Atazanavir or Lopinavir in HIV Post-exposure Prophylaxis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00385645
Recruitment Status : Completed
First Posted : October 11, 2006
Last Update Posted : March 31, 2010
Information provided by:
Hospital Clinic of Barcelona

October 10, 2006
October 11, 2006
March 31, 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 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
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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
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 Identifier (NCT Number) in Medline.
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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
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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