolutegravir in the body, ensuring that the HIV medication remains effective while treating depression. The specific primary outcome measures are: Mean change in the Hamilton Depression Rating Scale (HAM-D) scores from baseline to 12 weeks (Baseline to the end of treatment at 12 weeks); Mean changes in the AUC of dolutegravir (Week 2 to the end of treatment at 12 weeks); Mean changes in the Cmax of doultegravir (Week 2 to the end of treatment at 12 weeks); Mean changes in the Cmin of dolutegravir (Week 2 to the end of treatment at 12 weeks); Mean changes in the AUC of fluoxetine (Week 2 to the end of treatment at 12 weeks). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This is a Phase 4 (post-marketing) study of a treatment that has already received FDA approval. Phase 4 trials monitor long-term safety, effectiveness in broader patient populations, and potential interactions with other treatments in real-world settings. These studies can involve thousands of patients and help identify rare side effects that may not have appeared in earlier, smaller trials.

Why This Trial Matters

This trial is important because it addresses the common co-occurrence of depression in people with HIV, aiming to ensure that effective depression treatment does not negatively impact HIV therapy. This research targets Depression, HIV, where improved treatment options are needed.

Investor Insight

This trial focuses on a specific patient population in Nigeria, indicating a need for localized research on drug interactions for HIV and depression treatment, with potential implications for global t This treatment is already approved and on the market. This post-marketing study monitors real-world outcomes.

Is This Trial Right for Me?

Ask your doctor if fluoxetine and dolutegravir are right for you and what side effects to watch for. You will need to attend weekly clinic visits for the first month, then every two weeks, and may have blood tests. You will be asked to keep a diary of your symptoms and any other issues you experience. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NON_RANDOMIZED
• Model: PARALLEL
• Masking: SINGLE
• Enrollment: 168 participants

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.

Primary Outcomes

• Mean change in the Hamilton Depression Rating Scale (HAM-D) scores from baseline to 12 weeks (Baseline to the end of treatment at 12 weeks)
• Mean changes in the AUC of dolutegravir (Week 2 to the end of treatment at 12 weeks)
• Mean changes in the Cmax of doultegravir (Week 2 to the end of treatment at 12 weeks)
• Mean changes in the Cmin of dolutegravir (Week 2 to the end of treatment at 12 weeks)
• Mean changes in the AUC of fluoxetine (Week 2 to the end of treatment at 12 weeks)

Secondary Outcomes

• Proportion of participants reporting grade 3 or 4 Adverse Events as Assessed by the DAIDS AE Grading Table Corrected Version 2.1 (Baseline to weeks 2, 4, 8, and 12)
• Proportion of participants with depression remission at week 12 (Baseline to the end of treatment at 12 weeks)
• Proportion of participants with a change of greater than or equal to (≥) 50% in the depression score from baseline to weeks 6, 8, and 12 (Baseline to weeks 6, 8 and 12)
• Proportion of participants that drop out (study dropouts) during the study (Baseline to weeks 2, 4, 6, 8, and 12)
• Proportion of participants with viral suppression (≤ 50 copies/mL) (Baseline to the end of study at week 12)

Full Eligibility Criteria

Inclusion Criteria:

* 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 Criteria:

* Current substance use disorder
* Imminent risk of suicide- Acute suicidal ideation, gestures, or attempts
* Presence of psychotic symptoms or known diagnosis of a primary psychotic disorder
* Presence of symptoms of bipolar disorder
* Currently taking antipsychotic medication
* Pregnant or willing to get pregnant or lactation
* Current or chronic medical condition that would likely preclude adherence to protocol or completion of the trial (per investigator judgment)
* Antidepressants, mood stabilisers or other neuroleptics intake within three months
* Use of drugs other than cART, especially known enzyme inducers or inhibitors
* Abnormal ECG (e.g., prolonged QT interval)
* History of intolerance to study drug (fluoxetine)

Trial Locations

• University College Hospital, Ibadan, Oyo State, Nigeria

Frequently Asked Questions

Related Conditions

• Depression
• HIV Infections
• Major Depressive Disorder
• Antiretroviral Therapy
• Psychiatric Comorbidity
• Drug Interactions
• Pharmacokinetics
• Mental Health
• Infectious Diseases
• Pharmacology

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