Loading clinical trials...

COMPLETEDPHASE4

Efficacy of Switching to DTG/3TC in Virologically-suppressed Adults Currently on B/F/TAF

Efficacy, Safety and Tolerability of Switching to Dolutegravir/Lamivudine in Virologically-suppressed Adults Living With HIV on Bictegravir/Tenofovir Alafenamide/emtricitabine-the DYAD Study

NCT04585737•Charlotte-Paige Rolle, MD

View on ClinicalTrials.gov

Summary

Phase 4, randomized, open-label study to evaluate the efficacy, safety and tolerability of switching virologically suppressed adults living with HIV on bictegravir/tenofovir alafenamide/emtricitabine to dolutegravir/lamivudine

Detailed Description

Randomized, open-label, active-controlled study of virologically suppressed participants living with HIV Participants who provide written informed consent and meet all the eligibility criteria will be randomized in a 2:1 ratio to one of the following 2 treatment groups: Treatment Group 1 (n=148): FDC of DTG/3TC (50mg/300mg) administered orally, once daily (QD), without regard to food. Treatment Group 2 (n=74): Stay on baseline regimen consisting of FDC of B/F/TAF (50mg/200mg/ 25mg) (taken as prescribed) without regard to food. Randomization will be stratified by gender and race at entry given that this study aims to enroll at least 30% of participants who are female and African American. All participants will be responsible for using their insurance plan to obtain coverage for DTG/3TC and or B/F/TAF, in addition to any labs required by the study. This expectation is clearly outlined in the informed consent. The study team will work with participants to minimize their co-pays for study medications and labs through the use of manufacturer and other external assistance programs. Study duration will be 48 weeks. Number of participants planned: Approximately 222 participants Target Population: HIV-1 infected adult participants who are virologically suppressed (HIV-1 RNA\<50 copies/mL) on FDC of B/F/TAF (50mg/200mg/ 25mg) ≥ 3 months prior to screening

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Aged 18 years or older at the time of signing the informed consent
•TYPE OF SUBJECT AND DIAGNOSIS INCLUDING DISEASE SEVERITY
•2. HIV-1 infected men or women.
•3. Must have a stable form of insurance that is expected to continue without significant changes for at least 48 weeks
•4. Documented evidence of at least two plasma HIV-1 RNA measurements \<50 c/mL at least 3 months apart prior to Day 1 (the screening HIV-1 RNA can count as the second measurement)
•5. Plasma HIV-1 RNA \<50 c/mL at Screening.
•6. Must be on uninterrupted B/F/TAF for at least 3 months prior to screening
•SEX
•7. Male or female A female subject is eligible to participate if she is not pregnant \[as confirmed by a negative serum human chorionic gonadotrophin (hCG) test at screen and a negative urine hCG test at Day
•1/Randomization (a local serum hCG test at Randomization is allowed if it can be done, and results obtained, within 24 hours prior to randomization)\], not lactating, and at least one of the following conditions applies:
+12 more criteria

Exclusion Criteria

•A subject will not be eligible for inclusion in this study if any of the following criteria apply:
•CONCURRENT CONDITIONS/MEDICAL HISTORY
•1. Women who are breastfeeding or plan to become pregnant or breastfeed during the study.
•2. Any evidence of an active Centers for Disease Control and Prevention (CDC) Stage 3 disease \[15\], EXCEPT cutaneous Kaposi's sarcoma not requiring systemic therapy. Historical or current CD4 cell counts less than 200 cells/mm3 are NOT exclusionary.
•3. Subjects with severe hepatic impairment (Class C) as determined by Child-Pugh classification \[16\].
•4. Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
•5. Evidence of Hepatitis B virus (HBV) infection based on the results of testing at Screening for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (antiHBc), Hepatitis B surface antigen antibody (anti-HBs) and HBV DNA as follows:
•* Subjects positive for HBsAg are excluded.
•* Subjects negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded.
•Note: Subjects positive for anti-HBc (negative HBsAg status) and positive for antiHBs (past and/or current evidence) are immune to HBV and are not excluded. AntiHBc must be either total anti-HBc or anti-HBc immunoglobulin G (IgG), and NOT anti-HBc IgM.
+23 more criteria

Locations (1)

Orlando Immunology Center

Orlando, Florida, United States

Key Dates

Start Date

October 5, 2020

Primary Completion Date

August 3, 2023

Completion Date

August 10, 2023

Last Updated

October 17, 2024

Enrollment

222

ACTUAL participants

Conditions

HIV I Infection

Interventions

Dolutegravir / Lamivudine Pill

DRUG

Bictegravir / Emtricitabine / Tenofovir Alafenamide Pill

DRUG

Evaluating the Safety and Immunogenicity of MTBVAC

NCT05947890

HIV I InfectionTuberculosis

View study

RECRUITINGNA

Impact of Pain From Injectables Antiretroviral Treatments in HIV-1 Patients Based on the Injection Site (Ventrogluteal or Dorsogluteal) and the Use or Non-use of Virtual Reality Headset

NCT06834113

HIV I InfectionInjection Pain

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 17, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Efficacy of Switching to DTG/3TC in Virologically-suppressed Adults Currently on B/F/TAF

Inclusion Criteria

Exclusion Criteria

Evaluating the Safety and Immunogenicity of MTBVAC

Impact of Pain From Injectables Antiretroviral Treatments in HIV-1 Patients Based on the Injection Site (Ventrogluteal or Dorsogluteal) and the Use or Non-use of Virtual Reality Headset

Tnf Inhibitors to Reduce Mortality in HIV-1 Infected PAtients With Tuberculosis meNIngitis

A Study Evaluating the Pharmacokinetics, Efficacy, Safety and Tolerability of CABENUVA

Early Empiric Anti-Mycobacterium Tuberculosis Therapy for Sepsis in Sub-Saharan Africa

VIR-1111: A Prototype Human CMV-based Vaccine for Human Immunodeficiency Virus (HIV) in Healthy Volunteers