HIV Test and Treat to Prevent HIV Transmission Among MSM and Transgender Women

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

225 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2021-06-30

Brief Summary

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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 blood, semen and rectal secretions. In addition, Investigators will be using modeling studies to look at whether or not this kind of HIV treatment can decrease the risk that a man will infect a person he has sex with and to find out how failure to take medications will impact spreading the virus to other people.

In this study, one group will be randomized (like a coin toss) to start ART immediately (just at the time of the enrollment visit) and the other group will wait until week 24 of the study to start ART. Both groups will be followed for a total of 48 weeks and will continue to receive ART from local sources after the study is over.

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Detailed Description

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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.

Conditions

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HIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Immediate ART (Atripla or Stribild)

Daily Atripla or Stribild will be provided to these patients for the duration of the study beginning at enrollment.

Group Type ACTIVE_COMPARATOR

Atripla or Stribild

Intervention Type DRUG

Antiretroviral therapy

Deferred ART (Atripla or Stribild)

Daily Atripla or Stribild will be provided to these patients for the duration of the study beginning at 24 weeks.

Group Type PLACEBO_COMPARATOR

Atripla or Stribild

Intervention Type DRUG

Antiretroviral therapy

Interventions

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Atripla or Stribild

Antiretroviral therapy

Intervention Type DRUG

Other Intervention Names

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(alternate: Truvada + 3rd ARV)

Eligibility Criteria

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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 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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes