Atazanavir or Lopinavir in HIV Post-exposure Prophylaxis

March 30, 2010 updated by: Hospital Clinic of Barcelona

Comparison of 2 Alternative Antiretroviral Combinations in HIV Post-exposure Prophylaxis: AZT-3TC (Combivir®) + Lopinavir-ritonavir (Kaletra®) Versus AZT-3TC (Combivir®)+ Atazanavir (Reyataz®). Multicentre, Prospective, Randomized, Open Study

The study compares the adherence of 240 HIV-negative subjects randomly assigned to 2 different antiretroviral therapies for 28 days after accidental exposure to HIV.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

255

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Barcelona, Spain, 08025
        • Hospital de Sant Pau
      • Barcelona, Spain, 08035
        • Hospital Vall d'Hebron
      • Barcelona, Spain, 08036
        • Hospital Clínic
      • Tarragona, Spain, 43007
        • Hospital Joan XXIII
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Universitari Germans Trias i Pujol
      • Terrassa, Barcelona, Spain, 08221
        • Mutua de Terrassa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age > 18
  • HIV exposure requiring prophylaxis under current guidelines

Exclusion Criteria:

  • Pregnancy
  • Suspected drug resistance in source case
  • Contraindications to the study drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Proportions of patients completing 28-day antiretroviral treatment (ARVT)

Secondary Outcome Measures

Outcome Measure
Proportion of HIV-seropositive at 6 months
Incidence of adverse effects (clinical and laboratory) during ARVT
Adherence to ARVT, time to adherence loss.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinic of Barcelona

Investigators

  • Principal Investigator: Felipe García, MD, Hospital Clinic of Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

October 10, 2006

First Submitted That Met QC Criteria

October 10, 2006

First Posted (Estimate)

October 11, 2006

Study Record Updates

Last Update Posted (Estimate)

March 31, 2010

Last Update Submitted That Met QC Criteria

March 30, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DATEM-PEP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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