Phase 4
N=20
Bictegravir/Emtricitabine/Tenofovir Alafenide Plus Doravirine
HIV-1-infection
Bottom Line
View on ClinicalTrials.gov: NCT04538040 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Viral Suppression — 100 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Bictegravir/emtricitabine/tenofovir alafenamide + Doravirine switch (Drug)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- Male
- Sponsor
- Quest Clinical Research
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Viral Suppression |
100 | — |
| SECONDARY Tolerability of Study Drug |
16 | — |
| SECONDARY Change in Body Mass Index |
-0.2 | — |
| SECONDARY Work Productivity and Activity |
0; 0; 0 | — |
| SECONDARY PK Assessment |
8.55; 1.2 | — |
| SECONDARY Adverse Events Assessment |
14; 1; 1 | — |
| SECONDARY Wellbeing Improvement |
7 | — |
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.
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT04538040). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.