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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 García, MD, Principal Investigator, Affiliation: Hospital clínic y provincial de Barcelona

Overall contact:
Anna cruceta, MD, Phone: 932275400, Ext: 4380, Email: acruceta@clínic.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@clínic.ub.es

Hospital clínico y provincial de Barcelona, Barcelona 08036, Spain; Not yet recruiting
Anna Cruceta, MD, Phone: 0034932275400, Ext: 4380, Email: acruceta@clínic.ub.es
Lorna Leal, MD, Sub-Investigator
Agathe Leon, MD, Sub-Investigator
Additional Information

Starting date: October 2014
Last updated: July 22, 2014

Page last updated: August 23, 2015

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