Evaluation of (Doravirine / Lamivudine / Tenofovir Disoproxil Fumarate) (Delstrigo®) as a New Strategy for Non-occupational Post Exposure Prophylaxis, a Prospective Open Label Study

Study Overview
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Brief Summary
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Subjects who go to emergency room for possible contact to HIV transmission receive Delstrigo as post exposition prophylaxis.

Official Title
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Evaluation of (Doravirine / Lamivudine / Tenofovir Disoproxil Fumarate) (Delstrigo®) as a New Strategy for Non-occupational Post Exposure Prophylaxis, a Prospective Open Label Study

Conditions
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Hiv

Intervention / Treatment
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* Drug: Delstrigo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects attending emergency room due to potential HIV exposition of either sex: Aged 18 years or more. Who have been exposed to non-occupational HIV and who meet the prerequisites for the current recommendations to begin prophylaxis post-exposition with three antiretroviral drugs. Who after being fully informed, give their written consent to participate in the study and undergo the tests and examinations required. Individuals able to do follow up correctly. Exclusion Criteria: Pregnant women or nursing mothers or women trying to conceive during the study period. Patients in whom it is known or suspected that the source case has a resistance to one of the drugs from the study treatment regimens. Treatment with drugs that are contraindicated in the study or products that are in the investigational phase. Allergic reactions or intolerance to the compounds of the study treatment regiments

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Delstrigo|Doravirine / lamivudine / tenofovir disoproxil fumarate (Delstrigo®) 100 mg doravirine, 300 mg lamivudine,300 mg tenofovir disoproxil fumarate equivalent to 245 mg de tenofovir disoproxil. 1 covered tablet for day .( will be administered 28 days maximum)|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with treatment completion at day 28 | Proportion of subjects with treatment completion at day 28. Post exposition prophylaxis non-completion is considered in cases: If the subject dies. Does not go to visits (loss of follow-up) Change or suspend the treatment under study for any reason. | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the baseline characteristics associated to non-completion. | % of non-completion patients by age, sex, sexual orientation, origin, comorbilities, previous post exposition prophylaxis treatment, previous sexual transmitted infections and use of abuse drugs. | 28 days | 
| Incidence and description of adverse reactions(clinical and laboratory) that appear during antiretroviral therapy |  | 28 days | 
| Description of adherence to combination antiretroviral therapy, including the time until loss of adherence |  | 28 days | 
| Proportion of subjects that maintain follow-up |  | 12 weeks | 
| Rate of HIV Seroconversion |  | 12 weeks |