Phase 4
N=100
HIV Non Occupational Post-Exposure Prophylaxis (PEP)
HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT00594646 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Sep 2015
Primary outcome: Primary: Medication Regimen Completion Rates — 57; 28; 15 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- TRUVADA + Raltegravir (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Fenway Community Health
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Medication Regimen Completion Rates |
57; 28; 15 | — |
| PRIMARY Number of HIV-1 Infected Participants |
— | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00594646). 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.