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HIV Test and Treat to Prevent HIV Transmission Among MSM and Transgender Women (SABES?)

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ClinicalTrials.gov Identifier: NCT01815580
Recruitment Status : Recruiting
First Posted : March 21, 2013
Last Update Posted : September 1, 2017
Sponsor:
Collaborators:
Asociación Civil Impacta Salud y Educación, Peru
NGO Via Libre
Epicentro, Barranco District, Peru
Information provided by (Responsible Party):
Ann C Duerr, Fred Hutchinson Cancer Research Center

Study Description
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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 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.


Condition or disease Intervention/treatment Phase
HIV Drug: Atripla or Stribild Phase 4

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 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: HIV Testing and Treatment to Prevent Onward HIV Transmission Among MSM and Transgender Women in Lima, Peru
Study Start Date : July 2013
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Atripla
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Immediate ART (Atripla or Stribild)
Daily Atripla or Stribild will be provided to these patients for the duration of the study beginning at enrollment.
 Drug: Atripla or Stribild
Antiretroviral therapy
Other Name: (alternate: Truvada + 3rd ARV)
Placebo Comparator: 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.
 Drug: Atripla or Stribild
Antiretroviral therapy
Other Name: (alternate: Truvada + 3rd ARV)


Outcome Measures
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Primary Outcome Measures :
  1. HIV viral load [ Time Frame: four years ]
    To quantify HIV viral load in plasma, semen and rectal secretions in individuals with early HIV infection in immediate versus deferred treatment groups.


Secondary Outcome Measures :
  1. Risk factors for acute/recent HIV infection [ Time Frame: four years ]
    To identify risk factors associated with incident HIV-1 infection among MSM and transgender women in Peru.

  2. Linkage to care [ Time Frame: four years ]
    To determine the proportion of individuals with evidence of acute infection (HIV-1 RNA-positive) who are successfully contacted for confirmatory HIV testing and are then linked to care.

  3. Retention in care [ Time Frame: four years ]
    To determine the proportion of men retained in care, including adherence to ART and study procedures, among individuals with early HIV-1 infection receiving immediate and deferred ART.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01815580


Locations
Peru
Asociación Civil Impacta Salud y Educación Recruiting
Lima, Peru
Contact: Javier Lama, M.D.    511-206-7800 ext 407    jrlama@impactaperu.org   
Principal Investigator: Javier Lama, M.D.         
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Asociación Civil Impacta Salud y Educación, Peru
NGO Via Libre
Epicentro, Barranco District, Peru
Investigators
Principal Investigator: Ann Duerr, M.D. Fred Hutchinson Cancer Research Center
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Ann C Duerr, Professor (Member), Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT01815580     History of Changes
Other Study ID Numbers: TNT-Peru
First Posted: March 21, 2013    Key Record Dates
Last Update Posted: September 1, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Ann C Duerr, Fred Hutchinson Cancer Research Center:
HIV
Treatment as Prevention
Seek, Test, Treat, Retain Strategies

Additional relevant MeSH terms:
Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents