HIV Infections
Conditions
Keywords
HIV Prevention, Non-occupational post-exposure prophylaxis, HIV seronegativity
Brief summary
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.
Detailed description
This study will evaluate a three drug regimen in the form of two pills which will be taken for 28 days for the prevention of HIV infection. Two drugs are combined in an FDA-approved pill called TRUVADA, containing the HIV medications, tenofovir disoproxil fumarate 300mg and emtricitabine 200mg, taken as one pill once a day. The third drug is a new formulation, raltegravir 400mg pill taken twice a day.
Interventions
DRUGTRUVADA + Raltegravir
TRUVADA (tenofovir disoproxil fumarate (DF) 300mg + emtricitabine 200mg) + RALTEGRAVIR 400mg
Sponsors
Merck Sharp & Dohme LLC
Fenway Community Health
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
* HIV uninfected on the basis of a negative HIV Rapid Test, EIA or Western blot, and a negative HIV-1 RNA assay * Possible non-occupational exposure to HIV-1, recent enough to permit receiving the first dose of study medication within 72 hours from the end of the exposure. * Able to understand the study procedures and willing to sign informed consent
Exclusion criteria
* 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 therapy for hepatitis B. * Creatinine clearance less than 50 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 |
|---|---|---|
| Number of HIV-1 Infected Participants | 90 days | Of participants that were evaluable at 3 months post initiation of treatment, how many became HIV-1 infected |
| Medication Regimen Completion Rates | 28 days | Pill counts performed at 14 and 28 days |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from Fenway Health. Patients at least 18 years of age, who contacted Fenway Health and presented within 72 hours after a potential sexual exposure to HIV-1 were asked to participate in this study.
Pre-assignment details
If study coordinator is notified more than 72 hours after exposure occurred, person will not be eligible for study participation; however they will be referred to an on call medical provider for Non Occupational Post-Exposure Prophylaxis evaluation.
Participants by arm
| Arm | Count |
|---|---|
| Group 1 TRUVADA (tenofovir DF 300mg + emtricitabine 200mg) + raltegravir (400mg) | 100 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 15 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Group 1 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 100 Participants |
| Age, Continuous | 33.3 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants |
| Race (NIH/OMB) More than one race | 13 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 71 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 | — / — |
| other Total, other adverse events | 93 / 100 |
| serious Total, serious adverse events | 0 / 100 |
Outcome results
Primary
Medication Regimen Completion Rates
Pill counts performed at 14 and 28 days
Time frame: 28 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 | Medication Regimen Completion Rates | Completed as prescribed | 57 participants |
| Group 1 | Medication Regimen Completion Rates | Stopped or Modified regimen | 28 participants |
| Group 1 | Medication Regimen Completion Rates | Lost to follow-up | 15 participants |
Primary
Number of HIV-1 Infected Participants
Of participants that were evaluable at 3 months post initiation of treatment, how many became HIV-1 infected
Time frame: 90 days
Population: Participants evaluable at 3 months (90 days) after treatment initiation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 | Number of HIV-1 Infected Participants | 0 participants |