DORAVIPEP: Evaluation of (Doravirine / Lamivudine / Tenofovir Disoproxil Fumarate) (Delstrigo®) as a New Strategy for Non-occupational Post Exposure Prophylaxis, a Prospective Open Label Study
Study Details
Study Description
Brief Summary
Subjects who go to emergency room for possible contact to HIV transmission receive Delstrigo as post exposition prophylaxis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Outcome Measures
Primary Outcome Measures
- Proportion of subjects with treatment completion at day 28 [28 days]
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.
Secondary Outcome Measures
- Assess the baseline characteristics associated to non-completion. [28 days]
% 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.
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subjects attending emergency room due to potential HIV exposition of either sex:
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Aged 18 years or more.
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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.
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Who after being fully informed, give their written consent to participate in the study and undergo the tests and examinations required.
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Individuals able to do follow up correctly.
Exclusion Criteria:
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Pregnant women or nursing mothers or women trying to conceive during the study period.
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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.
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Treatment with drugs that are contraindicated in the study or products that are in the investigational phase.
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Allergic reactions or intolerance to the compounds of the study treatment regiments
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department and HIV & HCV Clinical Research Unit University Hospital Nantes | Nantes | France | ||
| 2 | Hospital Clínic de Barcelona | Barcelona | Spain | 08036 |
Sponsors and Collaborators
- David Garcia Cinca
- Dr. Josep Mallolas
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DORAVIPEP