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)
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ClinicalTrials.gov Identifier: NCT02198443 |
Recruitment Status
:
Completed
First Posted
: July 23, 2014
Last Update Posted
: February 23, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV | Drug: Tenofovir + emtricitabine (Truvada),+lopinavir/ritonavir (Kaletra) Drug: elvitegravir/cobicistat/emtricitabine/Tenofovir-Disoproxil | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 160 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Prophylaxis for HIV-1: Tenofovir/Emtricitabine (Truvada ®) + Lopinavir/Ritonavir (Kaletra ®) vs Tenofovir/Emtricitabine/Cobicistat/Elvitegravir (Stribild ®). Prospective, Randomized, Open. |
Actual Study Start Date : | June 6, 2015 |
Actual Primary Completion Date : | July 15, 2016 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Tenofovir+emtricitabine |
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
|
Experimental: Elvitegravir/cobicistat/emtricitabine/Tenofovir-Disoproxil |
Drug: 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.
Other Name: (Stribild)
|
- 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.
- Incidence of clinical adverse events and / or laboratory alterations. [ Time Frame: 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 [ Time Frame: twenty four weeks ]
- degree of adhesion during the treatment period [ Time Frame: twenty eight days ]Measured by pill count and patient adherence questionnaire
- time to loss of adherence to TARV [ Time Frame: twenty eight days ]
- Proportion of patients with seroconversion in both treatment arms at 24 weeks follow-up. [ Time Frame: twenty four weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02198443
Spain | |
Hospital clínico y provincial de Barcelona | |
Barcelona, Spain, 08036 |
Principal Investigator: | Felipe García, MD | Hospital clínic y provincial de Barcelona |
Responsible Party: | Anna Cruceta, project manager, Fundacion Clinic per a la Recerca Biomédica |
ClinicalTrials.gov Identifier: | NCT02198443 History of Changes |
Other Study ID Numbers: |
STRIB-PEP |
First Posted: | July 23, 2014 Key Record Dates |
Last Update Posted: | February 23, 2017 |
Last Verified: | July 2014 |
Additional relevant MeSH terms:
Ritonavir Lopinavir Cobicistat Tenofovir Emtricitabine Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors |