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.

HIV Clinical Trial

— STRIB-PEP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02198443
• Other study ID #: STRIB-PEP
• Status: Completed
• Phase: Phase 4
• First received: July 22, 2014
• Last updated: February 20, 2017
• Start date: June 6, 2015

Study information

• Verified date: July 2014
• Source: Fundacion Clinic per a la Recerca Biomédica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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,

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. primary completion date: July 15, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV

Intervention

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
• 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.

Locations

Country	Name	City	State
Spain	Hospital clínico y provincial de Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion Clinic per a la Recerca Biomédica

Country where clinical trial is conducted

Spain, 

Outcome

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