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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)

This study has been completed.
Information provided by (Responsible Party):
Anna Cruceta, Fundacion Clinic per a la Recerca Biomédica Identifier:
First received: July 22, 2014
Last updated: February 20, 2017
Last verified: July 2014
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,

Condition Intervention Phase
Drug: Tenofovir + emtricitabine (Truvada),+lopinavir/ritonavir (Kaletra)
Drug: elvitegravir/cobicistat/emtricitabine/Tenofovir-Disoproxil
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Prevention
Official Title: Prophylaxis for HIV-1: Tenofovir/Emtricitabine (Truvada ®) + Lopinavir/Ritonavir (Kaletra ®) vs Tenofovir/Emtricitabine/Cobicistat/Elvitegravir (Stribild ®). Prospective, Randomized, Open.

Resource links provided by NLM:

Further study details as provided by Fundacion Clinic per a la Recerca Biomédica:

Primary Outcome Measures:
  • Proportion of patients who leave the initial treatment of post-exposure prophylaxis (PEP) for HIV for any reason [ Time Frame: 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:
  • 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 [ Time Frame: twenty eight days ]
    Measured by pill count and patient adherence questionnaire

  • 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 ]

Enrollment: 160
Actual Study Start Date: June 6, 2015
Primary Completion Date: July 15, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tenofovir+emtricitabine Drug: 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
Experimental: Elvitegravir/cobicistat/emtricitabine/Tenofovir-Disoproxil 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.
Other Name: (Stribild)


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT02198443

Hospital clínico y provincial de Barcelona
Barcelona, Spain, 08036
Sponsors and Collaborators
Fundacion Clinic per a la Recerca Biomédica
Principal Investigator: Felipe García, MD Hospital clínic y provincial de Barcelona
  More Information

Responsible Party: Anna Cruceta, project manager, Fundacion Clinic per a la Recerca Biomédica Identifier: NCT02198443     History of Changes
Other Study ID Numbers: STRIB-PEP
Study First Received: July 22, 2014
Last Updated: February 20, 2017

Additional relevant MeSH terms:
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
HIV Protease Inhibitors
Protease Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors processed this record on April 28, 2017