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ADVANCE Study of DTG + TAF + FTC vs DTG + TDF + FTC and EFV + TDF+FTC in First-line Antiretroviral Therapy

NCT03122262 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1110

Last updated 2023-02-08

No results posted yet for this study

Summary

This is a non-inferiority (10% non-inferiority margin), study to assess the efficacy and safety of dolutegravir, DTG (50 mg once daily \[QD\]) administered in combination with tenofovir alafenamide fumarate, TAF (25 mg QD) and emtricitabine, FTC (200 mg QD) compared to DTG (50 mg QD) administered in combination with tenofovir disoproxil fumarate, TDF (300 mg QD) and FTC (200 mg QD) and compared to efavirenz, EFV (600 mg QD) administered in combination with TDF (300 mg QD) and FTC (200 mg QD) through 96 weeks in patients with HIV-1 starting first-line ART.

Conditions

  • HIV-1 Infection

Interventions

DRUG

Dolutegravir

DTG 50mg Oral Tablet once daily

DRUG

Tenofovir Alafenamide

TAF/FTC 25/200mg Oral Tablet once daily

DRUG

Truvada

DRUG

Atripla

Sponsors & Collaborators

  • Professor Francois Venter

    lead OTHER

Principal Investigators

  • Willem Daniel Francois Venter, FCP (SA) · Wits Reproductive Health & HIV Institute, University of the Witswatersrand

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-16
Primary Completion
2022-04-30
Completion
2022-07-29

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Drugs

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 NCT03122262 on ClinicalTrials.gov