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BMS-Reyataz Study in Treatment in Naive Subjects to Compare the Efficacy and Safety Between Boosted Reyataz and Kaletra When in Combination With Fixed Dose Truvada

NCT00272779 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1057

Last updated 2011-05-09

Study results available
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Summary

The purpose of this study is to evaluate the safety, tolerability and antiviral effects of atazanavir (ATV) plus ritonavir (RTV) versus a combination drug of lopinavir (LPV) plus RTV. A combination drug containing tenofovir (TDF) and emtricitabine (FTC) will also be taken by participants in both arms.

Conditions

  • HIV Infections

Interventions

DRUG

ATV

300mg Oral capsules for 96 weeks

DRUG

RTV

100mg Oral Capsules for 96 weeks

DRUG

Tenofovi-Emtricitabine (TDF/FTC) tablet

One tablet with 300 mg - 200 mg once a day for 96 weeks.

DRUG

LPV

400 mg (3 133mg capsules) BID for 96 weeks

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2007-06-30
Completion
2008-10-31

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • Chile
  • Colombia
  • Costa Rica
  • Dominican Republic
  • France
  • Germany
  • Guatemala
  • Hong Kong
  • Indonesia
  • Italy
  • Mexico
  • Netherlands
  • Panama
  • Peru
  • Portugal
  • Puerto Rico
  • Singapore
  • South Africa
  • Spain
  • Taiwan
  • Thailand
  • 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 NCT00272779 on ClinicalTrials.gov