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Atazanavir/Ritonavir, Once Daily + Raltegravir, Twice Daily, Switch Study in HIV-1-Infected Patients

NCT01332227 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2015-02-19

Study results available
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Summary

The purpose of this study is to determine whether HIV-1-infected patients, who are virologically suppressed on a regimen of 2 nucleoside reverse transcriptase inhibitors plus any third agent but are experiencing safety and/or tolerability issues, will maintain virologic suppression after switching to a regimen of heat-stable ritonavir boosted atazanavir, 300/100 mg, once daily plus raltegravir, 400 mg, twice daily.

Conditions

  • HIV, Combination Therapy

Interventions

DRUG

Atazanavir

Capsules, Oral, 300mg, Once daily, 48 weeks

DRUG

Ritonavir (heat-stable)

Tablets, Oral, 100 mg, Once daily, 48 weeks

DRUG

Raltegravir

Tablets, Oral, 400 mg, Twice daily, 48 weeks

DRUG

Tenofovir/Emtricitabine

Tablets, Oral, 300/200 mg, Once daily, 48 weeks

Sponsors & Collaborators

Principal Investigators

  • Bristol-Mayers Squibb · Bristol-Mayers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2013-09-30
Completion
2014-02-28

Countries

  • United States
  • France
  • Germany
  • Italy
  • Poland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

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 NCT01332227 on ClinicalTrials.gov