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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-004140-30 | EudraCT Number |
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Subjects who go to emergency room for possible contact to HIV transmission receive Delstrigo as post exposition prophylaxis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Delstrigo | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delstrigo | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Who Did Not Complete the 28-day PEP Regimen | Proportion of subjects with treatment completion at day 28. Post exposition prophylaxis (PEP) non-completion is considered in cases:
| 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Type of Clinical and Laboratory Adverse Events During 28-day PEP With DOR/3TC/TDF | 28 days | |
| Assess the Baseline Characteristics Associated to Treatment Non-completion. | Baseline characteristics associated to treatment non-completion were identified using logistic regression model selecting variables in a stepwise fashion.The dependent variable was 'Have discontinuated the 28-days treatment' |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department and HIV & HCV Clinical Research Unit University Hospital Nantes | Nantes | France | ||||
| Hospital ClÃnic de Barcelona |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37539061 | Derived | Inciarte A, Ugarte A, Martinez-Rebollar M, Torres B, Fernandez E, Berrocal L, Laguno M, De la Mora L, De Lazzari E, Callau P, Chivite I, Gonzalez-Cordon A, Solbes E, Rico V, Barrero L, Blanco JL, Martinez E, Ambrosioni J, Mallolas J; DORAVIPEP Study Group. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate for Nonoccupational HIV-1 Postexposure Prophylaxis: A Prospective Open-Label Trial (DORAVIPEP). Open Forum Infect Dis. 2023 Jul 19;10(8):ofad374. doi: 10.1093/ofid/ofad374. eCollection 2023 Aug. |
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406 subjects met PEP criteria and were visited in the emergency department of Hospital ClÃnic of Barcelona.
1 subject was a screening failure. 6 subjects were excluded after the initial evalution because they didn't meet the selection criteria and/or had multiple entries.
399 subjects were included and analized in the study.
1535 subjects received PEP prescriptions between September 2020 and February 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Delstrigo | 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 Treatment will be administered 28 days maximum |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 24, 2020 |
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| 28 days |
| Incidence of Clinical and Laboratory Adverse Events During 28-day PEP With DOR/3TC/TDF | 28 days |
| Adherence to cART During 28-day PEP Regimen | Adherence to cART was assessed using the Simplified Medication Adherence Questionnaire (SMAQ) at day 7 and week 4. Non-adherence was defined based on questionnaire responses and pill count. | Day 0 to Day 28 (Week 4) |
| Proportion of Subjects That Maintain Follow-up | Absolute frequency and percentage of individuals who performed month 4 (retention rate). | Month 4 |
| Rate of HIV Seroconversion | Number of participants who tested positive for HIV during the 12-week follow-up period after completing post-exposure prophylaxis (PEP) with Delstrigo®. | Day 0 to Day 84 |
| Barcelona |
| 08036 |
| Spain |
| COMPLETED |
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| NOT COMPLETED |
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|
399 participants were analysed for baseline characteristics
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| ID | Title | Description |
|---|---|---|
| BG000 | Delstrigo | 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 Treatment will be administered 28 days maximum |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| ||||||||||||||||||||||
| Sex/Gender, Customized | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| |||||||||||||||||||||||
| Risk assesment | Count of Participants | Participants |
| |||||||||||||||||||||||
| Sexual orientation | Count of Participants | Participants |
| |||||||||||||||||||||||
| Previous PEP | Count of Participants | Participants |
| |||||||||||||||||||||||
| Hours from the exposure | Median | Inter-Quartile Range | hours |
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| Abused drugs | Count of Participants | Participants |
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| Sexual exposure | Count of Participants | Participants |
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| Previous sexually transmitted infections | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Participants Who Did Not Complete the 28-day PEP Regimen | Proportion of subjects with treatment completion at day 28. Post exposition prophylaxis (PEP) non-completion is considered in cases:
| All participants who received at least one dose of PEP (Intention-To-Treat population). | Posted | Count of Participants | Participants | 28 days |
|
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| ||||||||||||||||||||||||||
| Secondary | Type of Clinical and Laboratory Adverse Events During 28-day PEP With DOR/3TC/TDF | 123 is the total number of patients that reported AEs. 183 are the total of AE episodes overall in this 123 participants. | Posted | Count of Units | AEs | 28 days | AEs | AEs |
|
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| Secondary | Assess the Baseline Characteristics Associated to Treatment Non-completion. | Baseline characteristics associated to treatment non-completion were identified using logistic regression model selecting variables in a stepwise fashion.The dependent variable was 'Have discontinuated the 28-days treatment' | Odds Ratio (95% confidence interval) | Posted | Number | 95% Confidence Interval | Odds Ratio (95% confidence interval) | 28 days |
|
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| Secondary | Incidence of Clinical and Laboratory Adverse Events During 28-day PEP With DOR/3TC/TDF | ITT population | Posted | Count of Participants | Participants | 28 days |
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| ||||||||||||||||||||||||||||
| Secondary | Adherence to cART During 28-day PEP Regimen | Adherence to cART was assessed using the Simplified Medication Adherence Questionnaire (SMAQ) at day 7 and week 4. Non-adherence was defined based on questionnaire responses and pill count. | ITT population | Posted | Count of Participants | Participants | Day 0 to Day 28 (Week 4) |
|
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| Secondary | Proportion of Subjects That Maintain Follow-up | Absolute frequency and percentage of individuals who performed month 4 (retention rate). | All patients enrolled in the study | Posted | Count of Participants | Participants | Month 4 |
|
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| Secondary | Rate of HIV Seroconversion | Number of participants who tested positive for HIV during the 12-week follow-up period after completing post-exposure prophylaxis (PEP) with Delstrigo®. | ITT population | Posted | Count of Participants | Participants | Day 0 to Day 84 |
|
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Adverse event data were collected from Day 0 (start of treatment) through Week 12 (approximately 84 days).
The study reported a total of 183 adverse event (AE) episodes among 123 participants.
Events were categorized by system organ class: gastrointestinal (n = 63), neurological (n = 37), and infections (n = 28).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Delstrigo | 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 Treatment will be administered 28 days maximum | 0 | 399 | 0 | 399 | 123 | 399 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea, Abdominal pain | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Neurological | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Infections | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
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This was a single-arm, open-label study without a comparator group, which limits the ability to attribute outcomes solely to the intervention. Additionally, the number of participants affected per adverse event category was not specified, restricting detailed safety analysis. Follow-up rates decreased over time, potentially impacting data completeness.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alexy Inciarte | Hospital ClÃnic of Barcelona | +34932275400 | ajinciar@clinic.cat |
| Nov 28, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| Non binary |
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| Europe |
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| Asia |
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| Africa |
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| Unknown |
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| High |
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| Unknown |
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| Transexual |
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| Unknown |
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| Unknown |
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| Unknown |
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| Oral sex |
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| Use of condom |
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| Broken condom |
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| Blood contact/exchange |
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| Semen contact/exchange |
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| Unknown |
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| AEs |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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