Atazanavir or Lopinavir in HIV Post-Exposure Prophylaxis

This study is not yet open for participant recruitment.

Verified by Hospital Clinic of Barcelona, October 2006

First Received: October 10, 2006 Last Updated: January 10, 2007 History of Changes

Sponsor:	Hospital Clinic of Barcelona
Information provided by:	Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:	NCT00385645

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 IV

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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: AIDS

Drug Information available for: Combivir Lopinavir BMS 232632 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.

Estimated Enrollment:

240

Eligibility

Ages Eligible for Study:	18 Years and older
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

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

Contacts

Contact: Felipe Garcia, MD	34932275400 ext 2884	fgarcia@clinic.ub.es
Contact: Juan A Arnaiz, MD	34932279838	jaarnaiz@clinic.ub.es

Locations

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

Sponsors and Collaborators

Hospital Clinic of Barcelona

Investigators

Principal Investigator:

Felipe Garcia, MD

Hospital Clinic, Barcelona

More Information

No publications provided

Study ID Numbers:	DATEM-PEP
Study First Received:	October 10, 2006
Last Updated:	January 10, 2007
ClinicalTrials.gov Identifier:	NCT00385645 History of Changes
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Hospital Clinic of Barcelona:

HIV seronegativity

Additional relevant MeSH terms:

Anti-Infective Agents
HIV Protease Inhibitors
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Atazanavir
Infection

Antiviral Agents
Pharmacologic Actions
Immunologic Deficiency Syndromes
Protease Inhibitors
Virus Diseases
Anti-Retroviral Agents
Lopinavir
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on February 08, 2010