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HIV Testing and Treatment to Prevent Onward HIV Transmission Among MSM and Transgender Women in Lima, Peru

Phase 4
18 Years
Not Enrolling

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Trial Information

HIV Testing and Treatment to Prevent Onward HIV Transmission Among MSM and Transgender Women in Lima, Peru

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 or 2) who have symptoms of acute retroviral syndrome or 3) who
have a sexual partner with newly-diagnosed acute or recent HIV infection. HIV testing will
be conducted for several thousand MSM and transgender women from study opening until July
2015. In Step 2, high risk HIV-1 uninfected MSM and transgender women with high risk for
acquiring HIV will be tested at regular intervals for incident HIV-1 (using tests for HIV
p24 and/or HIV RNA). (During this period, men will receive standard HIV prevention
interventions.) In Step 3, individuals with acute or recent HIV-1 infection will be enrolled
in a 48-week randomized, open-label study of the effects of immediate vs. deferred ART on
the decay dynamics of HIV viral load in plasma, semen and rectal secretions. (ART will be
provided prior to 24 weeks for any participant in the deferred ART arm who meets initiation
criteria.) All participants will be followed for 48 weeks after which they will continue
ART from other sources.

Inclusion Criteria:

- 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 Criteria:

- Prior receipt of investigational anti-HIV vaccine

- Ongoing therapy with any of the following:

1. Systemic corticosteroids. Short course less than or equal to 21 days of
corticosteroids is allowed

2. Systemic chemotherapeutic agents

3. Nephrotoxic systemic agents, including aminoglycosides, amphotericin B,
cidofovir, cisplatin, foscarnet, pentamidine

4. Immunomodulatory treatments including Interleukin-2

5. 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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Outcome Measure:

HIV viral load

Outcome Description:

To quantify HIV viral load in plasma, semen and rectal secretions in individuals with early HIV infection in immediate versus deferred treatment groups.

Outcome Time Frame:

four years

Safety Issue:


Principal Investigator

Ann Duerr, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center


United States: Institutional Review Board

Study ID:




Start Date:

April 2013

Completion Date:

December 2016

Related Keywords:

  • HIV
  • HIV
  • Treatment as Prevention
  • Seek, Test, Treat, Retain Strategies