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Dolutegravir Antiretroviral Strategy to Promote Improvement and Reduce Drug Exposure

NCT02263326 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2019-10-14

Study results available
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Summary

HIV-1 infected subjects with CD4 nadir \> 200 cells/mm3, no history of virologic failure and plasma HIV RNA \<50 copies/mL for at least 48 weeks while on any United States Department of Health and Human Services (DHHS) recommended or alternative three-drug antiretroviral regimen will be randomized to dolutegravir (DTG) plus lamivudine (Arm 1) or continuation of their current regimen (Arm 2) for 48 weeks. The primary endpoint is virologic failure defined as confirmed plasma HIV-1 RNA \> 50 copies/mL before or at Week 24

Conditions

  • HIV Infection

Interventions

DRUG

dolutegravir

50 mg tablet by mouth once daily for 48 weeks

DRUG

lamivudine

300 mg tablet by mouth once daily for 48 weeks

DRUG

Continue current antiretroviral regimen

Continue current DHHS recommended or alternative three-drug antiretroviral regimen

Sponsors & Collaborators

  • ViiV Healthcare

    collaborator INDUSTRY

  • Babafemi Taiwo

    lead OTHER

Principal Investigators

  • Babafemi Taiwo, MBBS · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2017-07-31
Completion
2017-09-30

Countries

  • United States

Study Locations

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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 NCT02263326 on ClinicalTrials.gov