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| ID | Type | Description | Link |
|---|---|---|---|
| 37384 | Other Grant/Funding Number | Merck Pharmaceuticals |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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Objective: The objective of this study is to determine the safety and tolerability of Post-exposure Prophylaxis (PEP) with a regimen of Truvada + Kaletra among health care workers (HCWs) at Henry Ford Hospital.
Hypothesis: Raltegravir is safe and better tolerated compared with Kaletra, each in combination with Truvada, as assessed by review of completion rates of PEP and also review of completed safety data.
Health Care Workers that have occupational exposure to blood are at risk for HIV infection. Prevention of blood exposure, through safer practices, barrier precautions, safer needle devices, and other innovations, is the best way to prevent infection with HIV and other bloodborne pathogens.
Though these strategies have been successful in reducing the frequency of blood exposure and needlestick injuries in the past decade, the hazard has not been eliminated. As of December 2001, the CDC had received voluntary reports of 57 documented cases of HIV seroconversion temporally associated with occupational exposure to HIV among U.S. health care personnel. An additional 138 infections among health care personnel were considered possible cases of occupational transmission. Because there is no cure or effective vaccine for HIV, optimal post exposure care, including the administration of antiretroviral drugs to prevent HIV infection, remains a high priority in protecting health care workers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kaletra | Active Comparator | Arm 1: Kaletra two tabs twice a day + Truvada one pill once a day. |
|
| Raltegravir | Active Comparator | Arm 2: Raltegravir 400 mg, one pill twice a day + Truvada one pill once a day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| emtricitabine/tenofovir disoproxil fumarate | Drug | Each health care worker will receive one of the Treatment Arms for 28 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evidence of Toxicity. Toxicity Was Measured as Any Adverse Event; Nausea, Vomiting, Diarrhea. Elevated Liver Function Tests. | Descriptive study describing toxicity between the 2 groups | Variables to be measured within 4 weeks between groups. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants That Were HIV Infected | Any patient that gets HIV infected inspite of receiving PEP will be described | HIV ELISA measured within 24 weeks between groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Indira Brar, M.D. | Henry Ford Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Kaletra | Arm 1: Kaletra two tabs twice a day + Truvada one pill once a day. emtricitabine/tenofovir disoproxil fumarate: Each health care worker will receive one of the Treatment Arms for 28 days. |
| FG001 | Raltegravir | Arm 2: Raltegravir 400 mg, one pill twice a day + Truvada one pill once a day. emtricitabine/tenofovir disoproxil fumarate: Each health care worker will receive one of the Treatment Arms for 28 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Kaletra | Arm 1: Kaletra two tabs twice a day + Truvada one pill once a day. emtricitabine/tenofovir disoproxil fumarate: Each health care worker will receive one of the Treatment Arms for 28 days. |
| BG001 | Raltegravir |
| 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 | Evidence of Toxicity. Toxicity Was Measured as Any Adverse Event; Nausea, Vomiting, Diarrhea. Elevated Liver Function Tests. | Descriptive study describing toxicity between the 2 groups | Posted | Number | adverse events | Variables to be measured within 4 weeks between groups. |
|
Adverse event data were collected for 4 weeks from commencement of PEP regimen
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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 | Kaletra | Arm 1: Kaletra two tabs twice a day + Truvada one pill once a day. emtricitabine/tenofovir disoproxil fumarate: Each health care worker will receive one of the Treatment Arms for 28 days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| other | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Indira Brar, MD | Henry Ford Health Sytem | 313-916-2565 | ibrar1@hfhs.org |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000069480 | Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| D000068898 | Raltegravir Potassium |
| C558899 | lopinavir-ritonavir drug combination |
| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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Arm 2: Raltegravir 400 mg, one pill twice a day + Truvada one pill once a day.
emtricitabine/tenofovir disoproxil fumarate: Each health care worker will receive one of the Treatment Arms for 28 days.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Number of Participants That Were HIV Infected | Any patient that gets HIV infected inspite of receiving PEP will be described | Posted | Number | participants | HIV ELISA measured within 24 weeks between groups |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 4 |
| 4 |
| EG001 | Raltegravir | Arm 2: Raltegravir 400 mg, one pill twice a day + Truvada one pill once a day. emtricitabine/tenofovir disoproxil fumarate: Each health care worker will receive one of the Treatment Arms for 28 days. | 0 | 7 | 0 | 7 | 4 | 7 |
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| 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 |
| D000068679 |
| Emtricitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |