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Completed

NCT Number: NCT04538040

Bictegravir/Emtricitabine/Tenofovir Alafenide Plus Doravirine

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.

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Key information

Conditions

HIV-1-infection

Age range

45 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

SFOMG Private Practice

San Francisco, California, 94114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Bictegravir/emtricitabine/tenofovir alafenamide + Doravirine switch

Drug

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 names: Biktarvy + Pifeltro Switch

Primary outcomes

  1. Viral Suppression

    Time frame: 48 Weeks

    Percentage of patients with viral HIV load (VL) <50 and <200 copies/mL at 48 weeks

Secondary outcomes

  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). The range of the scale is 0-10, where 0 means it did not have an affect and 10 means it did have an affect.

  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.

Sponsors and collaborators

Lead sponsor

Quest Clinical Research

Other

Collaborators

  • Gilead Sciences

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 3, 2020
Registry last updated
Mar 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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