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Pilot Study of a Raltegravir Based NRTI Sparing Regimen

NCT00814879 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-02-04

Study results available
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Summary

This pilot study will provide data on the safety and efficacy of the combination of Raltegravir (RAL) 400mg BID + Atazanavir (ATV) 300 mg BID in Antiretroviral (ARV)-experienced subjects that have a suppressed HIV viral load on a Ritonavir (RTV) boosted Protease Inhibitor (PI) based regimen who are then switched to a regimen of RAL 400mg BID +ATV 300mg BID.

Conditions

  • Acquired Immune Deficiency Syndrome
  • AIDS
  • Human Immunodeficiency Virus
  • HIV Infections

Interventions

DRUG

Raltegravir

400 mg BID

DRUG

Atazanavir

300 mg BID

OTHER

Standard treatment regimen

N(t)RTI(s) based backbone plus ritonavir boosted PI

Sponsors & Collaborators

Principal Investigators

  • Michael J Kozal, MD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2013-05-31
Completion
2013-11-30

Countries

  • United States

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 NCT00814879 on ClinicalTrials.gov