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

• Sponsor: Southampton Healthcare, Inc. (Other)
• Overall Status: Suspended
• CT.gov ID: NCT04040075
• Collaborator: (none)
• Enrollment: 22
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 36.2
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
HIV-1-infection	Drug: Biktarvy Tab	Phase 4

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 22 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: subjects under current treatment for HIV with the I84 I/V Mutation Resistancesubjects under current treatment for HIV with the I84 I/V Mutation Resistance
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Jul 1, 2019
• Actual Primary Completion Date: Jun 14, 2022
• Anticipated Study Completion Date: Jul 8, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Test the safety and effectiveness of the drug Biktarvy in subjects known to have the 184 V/I resistance mutation. [In 48 week study]

   Pure Virologic Response (PVR) with HIV-1 RNA < 50 copies/mL at week 12.

Secondary Outcome Measures

1. Test the safety and effectiveness of the drug Biktarvy in subjects known to have the 184 V/I resistance mutation. [In 48 Week study]

   Pure Virologic Response (PVR) with HIV-1 RNA < 50 copies/mL at week 24.

2. Test the safety and effectiveness of the drug Biktarvy in subjects known to have the 184 [48 Weeks]

   Pure Virologic Response (PVR) with HIV-1 RNA < 50 copies/mL at week 48

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Southampton Healthcare, Inc.	Saint Louis	Missouri	United States	63139

Sponsors and Collaborators

• Southampton Healthcare, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Southampton Healthcare, Inc.
• ClinicalTrials.gov Identifier: NCT04040075
• Other Study ID Numbers: 184 Resistance Study
• First Posted: Jul 31, 2019
• Last Update Posted: Jul 12, 2022
• Last Verified: Jul 1, 2022

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

Study Results

No Results Posted as of Jul 12, 2022