Human Immunodeficiency Virus
Conditions
Keywords
HIV, PEP, nPEP, Prophylaxis, Post Exposure Prophylaxis, exposure to HIV, HIV prevention
Brief summary
The purpose of this study is to see if an anti-HIV medication known as Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir DF) is safe, tolerable and acceptable when taken for 28 days, once a day after a possible, sexual, exposure to the Human Immune Deficiency Virus (HIV).
Detailed description
Stribild is a combination of 1 integrase strand transfer inhibitor, 1 pharmacokinetic enhancer, and 2 nucleos(t)ide analog HIV-1 reverse transcriptase inhibitors, and was approved in August 2012, as a complete treatment regimen for HIV-1 infection in adults who are antiretroviral treatment-naïve. We are proposing to evaluate the safety, tolerability and acceptability of Stribild given to participants over age 18 after a possible sexual exposure to HIV-1. Enrolled participants will have experienced a moderate to high risk exposure, as outlined in the study protocol, within the last 72 hours - per 2005 Center for Disease Control and Prevention guidelines. Participants will take one Stribild tablet, by mouth, once a day for 28 days. Study staff will assess for changes in blood chemistries and clinical signs and symptoms from baseline health. Study participation is 90 days and will include HIV testing, STI screening, HIV/STI risk reduction counseling, clinical assessments, blood draws and surveys designed to gather knowledge and perception of HIV post-exposure prophylaxis (PEP) and HIV pre-exposure prophylaxis (PrEP). Conditional referrals to continued HIV/STI risk reduction counseling and testing will be made if risk remains high at study termination. In addition, participants will be connected to a medical provider if risk demonstrates a potential need for HIV pre-exposure prophylaxis.
Interventions
DRUGSingle Dose Elivitegravir (150mg), Combicistat (150mg), Emtricitabine (200mg), Tenofovir DF (300mg)
Sponsors
Gilead Sciences
Kenneth H. Mayer, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* \> Age of 18 at time of first visit. * HIV uninfected on the basis of a negative HIV Rapid Test * Willing and able to provide written informed consent. * Willing and able to provide adequate locator information. * Willing and able to return to all study visits. * Willing to participate in all study procedures. * Biologic women of childbearing potential: Willing to use contraception for as long as they are on study medication plus 7 days after. * Possible sexual exposure to HIV-1, recent enough to permit receiving the first dose of study medication within 72 hours from the end of the exposure. possible exposure could include: 1. Unprotected anal, vaginal, oral, or mucosal (e.g. conjunctival) exposure to ejaculate from a partner who is HIV-1 infected or high risk for HIV infection and of unknown HIV-1 serostatus (may include protected sexual exposure with condom failure, breakage or slippage); or 2. Unprotected penile exposure to cervicovaginal secretions or anorectal secretions from a partner who is HIV-1 infected or high risk for HIV infection and of unknown HIV-1 serostatus (may include protected sexual exposure with condom failure, breakage or slippage)
Exclusion criteria
* An active psychiatric illness or active drug or alcohol abuse that, in the opinion of the investigator, could prevent compliance with study procedures. * Pregnancy and/or Breastfeeding. * Biologic women who are actively trying to become pregnant. * Acute or Chronic Hepatitis B infection, by history * Acute or Chronic Renal Disease, by history * Creatinine Clearance at or below 70mL/min (Cockcroft-Gault equation, Actual Weight) * Known intolerance or allergy to tenofovir DF, emtricitabine, elvitegravir or cobicistat * Currently taking or plans to take prohibited medication while enrolled in the study. * Prohibited Medications\* * Propulsid (Cisapride) * UroXatral (Alfuzosin) * Dihydroergotamine * Ergotamine * Methylergonovine * St John's Wort (Hypericum perforatum) * Altocor, Altoprev, Mevacor (Lovastatin) * Zocor (Simvastatin) * Orap (Pimozide) * Rifadin, Rimactane (Rifampin) * Viagra (Sildenafil when dosed as REVATIO) * Halcion (Triazolam) * Versed (Midazolam) (when administered orally) * Antiretroviral medications used to treat or prevent HIV infection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Event Occurrences | 90 days | The number of adverse events reported |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Self-Reported Missed Doses | Day 30 | self-reported missed doses |
Other
| Measure | Time frame | Description |
|---|---|---|
| nPEP Failure (HIV Infection During Study Participation) | 90 days | nPEP failure, meaning HIV infection during study participation, as measured during HIV testing at day 0, day 30 and day 90 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Stribild Coformulated Elivitegravir (150mg), Combicistat (150mg), Emtricitabine (200mg), Tenofovir DF (300mg) taken for 28 days, within 72 hours of a possible sexual exposure to HIV
Coformulated Elivitegravir (150mg), Combicistat (150mg), Emtricitabine (200mg), Tenofovir DF (300mg) | 100 |
| Total | 100 |
Baseline characteristics
| Characteristic | Stribild |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 100 Participants |
| Age, Continuous | 34.1 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 88 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 8 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 83 Participants |
| Region of Enrollment United States | 100 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 98 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 100 |
| other Total, other adverse events | 91 / 100 |
| serious Total, serious adverse events | 0 / 100 |
Outcome results
Primary
Number of Adverse Event Occurrences
The number of adverse events reported
Time frame: 90 days
Population: 100 participants were enrolled
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stribild | Number of Adverse Event Occurrences | Diarrhea | 38 events |
| Stribild | Number of Adverse Event Occurrences | Fatigue | 28 events |
| Stribild | Number of Adverse Event Occurrences | Nausea/Vomiting | 28 events |
| Stribild | Number of Adverse Event Occurrences | Headache | 14 events |
| Stribild | Number of Adverse Event Occurrences | Dizziness/Lightheadness | 6 events |
| Stribild | Number of Adverse Event Occurrences | Body Aches/Muscle and Joint Pain | 2 events |
Secondary
Number of Participants With Self-Reported Missed Doses
self-reported missed doses
Time frame: Day 30
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stribild | Number of Participants With Self-Reported Missed Doses | 29 Participants |
Comparison: using historical controlsp-value: <0.05Chi-squared
Other Pre-specified
nPEP Failure (HIV Infection During Study Participation)
nPEP failure, meaning HIV infection during study participation, as measured during HIV testing at day 0, day 30 and day 90
Time frame: 90 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stribild | nPEP Failure (HIV Infection During Study Participation) | 0 reactive test |