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 4CompletedNCT02198443

Fundacion Clinic per a la Recerca Biomédica160 enrolled

Overview

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,

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

160

Conditions

HIV

Interventions

Tenofovir + emtricitabine (Truvada),+lopinavir/ritonavir (Kaletra)DRUG

(TRUVADA) film-coated 200/245 mg tablet / day tablets (Kaletra) film-coated 200/50 mg tablets twice / day tablets

elvitegravir/cobicistat/emtricitabine/Tenofovir-DisoproxilDRUG

Film-coated tablets of 150 mg of elvitegravir, cobicistat 150 mg, 200 mg of emtricitabine and 245 mg of tenofovir disoproxil. One tablet once / day.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital clínico y provincial de Barcelona

Barcelona, Barcelona, Spain

Outcomes

Primary Outcomes

Proportion of patients who leave the initial treatment of post-exposure prophylaxis (PEP) for HIV for any reason

A subject is considered to abandon treatment if within 28 days * dies * Do not come to visit week 4 * changed or discontinued study treatment.

Time frame: Twenty Eigth days

Secondary Outcomes

Incidence of clinical adverse events and / or laboratory alterations.

Time frame: 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

Time frame: twenty four weeks

degree of adhesion during the treatment period

Measured by pill count and patient adherence questionnaire

Time frame: twenty eight days

time to loss of adherence to TARV

Time frame: twenty eight days

Proportion of patients with seroconversion in both treatment arms at 24 weeks follow-up.

Time frame: twenty four weeks

Data from ClinicalTrials.gov

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