MedTrace Logo

Atazanavir and Lamivudine for Treatment Simplification

NCT00885482 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-03-13

Study results available
· View outcomes & findings →

Summary

Objectives of the study:

1. To verify the safety of the study treatment, defined as the persistent control of the virus' replication at 48 weeks after the simplification to lamivudine + atazanavir with ritonavir.
2. To collect relevant information about the safety and the metabolic impact of this strategy in order to eventually design a non-inferiority randomized controlled trial for the evaluation of the safety and the efficacy of this strategy in the future.

Conditions

  • HIV Infections

Interventions

DRUG

Lamiduvine (Epivir)

Epivir 300 mg

DRUG

Atazanavir (Reyataz)

Reyataz 300 mg

DRUG

Ritonavir (Norvir)

Norvir 100 mg

Sponsors & Collaborators

  • Catholic University of the Sacred Heart

    lead OTHER

Principal Investigators

  • Andrea De Luca, MD · Catholic University of Sacred Heart

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2010-05-31
Completion
2011-05-31

Countries

  • Italy

Study Locations

More Related Trials

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 NCT00885482 on ClinicalTrials.gov