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.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-06

Brief Summary

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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,

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Detailed Description

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Conditions

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HIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Tenofovir+emtricitabine

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

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

Elvitegravir/cobicistat/emtricitabine/Tenofovir-Disoproxil

Group Type EXPERIMENTAL

elvitegravir/cobicistat/emtricitabine/Tenofovir-Disoproxil

Intervention Type DRUG

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.

Interventions

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

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

Intervention Type DRUG

elvitegravir/cobicistat/emtricitabine/Tenofovir-Disoproxil

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.

Intervention Type DRUG

Other Intervention Names

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(Stribild)

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No