Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01815580
Recruitment Status : Recruiting
First Posted : March 21, 2013
Last Update Posted : January 16, 2019
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

Tracking Information
First Submitted Date  ICMJE March 15, 2013
First Posted Date  ICMJE March 21, 2013
Last Update Posted Date January 16, 2019
Study Start Date  ICMJE July 2013
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01815580 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2013)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE HIV Test and Treat to Prevent HIV Transmission Among MSM and Transgender Women
Official Title  ICMJE HIV Testing and Treatment to Prevent Onward HIV Transmission Among MSM and Transgender Women in Lima, Peru
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE HIV
Intervention  ICMJE Drug: Atripla or Stribild
Antiretroviral therapy
Other Name: (alternate: Truvada + 3rd ARV)
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Atripla or Stribild
  • 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.
    Intervention: Drug: Atripla or Stribild
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 20, 2013)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE Peru
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01815580
Other Study ID Numbers  ICMJE TNT-Peru
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ann C Duerr, Fred Hutchinson Cancer Research Center
Study Sponsor  ICMJE Fred Hutchinson Cancer Research Center
Collaborators  ICMJE
  • Asociación Civil Impacta Salud y Educación, Peru
  • NGO Via Libre
  • Epicentro, Barranco District, Peru
Investigators  ICMJE
Principal Investigator: Ann Duerr, M.D. Fred Hutchinson Cancer Research Center
PRS Account Fred Hutchinson Cancer Research Center
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP