Comparison of Two Combinations in Antiretroviral Post-Exposure Prophylaxis for HIV-1: Tenofovir/Emtricitabine (Truvada ®) + Lopinavir/Ritonavir (Kaletra ®) vs Tenofovir/Emtricitabine/Cobicistat/Elvitegravir (Stribild ®). Prospective, Randomized, Open.

Phase 4

Completed

• Conditions: HIV
• Interventions: Drug: Tenofovir + emtricitabine (Truvada),+lopinavir/ritonavir (Kaletra); Drug: elvitegravir/cobicistat/emtricitabine/Tenofovir-Disoproxil

• Registration Number: NCT02198443
• Lead Sponsor: Fundacion Clinic per a la Recerca Biomédica

Brief Summary

The main objective of this study is to compare the tolerability and adherence to a new drug regimen of post-exposure prophylaxis (PEP) for HIV,

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-07
• Study First Submitted: 2014-07-22
• Study First Submitted QC: 2014-07-22
• Study First Posted: 2014-07-23
• Study Start: 2015-06-06
• Primary Completion: 2016-07-15
• Last Update Submitted: 2017-02-20
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Age greater than 18 years
• Have been exposed to HIV, non-occupational and meets the requirements of current recommendations to start with three antiretroviral drugs PEP
• that adequately informed consent in writing to participate in the study and undergo testing and exploration that entails

Exclusion Criteria

• pregnant women, lactating, or those intend become pregnant during the study period.
• subjects who are known or suspected case presents the source resistors to one of the drugs of the pattern of study
• contraindicated treatment with the study drugs, or products under investigation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tenofovir+emtricitabine	Tenofovir + emtricitabine (Truvada),+lopinavir/ritonavir (Kaletra)	-
Elvitegravir/cobicistat/emtricitabine/Tenofovir-Disoproxil	elvitegravir/cobicistat/emtricitabine/Tenofovir-Disoproxil	-

Primary Outcome Measures

Name	Time	Method
Proportion of patients who leave the initial treatment of post-exposure prophylaxis (PEP) for HIV for any reason	Twenty Eigth days	A subject is considered to abandon treatment if within 28 days; * dies; * Do not come to visit week 4; * changed or discontinued study treatment.

Secondary Outcome Measures

Name	Time	Method
time to loss of adherence to TARV	twenty eight days
degree of adhesion during the treatment period	twenty eight days	Measured by pill count and patient adherence questionnaire
Incidence of clinical adverse events and / or laboratory alterations.	twenty-four weeks
Proportion of patients who discontinued treatment due to toxicity or intolerance in each of the treatment arms at 24 weeks follow-up	twenty four weeks
Proportion of patients with seroconversion in both treatment arms at 24 weeks follow-up.	twenty four weeks

Trial Locations

Locations (1)

Hospital clínico y provincial de Barcelona; 🇪🇸 Barcelona, Spain