Phase 4
Completed N=103
Truvada Plus Raltegravir for Nonoccupational Post-exposure Prophylaxis (nPEP)
Source: ClinicalTrials.gov NCT01214759 ↗Enrolled (actual)
103
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcomePrimary: Efficacy as Assessed by the Number of Participants Who Were HIV Positive at 6 Months — 0 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy as Assessed by the Number of Participants Who Were HIV Positive at 6 Months |
— | — |
| SECONDARY Number of Participants Exhibiting Clinical or Laboratory Abnormalities Resulting From the 28-day Exposure to the Antiretroviral Drugs Being Explored in This Study |
— | — |
| 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 |
85 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01214759). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.