Atazanavir or Lopinavir in HIV Post-exposure Prophylaxis

Phase 4

Completed

• Conditions: HIV Infections

• Registration Number: NCT00385645
• Lead Sponsor: Hospital Clinic of Barcelona

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-10-10
• Study First Submitted QC: 2006-10-10
• Study First Posted: 2006-10-11
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Status Verified: 2010-03
• Last Update Submitted: 2010-03-30
• Last Update Posted: 2010-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 255

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proportions of patients completing 28-day antiretroviral treatment (ARVT)

Secondary Outcome Measures

Name	Time	Method
Proportion of HIV-seropositive at 6 months
Incidence of adverse effects (clinical and laboratory) during ARVT
Adherence to ARVT, time to adherence loss.

Trial Locations

Locations (7)

Hospital Universitari Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain

Mutua de Terrassa; 🇪🇸 Terrassa, Barcelona, Spain

Hospital Vall d'Hebron; 🇪🇸 Barcelona, Spain

Hospital de Sant Pau; 🇪🇸 Barcelona, Spain

Hospital del Mar; 🇪🇸 Barcelona, Spain

Hospital Clinic; 🇪🇸 Barcelona, Spain

Hospital Joan XXIII; 🇪🇸 Tarragona, Spain