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
Prophylaxis for HIV-1: Tenofovir/Emtricitabine (Truvada ®) + Lopinavir/Ritonavir (Kaletra ®) vs Tenofovir/Emtricitabine/Cobicistat/Elvitegravir (Stribild ®). Prospective, Randomized, Open.
1 other identifier
interventional
160
1 country
1
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,
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 hiv
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2014
CompletedFirst Posted
Study publicly available on registry
July 23, 2014
CompletedStudy Start
First participant enrolled
June 6, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2016
CompletedFebruary 23, 2017
July 1, 2014
1.1 years
July 22, 2014
February 20, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of patients who leave the initial treatment of post-exposure prophylaxis (PEP) for HIV for any reason
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 Outcomes (5)
Incidence of clinical adverse events and / or laboratory alterations.
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
twenty four weeks
degree of adhesion during the treatment period
twenty eight days
time to loss of adherence to TARV
twenty eight days
Proportion of patients with seroconversion in both treatment arms at 24 weeks follow-up.
twenty four weeks
Study Arms (2)
Tenofovir+emtricitabine
ACTIVE COMPARATORElvitegravir/cobicistat/emtricitabine/Tenofovir-Disoproxil
EXPERIMENTALInterventions
(TRUVADA) film-coated 200/245 mg tablet / day tablets (Kaletra) film-coated 200/50 mg tablets twice / day tablets
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital clínico y provincial de Barcelona
Barcelona, Barcelona, 08036, Spain
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Felipe García, MD
Hospital clínic y provincial de Barcelona
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- project manager
Study Record Dates
First Submitted
July 22, 2014
First Posted
July 23, 2014
Study Start
June 6, 2015
Primary Completion
July 15, 2016
Last Updated
February 23, 2017
Record last verified: 2014-07