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)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2014 by Fundacion Clinic per a la Recerca Biomédica.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Fundacion Clinic per a la Recerca Biomédica
Information provided by (Responsible Party):
Anna Cruceta, Fundacion Clinic per a la Recerca Biomédica
ClinicalTrials.gov Identifier:
NCT02198443
First received: July 22, 2014
Last updated: NA
Last verified: July 2014
History: No changes posted
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Purpose
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,
| Condition | Intervention | Phase |
|---|---|---|
|
HIV |
Drug: Tenofovir + emtricitabine (Truvada),+lopinavir/ritonavir (Kaletra) Drug: elvitegravir/cobicistat/emtricitabine/Tenofovir-Disoproxil |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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. |
Resource links provided by NLM:
MedlinePlus related topics:
HIV/AIDS
Drug Information available for:
Emtricitabine
Tenofovir
Ritonavir
Lopinavir
Tenofovir Disoproxil Fumarate
Elvitegravir
Truvada
Cobicistat
U.S. FDA Resources
Further study details as provided by Fundacion Clinic per a la Recerca Biomédica:
Primary Outcome Measures:
- Proportion of patients who leave the initial treatment of post-exposure prophylaxis (PEP) for HIV for any reason [ Time Frame: Twenty Eigth days ] [ Designated as safety issue: No ]
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 Outcome Measures:
- Incidence of clinical adverse events and / or laboratory alterations. [ Time Frame: twenty-four weeks ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- degree of adhesion during the treatment period [ Time Frame: twenty eight days ] [ Designated as safety issue: No ]Measured by pill count and patient adherence questionnaire
- time to loss of adherence to TARV [ Time Frame: twenty eight days ] [ Designated as safety issue: No ]
- Proportion of patients with seroconversion in both treatment arms at 24 weeks follow-up. [ Time Frame: twenty four weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 160 |
| Study Start Date: | October 2014 |
| Estimated Study Completion Date: | July 2016 |
| Estimated Primary Completion Date: | March 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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)
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02198443
Please refer to this study by its ClinicalTrials.gov identifier: NCT02198443
Contacts
| Contact: Anna cruceta, MD | 932275400 ext 4380 | acruceta@clínic.ub.es |
Locations
| Spain | |
| Hospital clínico y provincial de Barcelona | Not yet recruiting |
| Barcelona, Spain, 08036 | |
| Contact: Anna Cruceta, MD 0034932275400 ext 4380 acruceta@clínic.ub.es | |
| Sub-Investigator: Lorna Leal, MD | |
| Sub-Investigator: Agathe Leon, MD | |
Sponsors and Collaborators
Fundacion Clinic per a la Recerca Biomédica
Investigators
| Principal Investigator: | Felipe García, MD | Hospital clínic y provincial de Barcelona |
More Information
| 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 |
| Study First Received: | July 22, 2014 |
| Last Updated: | July 22, 2014 |
| Health Authority: | Spain: Agencia Española de Medicamentos y Productos Sanitarios |
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 |
ClinicalTrials.gov processed this record on September 29, 2016