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A Simplification Study of Unboosted Reyataz With Epzicom (ASSURE)

NCT01102972 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 297

Last updated 2013-11-19

Study results available
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Summary

This study is designed to compare the efficacy and safety of simplifying therapy from a regimen of atazanavir (ATV) + ritonavir (RTV) + tenofovir/emtricitabine (TDF/FTC) to a regimen of ATV + abacavir sulfate/lamivudine (ABC/3TC) without RTV in virologically suppressed, HIV-1 infected, HLA-B\*5701 negative subjects for 48 weeks.

Conditions

  • Infection, Human Immunodeficiency Virus

Interventions

DRUG

Reyataz + Norvir + Truvada

atazanavir 300mg + ritonavir 100mg + tenofovir 300mg/emtricitabine 200mg

DRUG

Reyataz + Epzicom

atazanavir 400mg + abacavir 600mg/lamivudine 300mg

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · ViiV Healthcare

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2012-06-30
Completion
2012-12-31

Countries

  • United States
  • Puerto Rico

Study Locations

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Entities

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 NCT01102972 on ClinicalTrials.gov