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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)

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ClinicalTrials.gov Identifier: NCT02198443
Recruitment Status : Completed
First Posted : July 23, 2014
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Anna Cruceta, Fundacion Clinic per a la Recerca Biomédica

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
HIV Drug: Tenofovir + emtricitabine (Truvada),+lopinavir/ritonavir (Kaletra) Drug: elvitegravir/cobicistat/emtricitabine/Tenofovir-Disoproxil Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Actual Study Start Date : June 6, 2015
Actual Primary Completion Date : July 15, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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)


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. Incidence of clinical adverse events and / or laboratory alterations. [ Time Frame: twenty-four weeks ]
  2. 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 ]
  3. degree of adhesion during the treatment period [ Time Frame: twenty eight days ]
    Measured by pill count and patient adherence questionnaire

  4. time to loss of adherence to TARV [ Time Frame: twenty eight days ]
  5. Proportion of patients with seroconversion in both treatment arms at 24 weeks follow-up. [ Time Frame: twenty four weeks ]

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

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02198443


Locations
Spain
Hospital clínico y provincial de Barcelona
Barcelona, Spain, 08036
Sponsors and Collaborators
Fundacion Clinic per a la Recerca Biomédica
Investigators
Principal Investigator: Felipe García, MD Hospital clínic y provincial de Barcelona
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Anna Cruceta, project manager, Fundacion Clinic per a la Recerca Biomédica
ClinicalTrials.gov Identifier: NCT02198443     History of Changes
Other Study ID Numbers: STRIB-PEP
First Posted: July 23, 2014    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: July 2014

Additional relevant MeSH terms:
Ritonavir
Lopinavir
Cobicistat
Tenofovir
Emtricitabine
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