NCT00385645

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
255

participants targeted

Target at P75+ for phase_4 hiv-infections

Timeline
Completed

Started May 2006

Typical duration for phase_4 hiv-infections

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 11, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

March 31, 2010

Status Verified

March 1, 2010

Enrollment Period

3.3 years

First QC Date

October 10, 2006

Last Update Submit

March 30, 2010

Conditions

HIV Infections

Keywords

HIV seronegativity

Outcome Measures

Primary Outcomes (1)

  • Proportions of patients completing 28-day antiretroviral treatment (ARVT)

Secondary Outcomes (3)

  • Proportion of HIV-seropositive at 6 months

  • Incidence of adverse effects (clinical and laboratory) during ARVT

  • Adherence to ARVT, time to adherence loss.

Interventions

Combivir+KaletraDRUG
Combivir+ReyatazDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18
  • HIV exposure requiring prophylaxis under current guidelines

You may not qualify if:

  • Pregnancy
  • Suspected drug resistance in source case
  • Contraindications to the study drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital del Mar

Barcelona, Barcelona, 08003, Spain

Location

Hospital de Sant Pau

Barcelona, Barcelona, 08025, Spain

Location

Hospital Vall d'Hebron

Barcelona, Barcelona, 08035, Spain

Location

Hospital Clinic

Barcelona, Barcelona, 08036, Spain

Location

Mutua de Terrassa

Terrassa, Barcelona, 08221, Spain

Location

Hospital Joan XXIII

Tarragona, Tarragona, 43007, Spain

Location

Related Publications (1)

  • Diaz-Brito V, Leon A, Knobel H, Peraire J, Domingo P, Clotet B, Dalmau D, Cruceta A, Arnaiz JA, Gatell JM, Garcia 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.

    PMID: 22293542DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Felipe Garcia, MD

    Hospital Clinic of Barcelona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 10, 2006

First Posted

October 11, 2006

Study Start

May 1, 2006

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

March 31, 2010

Record last verified: 2010-03

Locations

ES(7)