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Changes in Triglyceride and Other Lipids (Levels of Fats Found in Blood) When Taking Darunavir Compared to Atazanavir in HIV-infected Patients That Have Never Received Treatment

NCT00757783 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2015-12-30

Study results available
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Summary

The purpose of this research study is to compare changes in triglyceride and other lipids (levels of fats found in the blood) from Baseline (Day 1) to Week 12 for darunavir/ritonavir 800/100 mg once daily versus atazanavir/ritonavir 300/100 mg once daily in combination with a fixed-dose background regimen consisting of emtricitabine \[FTC\]/tenofovir \[TDF\] 200/300 mg once daily). This study will also evaluate the safety (adverse events), effectiveness, and tolerability of darunavir/ritonavir and atazanivir/ritonavir over 48 weeks.

Conditions

Interventions

DRUG

ritonavir

100 mg capsule or tablet once daily for 48 weeks

DRUG

ritonavir

100 mg capsule or tablet once daily for 48 weeks

DRUG

darunavir

800 mg tablet once daily for 48 weeks

DRUG

emtricitabine [FTC]/tenofovir [TDF]

200/300 mg tablet once daily for 48 weeks

DRUG

emtricitabine [FTC]/tenofovir [TDF]

200/300 mg once daily for 48 weeks

DRUG

atazanavir

300 mg capsule once daily for 48 weeks

Sponsors & Collaborators

  • Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA

    collaborator INDUSTRY

  • Tibotec, Inc

    lead INDUSTRY

Principal Investigators

  • Tibotec, Inc. Clinical Trial · Tibotec, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2009-08-31
Completion
2012-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00757783 on ClinicalTrials.gov