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.
Information source: Fundacion Clinic per a la Recerca Biomédica
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV
Intervention: Tenofovir + emtricitabine (Truvada),+lopinavir/ritonavir (Kaletra) (Drug); elvitegravir/cobicistat/emtricitabine/Tenofovir-Disoproxil (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Fundacion Clinic per a la Recerca Biomédica Official(s) and/or principal investigator(s): Felipe GarcÃa, MD, Principal Investigator, Affiliation: Hospital clÃnic y provincial de Barcelona
Overall contact: Anna cruceta, MD, Phone: 932275400, Ext: 4380, Email: acruceta@clÃnic.ub.es
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,
Clinical Details
Official title: Prophylaxis for HIV-1: Tenofovir/Emtricitabine (Truvada ®) + Lopinavir/Ritonavir (Kaletra ®) vs Tenofovir/Emtricitabine/Cobicistat/Elvitegravir (Stribild ®). Prospective, Randomized, Open.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Proportion of patients who leave the initial treatment of post-exposure prophylaxis (PEP) for HIV for any reason
Secondary outcome: Incidence of clinical adverse events and / or laboratory alterations.Proportion of patients who discontinued treatment due to toxicity or intolerance in each of the treatment arms at 24 weeks follow-up degree of adhesion during the treatment period time to loss of adherence to TARV Proportion of patients with seroconversion in both treatment arms at 24 weeks follow-up.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Anna cruceta, MD, Phone: 932275400, Ext: 4380, Email: acruceta@clÃnic.ub.es
Hospital clÃnico y provincial de Barcelona, Barcelona 08036, Spain; Not yet recruiting Anna Cruceta, MD, Phone: 0034932275400, Ext: 4380, Email: acruceta@clÃnic.ub.es Lorna Leal, MD, Sub-Investigator Agathe Leon, MD, Sub-Investigator
Additional Information
Starting date: October 2014
Last updated: July 22, 2014
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