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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

Must not have

Currently taking Biktarvy for treatment of HIV

Currently taking dofetilide or rifampin

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

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently being treated with Biktarvy for HIV.

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I am currently taking dofetilide or rifampin.

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I am allergic to one or more drugs in Biktarvy.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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