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Grade 3 elevation in liver function tests
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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
| Gilead Sciences | INDUSTRY |
| Abbott | INDUSTRY |
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This study will evaluate how safe and tolerable a combination of taking three-drugs will be for the purpose of preventing HIV transmission after a high-risk sexual contact exposure in HIV uninfected adults.
Participants are given a regimen containing tenofovir disoproxil fumarate (TDF) 300mg and emtricitabine (FTC) 200mg fixed-dose combination tablet (TDF/FTC) once daily, and atazanavir, one 300mg tablet and one 100 mg ritonavir given once daily,for 28 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atazanavir, Ritonavir, Truvada | Other | Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir | Drug | TDF 300mg and FTC 200mg fixed-dose combination tablet (TDF/FTC) once daily, and atazanavir, one 300mg tablet and one 100 mg ritonavir given once daily |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of Regimen - Symptoms | Number of subjects who experienced moderate-to-severe symptoms on the symptom-directed physical exam at or before visit 3. | Visit 3- Day 30 |
| Safety of Regimen - Adverse Events/Serious Adverse Events Considered Related | Number of subjects who experience adverse or serious adverse events that are considered related to the use of the drug regimen at or before visit 3. | visit 3 - day 30 |
| Safety of Regimen - Unsafe Biological Test | Number of subjects who have an unsafe biological test result as part of the laboratory screen for safety levels (e.g., CBC, Creatinine, etc.) at or before visit 3. | visit 3 - day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Awareness of NPEP | Assess awareness as measured by how many participants had initially heard of NPEP prior to the incident exposure | Visit 2- Day 14 |
| Adherence Rate - Overall | Adherence to the regimen will be assessed by whether the regimen was completed as prescribed or not. χ2 tests will be used to assess differences in the proportion of both completion and adherence between participants in the current study and participants in previous studies of NPEP at Fenway Health (historical controls). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth H Mayer, MD | Fenway Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fenway Health | Boston | Massachusetts | 02215 | United States |
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| Label | URL |
|---|---|
| Fenway Health homepage | View source |
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De-identified participant data describing the adverse events will be available for review upon request
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| ID | Title | Description |
|---|---|---|
| FG000 | Atazanavir, Ritonavir, Truvada | Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir: TDF 300mg and FTC 200mg fixed-dose combination tablet (TDF/FTC) once daily, and atazanavir, one 300mg tablet and one 100 mg ritonavir given once daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Men and women who present within 72 hours of a potential non-occupational exposure to HIV-1.
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| ID | Title | Description |
|---|---|---|
| BG000 | Atazanavir, Ritonavir, Truvada | Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir: TDF 300mg and FTC 200mg fixed-dose combination tablet (TDF/FTC) once daily, and atazanavir, one 300mg tablet and one 100 mg ritonavir given once daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Safety of Regimen - Symptoms | Number of subjects who experienced moderate-to-severe symptoms on the symptom-directed physical exam at or before visit 3. | Posted | Count of Participants | Participants | Visit 3- Day 30 |
|
|
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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 | Atazanavir, Ritonavir, Truvada | Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir: TDF 300mg and FTC 200mg fixed-dose combination tablet (TDF/FTC) once daily, and atazanavir, one 300mg tablet and one 100 mg ritonavir given once daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Grade 3 elevation in liver function tests | Hepatobiliary disorders | Non-systematic Assessment | Due to the Grade 3 and Grade 4 elevations in liver function tests, the study was terminated on 22 May 2012 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| jaundice | Gastrointestinal disorders | Non-systematic Assessment |
Study terminated early as a result of Grade 3 and Grade 4 elevations in liver function tests
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kenneth Mayer | Fenway Health | 617-927-6400 | kmayer@fenwayhealth.org |
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| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| D000068679 | Emtricitabine |
| D000069480 | Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
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Open-label phase IV study of a new regimen for antiretroviral post-exposure prophylaxis
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|
| Visit 3- Day 30 |
| Prior nPEP Use | Number of participants who had used nPEP prior to participation in the study. | Visit 2- Day 14 |
| Adherence - Degree of Adherence | Number of participants who completed prescribed regimen | Visit 1- Day 28 |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Safety of Regimen - Adverse Events/Serious Adverse Events Considered Related | Number of subjects who experience adverse or serious adverse events that are considered related to the use of the drug regimen at or before visit 3. | Posted | Number | participants | visit 3 - day 30 |
|
|
|
| Primary | Safety of Regimen - Unsafe Biological Test | Number of subjects who have an unsafe biological test result as part of the laboratory screen for safety levels (e.g., CBC, Creatinine, etc.) at or before visit 3. | Posted | Count of Participants | Participants | visit 3 - day 30 |
|
|
|
| Secondary | Awareness of NPEP | Assess awareness as measured by how many participants had initially heard of NPEP prior to the incident exposure | Posted | Count of Participants | Participants | Visit 2- Day 14 |
|
|
|
| Secondary | Adherence Rate - Overall | Adherence to the regimen will be assessed by whether the regimen was completed as prescribed or not. χ2 tests will be used to assess differences in the proportion of both completion and adherence between participants in the current study and participants in previous studies of NPEP at Fenway Health (historical controls). | Posted | Count of Participants | Participants | Visit 3- Day 30 |
|
|
|
| Secondary | Prior nPEP Use | Number of participants who had used nPEP prior to participation in the study. | Posted | Count of Participants | Participants | Visit 2- Day 14 |
|
|
|
| Secondary | Adherence - Degree of Adherence | Number of participants who completed prescribed regimen | Posted | Count of Participants | Participants | Visit 1- Day 28 |
|
|
|
| 0 |
| 11 |
| 7 |
| 11 |
| 3 |
| 11 |
|
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| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |