Atazanavir or Lopinavir in HIV Post-exposure Prophylaxis

This study has been completed.
Sponsor:
Information provided by:
Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT00385645
First received: October 10, 2006
Last updated: March 30, 2010
Last verified: March 2010

October 10, 2006
March 30, 2010
May 2006
August 2009   (final data collection date for primary outcome measure)
Proportions of patients completing 28-day antiretroviral treatment (ARVT)
Same as current
Complete list of historical versions of study NCT00385645 on ClinicalTrials.gov Archive Site
  • Proportion of HIV-seropositive at 6 months
  • Incidence of adverse effects (clinical and laboratory) during ARVT
  • Adherence to ARVT, time to adherence loss.
Same as current
Not Provided
Not Provided
 
Atazanavir or Lopinavir in HIV Post-exposure Prophylaxis
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV Infections
  • Drug: Combivir+Kaletra
  • Drug: Combivir+Reyataz
Not Provided
Diaz-Brito V, León A, Knobel H, Peraire J, Domingo P, Clotet B, Dalmau D, Cruceta A, Arnaiz JA, Gatell JM, García 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
255
August 2009
August 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00385645
DATEM-PEP
Not Provided
Felipe Garcia Alcaide, Hospital Clinic of Barcelona
Hospital Clinic of Barcelona
Not Provided
Principal Investigator: Felipe Garcia, MD Hospital Clinic of Barcelona
Hospital Clinic of Barcelona
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP