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 Overview
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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,

Official Title
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Prophylaxis for HIV-1: Tenofovir/Emtricitabine (Truvada ®) + Lopinavir/Ritonavir (Kaletra ®) vs Tenofovir/Emtricitabine/Cobicistat/Elvitegravir (Stribild ®). Prospective, Randomized, Open.

Conditions
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HIV

Intervention / Treatment
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* Drug: Tenofovir + emtricitabine (Truvada),+lopinavir/ritonavir (Kaletra)
* Drug: elvitegravir/cobicistat/emtricitabine/Tenofovir-Disoproxil


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tenofovir+emtricitabine<br> | Drug: Tenofovir + emtricitabine (Truvada),+lopinavir/ritonavir (Kaletra)<br>* (TRUVADA) film-coated 200/245 mg tablet / day tablets (Kaletra) film-coated 200/50 mg tablets twice / day tablets<br>|
| Experimental: Elvitegravir/cobicistat/emtricitabine/Tenofovir-Disoproxil<br> | Drug: elvitegravir/cobicistat/emtricitabine/Tenofovir-Disoproxil<br>* 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.<br>* Other names: (Stribild);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Twenty Eigth days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| degree of adhesion during the treatment period | Measured by pill count and patient adherence questionnaire | twenty eight days | 
| time to loss of adherence to TARV |  | twenty eight days | 
| Proportion of patients with seroconversion in both treatment arms at 24 weeks follow-up. |  | twenty four weeks |