Status:
COMPLETED
HIV Test and Treat to Prevent HIV Transmission Among MSM and Transgender Women
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
Asociación Civil Impacta Salud y Educación, Peru
Asociación Civil Via Libre, Peru
Conditions:
HIV
Eligibility:
MALE
18+ years
Phase:
PHASE4
Brief Summary
This study will recruit men and transgender women with acute or recent HIV infection. It wil look at how HIV medicines (ART) when given very early after HIV infection affect the amount of HIV in the b...
Detailed Description
This is three-step study. Step 1 will screen men who have sex with men (MSM) and transgender women who are unaware of their HIV status and 1) report high risk behaviors for acquiring HIV-1 infection o...
Eligibility Criteria
Inclusion
- Adult men who have sex with men, and transgender women
- Unaware of HIV status at enrollment in follow-up cohort
- High risk for HIV infection
- Willing to test for HIV
- No prior ART, including prior administration of pre- and post-exposure prophylaxis in the last 30 days
- Willing to provide informed consent
Exclusion
- Prior receipt of investigational anti-HIV vaccine
- Ongoing therapy with any of the following:
- Systemic corticosteroids. Short course less than or equal to 21 days of corticosteroids is allowed
- Systemic chemotherapeutic agents
- Nephrotoxic systemic agents, including aminoglycosides, amphotericin B, cidofovir, cisplatin, foscarnet, pentamidine
- Immunomodulatory treatments including Interleukin-2
- Investigational agents
- Known allergy/sensitivity or any hypersensitivity to components of study drugs (ART) or their formulations
- Active drug or alcohol use or dependence that would interfere with adherence to study requirements
- Serious medical or psychiatric illness that would interfere with the ability to adhere to study requirements
- Chronic or acute hepatitis B infection
- Use of female hormonal products based on estrogen or derivatives
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2021
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT01815580
Start Date
July 1 2013
End Date
June 30 2021
Last Update
September 29 2022
Active Locations (1)
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1
Asociación Civil Impacta Salud y Educación
Lima, Peru