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Antiretroviral Therapy

Biktarvy After Kidney Transplant for HIV

Phase 4

Waitlist Available

Led By Catherine B Small, MD

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Received a previous renal transplant

At least 18 years old on day of signing informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 4, week 12, week 24, week 36, week 48, 3 month follow up, 6 month follow up

Awards & highlights

Study Summary

This trial will test a new HIV drug, Biktarvy, to see if it is safe and effective. People with HIV who have had a kidney transplant will be switched from their current medication to Biktarvy. The trial will last 48 weeks.

Who is the study for?

This trial is for adults over 18 with HIV who have had a kidney transplant and controlled their infection for at least 3 months. It's not for those already on Biktarvy, with allergies to its components, taking certain drugs like dofetilide or rifampin, or if they are pregnant/breastfeeding.Check my eligibility

What is being tested?

The study tests switching HIV patients post-kidney transplant to Biktarvy—a single tablet regimen—monitoring its effectiveness and safety over 48 weeks. The goal is to reduce the number of pills these patients take daily.See study design

What are the potential side effects?

While specific side effects aren't listed here, common ones associated with Biktarvy may include headache, diarrhea, nausea, fatigue and potential drug interactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had a kidney transplant.

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I am at least 18 years old.

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I am HIV positive.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 4, week 12, week 24, week 36, week 48, 3 month follow up, 6 month follow up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 4, week 12, week 24, week 36, week 48, 3 month follow up, 6 month follow up

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 4, week 12, week 24, week 36, week 48, 3 month follow up, 6 month follow up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in interaction between plasma concentrations for Bictegravir/Emtricitabine/Tenofovir alafenamide, intracellular TAF levels, tacrolimus levels, and renal function

Change in tolerated dose of Biktarvy in HIV positive post renal transplant participants as measured by HIV Treatment Satisfaction Questionnaire

Proportion of subjects with plasma HIV-1 RNA <50 copies/ml

+1 more

Secondary outcome measures

Change from baseline in CD4+ T lymphocyte cell count/percentages post renal transplant

Change in participants satisfaction with reduced pill burden, as measured by the health-related quality of life questionnaire

Correlation between rejection rates of the kidney transplant post renal and Tacrolimus levels

Trial Design

1Treatment groups

Experimental Treatment

Group I: BiktarvyExperimental Treatment1 Intervention

Participants receive a Biktarvy tablet orally once daily with or without food.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor

1,059 Previous Clinical Trials

1,316,123 Total Patients Enrolled

Gilead SciencesIndustry Sponsor

1,085 Previous Clinical Trials

848,125 Total Patients Enrolled

Catherine B Small, MDPrincipal InvestigatorWeill Medical College of Cornell University

Media Library

BIKTARVY 50Mg-200Mg-25Mg Tablet (Antiretroviral Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04530630 — Phase 4

Human Immunodeficiency Virus Infection Research Study Groups: Biktarvy

Human Immunodeficiency Virus Infection Clinical Trial 2023: BIKTARVY 50Mg-200Mg-25Mg Tablet Highlights & Side Effects. Trial Name: NCT04530630 — Phase 4

BIKTARVY 50Mg-200Mg-25Mg Tablet (Antiretroviral Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04530630 — Phase 4

~1 spots leftby Aug 2024

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