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OpenTrials
Completed

NCT Number: NCT02198443

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.

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,

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Key information

Conditions

HIV

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital clínico y provincial de Barcelona

Barcelona, 08036, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tenofovir + emtricitabine (Truvada),+lopinavir/ritonavir (Kaletra)

Drug

(TRUVADA) film-coated 200/245 mg tablet / day tablets (Kaletra) film-coated 200/50 mg tablets twice / day tablets

elvitegravir/cobicistat/emtricitabine/Tenofovir-Disoproxil

Drug

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)

Primary outcomes

  1. 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.

Secondary outcomes

  1. Incidence of clinical adverse events and / or laboratory alterations.

    Time frame: twenty-four weeks

  2. 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

  3. degree of adhesion during the treatment period

    Time frame: twenty eight days

    Measured by pill count and patient adherence questionnaire

  4. time to loss of adherence to TARV

    Time frame: twenty eight days

  5. Proportion of patients with seroconversion in both treatment arms at 24 weeks follow-up.

    Time frame: twenty four weeks

Sponsors and collaborators

Lead sponsor

Fundacion Clinic per a la Recerca Biomédica

Other

Registry information

Official study title

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

Acronym: STRIB-PEP

Important dates

Study start
2015
Primary completion
2016
First posted
Jul 23, 2014
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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