Atazanavir or Lopinavir in HIV Post-exposure Prophylaxis - Full Text View

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Lopinavir Atazanavir Atazanavir sulfate

U.S. FDA Resources

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


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


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
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Hospital Clinic of Barcelona:


HIV seronegativity

Additional relevant MeSH terms:


HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Lopinavir Atazanavir Sulfate Lamivudine, zidovudine drug combination Zidovudine Lamivudine	HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Antimetabolites

ClinicalTrials.gov processed this record on September 23, 2016