Clinical Trials

MainTitle

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
Sponsor
Fundacion Clinic per a la Recerca Biomédica


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: February 20, 2017
Last Verified: July 2014
History of Changes
Purpose

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
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.

Further study details as provided by Anna Cruceta, 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
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)
Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
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

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

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

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  
Study First Received: July 22, 2014  
Last Updated: February 20, 2017  

Additional relevant MeSH terms:
Ritonavir
Lopinavir
Cobicistat
Tenofovir
Emtricitabine
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

ClinicalTrials.gov processed this data on November 20, 2017
This information is provided by ClinicalTrials.gov.