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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)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2014 by Fundacion Clinic per a la Recerca Biomédica.
Recruitment status was:  Not yet recruiting
Information provided by (Responsible Party):
Anna Cruceta, Fundacion Clinic per a la Recerca Biomédica Identifier:
First received: July 22, 2014
Last updated: NA
Last verified: July 2014
History: No changes posted
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: Open Label
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 ]

Estimated Enrollment: 160
Study Start Date: October 2014
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: March 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: July 22, 2014

Additional relevant MeSH terms:
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors processed this record on February 20, 2017