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)

February 20, 2017 updated by: Anna Cruceta, Fundacion Clinic per a la Recerca Biomédica

Prophylaxis for HIV-1: Tenofovir/Emtricitabine (Truvada ®) + Lopinavir/Ritonavir (Kaletra ®) vs Tenofovir/Emtricitabine/Cobicistat/Elvitegravir (Stribild ®). Prospective, Randomized, Open.

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,

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clínico y Provincial de Barcelona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • (Stribild)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Twenty Eigth days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of clinical adverse events and / or laboratory alterations.
Time Frame: twenty-four weeks
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
twenty four weeks
degree of adhesion during the treatment period
Time Frame: twenty eight days
Measured by pill count and patient adherence questionnaire
twenty eight days
time to loss of adherence to TARV
Time Frame: twenty eight days
twenty eight days
Proportion of patients with seroconversion in both treatment arms at 24 weeks follow-up.
Time Frame: twenty four weeks
twenty four weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion Clinic per a la Recerca Biomédica

Investigators

  • Principal Investigator: Felipe García, MD, Hospital Clinic y Provincial de Barcelona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 6, 2015

Primary Completion (ACTUAL)

July 15, 2016

Study Registration Dates

First Submitted

July 22, 2014

First Submitted That Met QC Criteria

July 22, 2014

First Posted (ESTIMATE)

July 23, 2014

Study Record Updates

Last Update Posted (ACTUAL)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 20, 2017

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STRIB-PEP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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