Phase 4
Completed N=43
Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in HIV-1 Infected Patients With Active Illicit Substance usE
Source: ClinicalTrials.gov NCT03998176 ↗Enrolled (actual)
43
Serious AEs
34.9%
Results posted
Dec 2022
Primary outcomePrimary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm — 32 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This study will evaluate the efficacy and safety of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in HIV-1 infected patients who actively use illicit substances. The study will also evaluate retention in care and adherence to B/F/TAF by self-report and pharmacokinetic analysis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm |
21 | — |
| SECONDARY Percentage of Participants With Grade 3 or Greater Adverse Events |
15 | — |
| SECONDARY Percentage of Participants With Grade 3 or Greater Adverse Events |
15 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm |
21 | — |
Eligibility Criteria
Inclusion Criteria
- Documented HIV-1 infection
- Treatment naive or experienced
- Self-reported illicit substance use or confirmed urine drug screen within past 6 months of any of the following: cocaine, heroin, methamphetamine, MDMA, phencyclidine, ketamine, gamma hydroxybutyrate, cathiniones, or inappropriate prescription opiate, benzodiazepine or stimulant use (excluding nicotine, alcohol, marijuana for criteria)
- HIV RNA >1000 copies/mL
- Creatinine clearance > 30 mL/min (Cockroft-Gault)
- ALT and AST < 5 times the upper limit of normal
- Willing and able to provide written informed consent
Exclusion Criteria
- History of integrase or tenofovir related HIV resistance mutations
- Pregnancy
- Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to study entry
Data sourced from ClinicalTrials.gov (NCT03998176). 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. Informational only — not medical advice.