Human Immunodeficiency Virus
Conditions
Keywords
Post exposure prophylaxis, Health Care Workers
Brief summary
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.
Detailed description
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.
Interventions
DRUGemtricitabine/tenofovir disoproxil fumarate
Each health care worker will receive one of the Treatment Arms for 28 days.
Sponsors
Merck Sharp & Dohme LLC
Henry Ford Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adult (at least 18 years of age)employees of HFH * History of occupational exposure to bodily fluids * Negative HIV test * The ability to understand a written informed consent form, which must be obtained prior to initiation of any study procedures
Exclusion criteria
* Positive pregnancy test * Females who are breastfeeding * History of renal disease * Contraindication for treating patient with components of PEP regimen * Greater than one dose of PEP medication for this exposure event
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evidence of Toxicity. Toxicity Was Measured as Any Adverse Event; Nausea, Vomiting, Diarrhea. Elevated Liver Function Tests. | Variables to be measured within 4 weeks between groups. | Descriptive study describing toxicity between the 2 groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants That Were HIV Infected | HIV ELISA measured within 24 weeks between groups | Any patient that gets HIV infected inspite of receiving PEP will be described |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 8 |
| 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. | 8 |
| Total | 16 |
Baseline characteristics
| Characteristic | Kaletra | Total | Raltegravir |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 16 Participants | 8 Participants |
| Region of Enrollment United States | 8 participants | 16 participants | 8 participants |
| Sex: Female, Male Female | 5 Participants | 9 Participants | 4 Participants |
| Sex: Female, Male Male | 3 Participants | 7 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 7 |
| other Total, other adverse events | 4 / 4 | 4 / 7 |
| serious Total, serious adverse events | 0 / 4 | 0 / 7 |
Outcome results
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
Time frame: Variables to be measured within 4 weeks between groups.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Kaletra | Evidence of Toxicity. Toxicity Was Measured as Any Adverse Event; Nausea, Vomiting, Diarrhea. Elevated Liver Function Tests. | 4 adverse events |
| Raltegravir | Evidence of Toxicity. Toxicity Was Measured as Any Adverse Event; Nausea, Vomiting, Diarrhea. Elevated Liver Function Tests. | 4 adverse events |
Secondary
Number of Participants That Were HIV Infected
Any patient that gets HIV infected inspite of receiving PEP will be described
Time frame: HIV ELISA measured within 24 weeks between groups
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Kaletra | Number of Participants That Were HIV Infected | 0 participants |
| Raltegravir | Number of Participants That Were HIV Infected | 0 participants |