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 is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by Fundacion Clinic per a la Recerca Biomédica
Sponsor:
Information provided by (Responsible Party):
Anna Cruceta, Fundacion Clinic per a la Recerca Biomédica
ClinicalTrials.gov Identifier:
NCT02198443
First received: July 22, 2014
Last updated: NA
Last verified: July 2014
History: No changes posted
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • degree of adhesion during the treatment period [ Time Frame: twenty eight days ] [ Designated as safety issue: No ]
    Measured by pill count and patient adherence questionnaire

  • time to loss of adherence to TARV [ Time Frame: twenty eight days ] [ Designated as safety issue: No ]
  • Proportion of patients with seroconversion in both treatment arms at 24 weeks follow-up. [ Time Frame: twenty four weeks ] [ Designated as safety issue: No ]

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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: NCT02198443

Contacts
Contact: Anna cruceta, MD 932275400 ext 4380 acruceta@clínic.ub.es

Locations
Spain
Hospital clínico y provincial de Barcelona Not yet recruiting
Barcelona, Spain, 08036
Contact: Anna Cruceta, MD    0034932275400 ext 4380    acruceta@clínic.ub.es   
Sub-Investigator: Lorna Leal, MD         
Sub-Investigator: Agathe Leon, MD         
Sponsors and Collaborators
Fundacion Clinic per a la Recerca Biomédica
Investigators
Principal Investigator: Felipe García, MD Hospital clínic y provincial de Barcelona
  More Information

No publications provided

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
Study First Received: July 22, 2014
Last Updated: July 22, 2014
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Additional relevant MeSH terms:
Ritonavir
Lopinavir
Tenofovir
Tenofovir disoproxil
Emtricitabine
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on October 02, 2014