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NCT00385645 Clinical Trial

Atazanavir or Lopinavir in HIV Post-exposure Prophylaxis

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00385645
Other study ID # DATEM-PEP
Secondary ID
Status Completed
Phase Phase 4
First received October 10, 2006
Last updated March 30, 2010
Start date May 2006
Est. completion date August 2009

Study information
Verified date March 2010
Source Hospital Clinic of Barcelona
Contact n/a
Is FDA regulated No
Health authority Spain: Spanish Agency of Medicines
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 255
Est. completion date August 2009
Est. primary completion date August 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Combivir+Kaletra

• Combivir+Reyataz

Locations
Country Name City State
Spain Hospital Universitari Germans Trias i Pujol Badalona Barcelona
Spain Hospital Clinic Barcelona
Spain Hospital de Sant Pau Barcelona
Spain Hospital del Mar Barcelona
Spain Hospital Vall d'Hebron Barcelona
Spain Hospital Joan XXIII Tarragona
Spain Mutua de Terrassa Terrassa Barcelona

Sponsors (1)
Lead Sponsor Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportions of patients completing 28-day antiretroviral treatment (ARVT)
Secondary Proportion of HIV-seropositive at 6 months
Secondary Incidence of adverse effects (clinical and laboratory) during ARVT
Secondary Adherence to ARVT, time to adherence loss.
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