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Atazanavir or Lopinavir in HIV Post-exposure Prophylaxis

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Combivir+Kaletra
Combivir+Reyataz
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring HIV seronegativity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Universitari Germans Trias i Pujol
  • Mutua de Terrassa
  • Hospital del Mar
  • Hospital de Sant Pau
  • Hospital Vall d'Hebron
  • Hospital Clinic
  • Hospital Joan XXIII

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 10, 2006
Last Updated
March 30, 2010
Sponsor
Hospital Clinic of Barcelona
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1. Study Identification

Unique Protocol Identification Number
NCT00385645
Brief Title
Atazanavir or Lopinavir in HIV Post-exposure Prophylaxis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital Clinic of Barcelona

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV seronegativity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
255 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Combivir+Kaletra
Intervention Type
Drug
Intervention Name(s)
Combivir+Reyataz
Primary Outcome Measure Information:
Title
Proportions of patients completing 28-day antiretroviral treatment (ARVT)
Secondary Outcome Measure Information:
Title
Proportion of HIV-seropositive at 6 months
Title
Incidence of adverse effects (clinical and laboratory) during ARVT
Title
Adherence to ARVT, time to adherence loss.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felipe Garcia, MD
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Mutua de Terrassa
City
Terrassa
State/Province
Barcelona
ZIP/Postal Code
08221
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital de Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Joan XXIII
City
Tarragona
ZIP/Postal Code
43007
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
22293542
Citation
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.
Results Reference
derived

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Atazanavir or Lopinavir in HIV Post-exposure Prophylaxis

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