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Bictegravir/Emtricitabine/Tenofovir Alafenide Plus Doravirine

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ClinicalTrials.gov Identifier: NCT04538040
Recruitment Status : Active, not recruiting
First Posted : September 3, 2020
Last Update Posted : September 11, 2020
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Quest Clinical Research

Study Description
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Brief Summary:

The current study proposal is an open label observational trial for maintenance of virologic suppression, and is designed as a non- inferiority switch trial. The study will involve approximately 30 patients, which includes a PK arm of approximately 10 patients. The study will also include secondary outcomes of quality of life (QOL) and weight changes

Hypothesis:

Patients with prior NUC or NNRTI resistance (but not to rilpivirine or doravirine) will maintain their virologic suppression after a drug regimen switch from rilpivirine/emtricitabine/tenofovir alafenamide in combination with dolutegravir, to bictegravir/emtricitabine/tenofovir alafenamide in combination with doravirine. The switch therapy will avoid food interactions, and will be well tolerated by subjects.


Condition or disease Intervention/treatment Phase
HIV-1-infection Drug: Bictegravir/emtricitabine/tenofovir alafenamide + Doravirine switch Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Study Evaluating the Safety and Efficacy of Switching From Rilpivirine/Emtricitabine/Tenofovir Alafenamide in Combination With Dolutegravir, to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Combination With Doravirine, in Male HIV+ Subjects > 45 Years With Multi-drug Resistant Virus and Virologic Suppression (Documented With at Least One Viral Load Result < 50 Copies Per mL) During the Last 6 Months on Current Therapy
Actual Study Start Date : December 19, 2019
Estimated Primary Completion Date : April 21, 2021
Estimated Study Completion Date : April 21, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
Experimental: Biktarvy + Doravirine Switch
bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg tablets + doravirine 100mg tablets taken orally once per day
 Drug: Bictegravir/emtricitabine/tenofovir alafenamide + Doravirine switch
Safety and efficacy of switching from rilpivirine/emtricitabine/tenofovir alafenamide in combination with dolutegravir, to bictegravir/emtricitabine/tenofovir alafenamide in combination with doravirine in male, 45+ year old subjects. The study will also include secondary outcomes of quality of life (QOL) and weight changes.
Other Name: Biktarvy + Pifeltro Switch


Outcome Measures
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Primary Outcome Measures :
  1. Viral Suppression [ Time Frame: 48 Weeks ]
    Percentage of patients with viral HIV load (VL) <50 and <200 copies/mL at 48 weeks


Secondary Outcome Measures :
  1. Tolerability of study drug [ Time Frame: Week 48 ]
    Tolerability of study drugs will be assessed by summarizing the number of AE/SAEs occurring during the study

  2. Change in Body Mass Index [ Time Frame: Week 48 ]
    Assess changes in BMI due to treatment switch

  3. Work Productivity and Activity [ Time Frame: Week 48 ]
    Improvement in work productivity and activity as measured by Work Productivity and Activity Impairment Questionnaire (WPAI)

  4. PK Assessment [ Time Frame: Week 4 (+/- 14 days) with time points at predose (-0.5 hr), 0.5, 1, 2, 4, 6, 8, 12, and 24 hours ]
    Subject plasma concentration-time data of bictegravir and doravirine will be analyzed using non-compartmental model (WinNonlin®)

  5. Adverse Events Assessment [ Time Frame: Day 28, Weeks 12, 24, 36, & 48 ]
    Assess AE's of any grade and relationship to the drug combination occurring in at least 5% of participants or more.

  6. Wellbeing Improvement [ Time Frame: Week 48 ]
    Improvement in well-being and sleep inventory as measured by The Pittsburgh Sleep Quality Index (PSQI). Minimum score is 0 and maximum score is 21. A higher score indicates worse quality sleep.


Eligibility Criteria
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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV positive Males, age 45 or older
  • Any genotypic or phenotypic resistance except k65R, 69 insertion, integrase resistance, or resistance to rilpivarine or doravirine.
  • Receiving combination antiretroviral regimen of rilpivirine/emtricitabine/tenofovir alafenamide in combination with dolutegravir > 12 months and with viral load <50 copies/ mL on at least one occasion within the six months prior to switch.
  • Suppressed viral load as defined by one plasma HIV RNA level < 50 copies/mL within previous 6 months.
  • Capable of providing informed consent

Exclusion Criteria:

  • Any current or prior integrase inhibitor resistance
  • Nucleoside reverse transcriptase (NRTI) mutation 69 insertion or k65R mutation
  • Documented second generation non-nucleoside reverse transcriptase inhibitor (NNRTI) resistance (rilpivirine or doravirine)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04538040


Locations
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United States, California
SFOMG Private Practice
San Francisco, California, United States, 94114
Sponsors and Collaborators
Quest Clinical Research
Gilead Sciences
More Information
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Responsible Party: Quest Clinical Research
ClinicalTrials.gov Identifier: NCT04538040    
Other Study ID Numbers: BETD-001
First Posted: September 3, 2020    Key Record Dates
Last Update Posted: September 11, 2020
Last Verified: September 2020

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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
Keywords provided by Quest Clinical Research:
multi-drug resistant
Additional relevant MeSH terms:
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Tenofovir
Emtricitabine
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
 Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents