Testing the Safety and Efficacy of Commercial Drug Biktarvy in Subjects Known to Have the 184 Resistance Mutation to a Component in Biktarvy

Open-label Switch Study From a Regimen of Elvitegravir/Tenofovir Alafenamide/Emtricitabine/Cobicistat and Darunavir, to a FDC of Bictegravir/Tenofovir Alafenamide/Emtricitabine in Virologically Suppressed HIV-l Subjects Known to Have an 184 V/I Mutation

An Open-Label Study to Evaluate Switching from a Regimen of Elvitegravir/Tenofovir alafenamide/Emtricitabine/Cobicistat and Darunavir, to a Fixed-Dose Combination of Bictegravir/Tenofovir alafenamide/Emtricitabine in Virologically Suppressed HIV-1 Subjects who are known to have a I84 V/I Mutation

Study Overview

• Status: Terminated
• Conditions: HIV-1-infection
• Intervention / Treatment: Drug: Biktarvy Tab

Detailed Description

An Open-Label Study to Evaluate Switching from a Regimen of Elvitegravir/Tenofovir alafenamide/Emtricitabine/Cobicistat and Darunavir, to a Fixed-Dose Combination of Bictegravir/Tenofovir alafenamide/Emtricitabine in Virologically Suppressed HIV-1 Subjects who are known to have a I84 V/I Mutation

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63139
      • Southampton Healthcare, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The ability to understand and sign a written informed consent which must be obtained prior to initiation of study procedures.
• Age equal to or greater than 18 years.
• Currently receiving an ARV regimen of EVG/F/TAF +DRV greater than six month.
• Documented plasma HIV - 1 RNA less than 50 copies/ml during the treatment with Elvitegravir/F/TAF for a minimum of 12 months prior to screening, on two separate determinations, with one determination within 3 months prior to screening.
• Have a documented 184 V/I resistant mutation.
• HIV-1 RNA levels < 50 copies per ml at screening.
• Estimated GFR >than or equal to 30 mls/min.
• AST and ALT equal to or less than 5 times upper limit of normal.
• Total bilirubin less than or equal to 1.5 mg/dl or normal direct bilirubin.
• Adequate hematologic function (absolute neutrophil count equal to or greater than 750/mm to the third, platelets equal to or greater than 50,000/mm to the third, Hemoglobin equal to or greater than 8.5 g/dl).
• Persons of child bearing potential must have negative serum pregnancy test at screening.
• Male participants and persons of child bearing potential who engage in heterosexual intercourse must agree to use our protocol specified methods of contraception.
• Female participants must agree to refrain from egg donation from first dose of FDC of B/F/TAF and throughout the study.
• Male participants must agree to refrain from sperm donation from first dose until at least 30 days after last dose of drug.
• Life expectancy equal to or greater than one year.

Exclusion Criteria:

• No desire to switch from current antiretroviral treatment.
• Any previous use of B/F/TAF.
• Any opportunistic illness indicative of stage 3 HIV diagnosed within 30 days prior to screening.
• Malignancy within 5 years of screening other than cutaneous Kaposi's sarcoma, completed resected non melanoma skin cancer, basal cell carcinoma, or noninvasive cutaneous squamous carcinoma, or completed resected carcinoma in situ of the cervix or anus. A prior malignancy treated with curative therapy and for which there has been no evidence of disease for at least 5 years prior to screening.
• Known hypersensitivity to FDC of B/F/TAF tablets their metabolites or formulation.
• No active treatment of Hepatitis C during the 48 weeks of the study.
• Females who are pregnant confirmed by serum pregnancy test.
• Females who are breast feeding.
• Suspected Biktarvy resistance mutations, except 184 V/I.
• Patients who need to take Dofetilide, Rifampin, Rifapentine, Rifabutin, phenobarbital, phenytoin, carbamazepine, oxcarbazepine, and antiretrovirals not part of the study and St. John's Wart during.
• Acute Hepatitis in the 30 days prior to screening.
• Active tuberculosis infection.
• Current alcohol or substance use judged by the investigator to potentially interfere with subject study compliance.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Open label; Open label Biktarvy to establish suppression of HIV 1 with 184 V/I Resistance Mutation	Drug: Biktarvy Tab; Antiretroviral drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Test the safety and effectiveness of the drug Biktarvy in subjects known to have the 184 V/I resistance mutation.	Pure Virologic Response (PVR) with HIV-1 RNA < 50 copies/mL at week 12.	In 48 week study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Test the safety and effectiveness of the drug Biktarvy in subjects known to have the 184 V/I resistance mutation.	Pure Virologic Response (PVR) with HIV-1 RNA < 50 copies/mL at week 24.	In 48 Week study
Test the safety and effectiveness of the drug Biktarvy in subjects known to have the 184	Pure Virologic Response (PVR) with HIV-1 RNA < 50 copies/mL at week 48	48 Weeks

Collaborators and Investigators

• Sponsor: Southampton Healthcare, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): June 14, 2022
• Study Completion (Actual): July 8, 2022

Study Registration Dates

• First Submitted: July 11, 2019
• First Submitted That Met QC Criteria: July 30, 2019
• First Posted (Actual): July 31, 2019

Study Record Updates

• Last Update Posted (Actual): January 5, 2023
• Last Update Submitted That Met QC Criteria: January 3, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 184 Resistance Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No