COMPARISON OF TWO ANTIRETROVIRAL ALTERNATIVE COMBINATIONS IN HIV-1 POST-EXPOSURE PROPHYLAXIS: TENOFOVIR+EMTRICITABINE (TRUVADA®) + LOPINAVIR/RITONAVIR (KALETRA®) VS TENOFOVIR+EMTRICITABINA+ COBICISTAT + ELVITEGRAVIR (STRIBILD®). A PROSPECTIVE RANDOMIZED OPEN-LABEL STUDY.

Phase 1

• Conditions: Prophilaxis VIH infecction post accidental exposition (PPE); MedDRA version: 17.0Level: LLTClassification code 10020160Term: HIV diseaseSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2014-001193-34-ES
• Lead Sponsor: Fundació Clínic per a la recerca biomèdica

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-21
• Last Update Posted: 31 October 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. equal to or more than 18 years old.
2 have suffered exposure to HIV, not occupational , and which meets the requirements of the current recommendations to initiate PEP with three antiretroviral drugs.
3 that, properly informed, you grant your consent in writing to participate in the study and submit to the tests and scans that entails.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 180
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1 pregnant women, nursing mothers, or those who intend to become pregnant during the study period.
2. subjects that is known or suspected that the source case presented resistance to any of the guidelines of the study drugs.
3. treatment with drugs that are contraindicated with the study, or products under investigation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Compare the rate of dropouts from a new pattern of prophylaxis (PEP) post-exposure HIV with a guideline classic 28 days of treatment.;Secondary Objective: • Compare the tolerability of a new pattern of prophylaxis (PEP) post-exposure HIV with a classic pattern at 24 weeks of follow-up.<br>• Compare the adherence to the treatment of a new pattern of prophylaxis post-exposure (PEP) HIV with a classic pattern during the 28 days of treatment.<br>• Compare the rate of seroconversion of a new pattern of prophylaxis (PEP) post-exposure HIV with a classic pattern at 24 weeks of follow-up;Primary end point(s): Primary endpoint<br>Proportion of patients who leave the initial treatment of prophylaxis post-exposure (PEP) to HIV for any reason within 28 days of treatment.<br><br>A subject is considered that he leaves treatment before 28 days if:<br>1. die<br>2. do not go to visit from week 4<br>3 change or stop treatment in study;Timepoint(s) of evaluation of this end point: N/A

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • Incidence of adverse clinical events I laboratory abnormalities.<br>• Proportion of patients who discontinued treatment toxicity or intolerance in each of the branches of the 24 weeks of follow-up treatment.<br>• Degree of adherence (measured by counting tablets and adherence of the patient questionnaire) during the treatment period.<br>• Time to loss of adherence to art.<br>• Proportion of patients with seroconversion in both branches of treatment at 24 weeks of follow-up.;Timepoint(s) of evaluation of this end point: N/A