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. (STRIB-PEP)

Fundacion Clinic per a la Recerca Biomédica

Status and phase: Completed; Phase 4

Conditions: HIV

Treatments: Drug: elvitegravir/cobicistat/emtricitabine/Tenofovir-Disoproxil; Drug: Tenofovir + emtricitabine (Truvada),+lopinavir/ritonavir (Kaletra)

Study type: Interventional

Funder types: Other

Identifiers

NCT02198443

STRIB-PEP

Details and patient eligibility

About

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,

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Tenofovir+emtricitabine

Active Comparator group

Treatment:

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

Elvitegravir/cobicistat/emtricitabine/Tenofovir-Disoproxil

Experimental group

Treatment:

Drug: elvitegravir/cobicistat/emtricitabine/Tenofovir-Disoproxil