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B/F/TAF vs Atripla Double-Blind Switch Study in HIV-1 Infected Adults

NCT03532425 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2022-12-14

Study results available
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Summary

Atripla (ATP: FTC/TDF/EFV) was the first single pill treatment for HIV and was the most prescribed first-line treatment from approximately 2008 to 2013 for people infected with HIV. However, ATP has not been recommended as a "preferred" treatment for HIV since 2015, due to there now being single pill treatments that work better. There are a lot of people who are still taking ATP and it is working for them. However, it has the potential to cause serious side effects (chronic kidney disease and fractures and serious neurological effects). These side effects are caused by components in ATP (namely the TDF and EFV parts). Also, the efavirenz (EFV) component is not compatible for treatment of Hepatitis C (HCV) - which is often also seen in people who have HIV. For these reasons, there is a need to find a better alternative treatment for these people currently being treated with ATP.

Conditions

Interventions

DRUG

B/F/TAF

B/F/TAF (Bictegravir 50mg/ Emtricitabine 200mg/ Tenofovir Alafenamide 25mg) Tablet taken orally once daily

DRUG

Atripla

Atripla (Efavirenz 600mg/ emtricitabine 200 mg/ tenofovir disoproxil 245 mg) Tablet taken orally once daily

DRUG

B/F/TAF Placebo

Tablet taken orally once daily

DRUG

Atripla Placebo

Tablet taken orally once daily

Sponsors & Collaborators

  • Gilead Sciences

    collaborator INDUSTRY

  • University of British Columbia

    collaborator OTHER

  • University of Alberta

    lead OTHER

Principal Investigators

  • Stephen D Shafran, MD · University of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-29
Primary Completion
2020-08-03
Completion
2020-09-03
FDA Drug
Yes

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03532425 on ClinicalTrials.gov