Atazanavir or Lopinavir in HIV Post-exposure Prophylaxis

NCT ID: NCT00385645

Last Updated: 2010-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

255 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2009-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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HIV Infections

Keywords

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HIV seronegativity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Combivir+Kaletra

Intervention Type DRUG

Combivir+Reyataz

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Clinic of Barcelona

OTHER

Sponsor Role lead

Responsible Party

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Hospital Clinic of Barcelona

Principal Investigators

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Felipe Garcia, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic of Barcelona

Locations

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Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, Spain

Site Status

Hospital del Mar

Barcelona, Barcelona, Spain

Site Status

Hospital de Sant Pau

Barcelona, Barcelona, Spain

Site Status

Hospital Vall d'Hebron

Barcelona, Barcelona, Spain

Site Status

Hospital Clinic

Barcelona, Barcelona, Spain

Site Status

Mutua de Terrassa

Terrassa, Barcelona, Spain

Site Status

Hospital Joan XXIII

Tarragona, Tarragona, Spain

Site Status

Countries

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Spain

References

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Diaz-Brito V, Leon A, Knobel H, Peraire J, Domingo P, Clotet B, Dalmau D, Cruceta A, Arnaiz JA, Gatell JM, Garcia F; DATEMPEP study group. Post-exposure prophylaxis for HIV infection: a clinical trial comparing lopinavir/ritonavir versus atazanavir each with zidovudine/lamivudine. Antivir Ther. 2012;17(2):337-46. doi: 10.3851/IMP1955. Epub 2011 Nov 25.

Reference Type DERIVED
PMID: 22293542 (View on PubMed)

Other Identifiers

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DATEM-PEP

Identifier Type: -

Identifier Source: org_study_id