HIV
Conditions
Keywords
HIV, prevention, prophylaxis, Raltegravir, Truvada
Brief summary
This study will evaluate the safety and tolerability of the combination of truvada and raltegravir given for 28 days for the prevention of HIV infection.
Detailed description
Non-Occupational Post-Exposure Prophylaxis (nPEP) after sexual exposure to HIV is recommended by the Centers for Disease Control (CDC). Although no efficacy data exist for Post-Exposure Prophylaxis (PEP) after sexual exposure, PEP has been shown to reduce HIV transmission in other exposure situations such as occupational exposures and mother-to-child transmission. The role in nPEP of the newer agents approved for the treatment of HIV infection remains unknown. The anti-HIV drug raltegravir works early in the life cycle of the virus, before it integrates with human DNA. It has few side effects and drug interactions what makes it an ideal drug for an nPEP regimen. We aim to asses the safety and tolerability of the combination of truvada and raltegravir for nPEP.
Interventions
DRUGTruvada
Tenofovir 200mg/emtricitabine 300mg once a day
DRUGRaltegravir
Raltegravir 400mg twice a day
Sponsors
Merck Sharp & Dohme LLC
Gilead Sciences
The University of Texas Health Science Center, Houston
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
No
Inclusion criteria
* Patients must be at least 18 years of age * HIV uninfected on the basis of a negative HIV rapid test, EIA or Western blot, and without any signs or symptoms of acute HIV infection * Able to understand and provide consent * High-Risk Exposure Characteristic (One or more of the below, unprotected or with failed condom use): * Receptive Anal Intercourse * Insertive Anal Intercourse * Receptive Vaginal Intercourse * Insertive Vaginal Intercourse * Receptive Oral Intercourse with Intraoral Ejaculation with known HIV+ source * High-Risk Source (One or more of the below): * Known HIV positive * MSM * MSM/W * CSW * Sexual perpetrator Partner of one of the above * Exposure within 72 hours of presentation * Not known to be HIV-1 positive * No countermanding concomitant medications or allergies
Exclusion criteria
* Patients \<18 years of age * Unable to understand and provide consent * Non-occupational exposure to HIV-1 not recent enough to commence the first dose of study medication within 72 hours from the exposure * Known to be HIV positive * Any condition which in the opinion of the intake provider will seriously compromise the patient's ability to comply with the protocol, including adherence to nPEP medication * Demonstrated HIV-1 positive on rapid testing * Unwillingness to commit to barrier-method (male and/or female condom) use until HIV negative status is confirmed 6 months after exposure * Unwillingness of breast-feeding women to transition to formula feeding * Any active psychiatric illness or active drug or alcohol abuse that, in the opinion of the investigator, could prevent compliance with study procedures * Pregnancy * Chronic hepatitis B infection, diagnosed by either positive serum HBsAg or positive serum HBV DNA; or prior lamivudine or other therapy for hepatitis B * Creatinine clearance less than 30 mL/min as calculated by Cockcroft-Gault formula * Unwillingness to participate in study procedures, including Mental Health referral and intervention * Known intolerance or allergy to tenofovir DF, emtricitabine or raltegravir * Use of prohibited concomitant medication: dilantin, phenobarbital and rifampin which cannot be used with raltegravir
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy as Assessed by the Number of Participants Who Were HIV Positive at 6 Months | 6 months | This measure assesses whether the combination of Truvada and Raltegravir prevents the acquisition of HIV at six months among HIV-negative people who have been exposed to HIV. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Exhibiting Clinical or Laboratory Abnormalities Resulting From the 28-day Exposure to the Antiretroviral Drugs Being Explored in This Study | 28 days | Participants who experienced side effects categorized as grade 3 or higher by the Division of AIDS table for grading the severity of adult and pediatric adverse events were tested for clinical or laboratory abnormalities. |
| Safety and Tolerability as Assessed by the Number of Participants Who Completed the 28-day Course of the Antiretroviral Drugs Being Explored in This Study | 28 days | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Truvada and Raltegravir Single arm
Truvada: Tenofovir 200mg/emtricitabine 300mg once a day
Raltegravir: Raltegravir 400mg twice a day | 103 |
| Total | 103 |
Baseline characteristics
| Characteristic | Truvada and Raltegravir |
|---|---|
| Age, Continuous | 32 years STANDARD_DEVIATION 8.9 |
| Region of Enrollment United States | 103 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 92 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 8 / 85 |
| serious Total, serious adverse events | 0 / 85 |
Outcome results
Primary
Efficacy as Assessed by the Number of Participants Who Were HIV Positive at 6 Months
This measure assesses whether the combination of Truvada and Raltegravir prevents the acquisition of HIV at six months among HIV-negative people who have been exposed to HIV.
Time frame: 6 months
Population: All who completed all study visits
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Truvada and Raltegravir | Efficacy as Assessed by the Number of Participants Who Were HIV Positive at 6 Months | 0 participants |
Secondary
Number of Participants Exhibiting Clinical or Laboratory Abnormalities Resulting From the 28-day Exposure to the Antiretroviral Drugs Being Explored in This Study
Participants who experienced side effects categorized as grade 3 or higher by the Division of AIDS table for grading the severity of adult and pediatric adverse events were tested for clinical or laboratory abnormalities.
Time frame: 28 days
Population: Only participants who experienced side effects categorized as grade 3 or higher by the Division of AIDS table were tested for clinical or laboratory abnormalities, and since no participants experienced side effects greater than grade 1, no participants were tested for clinical or laboratory abnormalities.
Secondary
Safety and Tolerability as Assessed by the Number of Participants Who Completed the 28-day Course of the Antiretroviral Drugs Being Explored in This Study
Time frame: 28 days
Population: All who were enrolled
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Truvada and Raltegravir | Safety and Tolerability as Assessed by the Number of Participants Who Completed the 28-day Course of the Antiretroviral Drugs Being Explored in This Study | 85 participants |