Safety and Acceptability Study of Non-occupational Prophylaxis (PEP) Following Potential Exposure to HIV
| Status: | Terminated |
|---|---|
| Conditions: | HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/14/2017 |
| Start Date: | February 2012 |
| End Date: | May 2012 |
A Phase IV Open-label Evaluation of Safety, Tolerability and Patient Acceptance of Atazanavir Boosted With Ritonavir Combined With a Fixed-dose Formulation of Tenofovir DF and Emtricitabine for Non-occupational Prophylaxis Following Potential Exposure to HIV-1
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.
for the purpose of preventing HIV transmission after a high-risk sexual contact exposure in
HIV uninfected adults.
Participants are given a regimen containing TDF 300mg and FTC 200mg fixed-dose combination
tablet (TDF/FTC) once daily, and atazanavir, one 300mg tablet and one 100 mg ritonavir given
once daily,for 28 days.
tablet (TDF/FTC) once daily, and atazanavir, one 300mg tablet and one 100 mg ritonavir given
once daily,for 28 days.
Inclusion Criteria:
1. Age of 18 at time of first visit.
2. HIV uninfected on the basis of a negative HIV Rapid Test
3. 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.
Exclusion Criteria:
1. Women who are actively trying to become pregnant.
2. Pregnancy and/or Breastfeeding.
3. Known self report of Chronic Hepatitis B infection or prior antiretroviral therapy for
hepatitis B.
4. Known intolerance or allergy to study drugs.
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