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

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)
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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)
|
- 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.
- 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.

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

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
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. |
Principal Investigator: | Ann Duerr, M.D. | Fred Hutchinson Cancer Research Center |
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 |