View Clinical Trial (Medical Research Study)
A Pilot Project to Assess the Safety and Tolerability of Truvada Plus Raltegravir as Post-exposure Prophylaxis (nPEP) Following Sexual Exposure to Human Immunodeficiency Virus (HIV)
| City: |
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Houston |
| State: |
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Texas |
| Zip Code: |
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77030 |
| Conditions: |
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HIV |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT01214759 |
| Primary Contact: |
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Principal Investigator
Karen J Vigil, MD
The University of Texas Health Science Center, Houston
Karen J Vigil, MD
Phone: 713-500-6703
Email: Karen.J.Vigil@uth.tmc.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Houston, Texas 77030
United States
Karen J Vigil, MD
Phone: 713-500-6703
Email: Karen.J.Vigil@uth.tmc.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 19, 2013 |
| Modifications to this listing: |
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