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Clinical Trials

MainTitle

Atazanavir or Lopinavir in HIV Post-exposure Prophylaxis

This study has been completed
Sponsor
Hospital Clinic of Barcelona


Information provided by (Responsible Party)
Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier
NCT00385645

First received: October 10, 2006
Last updated: March 30, 2010
Last Verified: March 2010
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
HIV Infections

Drug : Combivir+Kaletra
Drug : Combivir+Reyataz
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Further study details as provided by Hospital Clinic of Barcelona:

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.

Enrollment: 255
Study Start Date: May 2006
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00385645

Locations

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

Sponsors and Collaborators

Hospital Clinic of Barcelona

Investigators

Principal Investigator: Felipe Garcia, MD Hospital Clinic of Barcelona
More Information

More Information


Responsible Party: Felipe Garcia Alcaide, Hospital Clinic of Barcelona  
ClinicalTrials.gov Identifier: NCT00385645   History of Changes  
Other Study ID Numbers: DATEM-PEP  
Study First Received: October 10, 2006  
Last Updated: March 30, 2010  

Keywords provided by Hospital Clinic of Barcelona:

HIV seronegativity

Additional relevant MeSH terms:
HIV Infections
Lopinavir
Atazanavir Sulfate
Lamivudine, zidovudine drug combination
Zidovudine
Lamivudine

ClinicalTrials.gov processed this data on October 18, 2017
This information is provided by ClinicalTrials.gov.