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

September 16, 2022 updated by: Ann C Duerr, Fred Hutchinson Cancer Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

225

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Peru
      • Lima, Peru
        • Asociación Civil Impacta Salud y Educación

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • (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 Names:
  • (alternate: Truvada + 3rd ARV)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With HIV Viral Load Suppression in Plasma
Time Frame: Baseline, Week 12, Week 24, Week 36, and Week 48
To quantify HIV viral load suppression (<1000 copies/mL) in plasma at Baseline and weeks 12, 24, 36, and 48 weeks Suppressed at Baseline = HIV Viral load measured at the time of enrollment was <1000 copies/mL Suppressed at Week 12 = HIV Viral load measured 12 weeks after enrollment was <1000 copies/mL etc.
Baseline, Week 12, Week 24, Week 36, and Week 48
Number of Participants With HIV Viral Load Suppression in Semen
Time Frame: Baseline, Week 12, and Week 24
To quantify HIV viral load suppression (<1000 copies/mL) in semen at Baseline and weeks 12, and, 24 weeks
Baseline, Week 12, and Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sequence Clusters Identified Using Phylogenetic Analysis Among Participants With Early HIV Infection
Time Frame: HIV diagnosis visit
HIV present in blood samples from recently infected study participants was sequenced. Sequences that were similar to each other were grouped together in clusters. For this analysis, clusters were defined using a patristic distance threshold of 0.01, and a minimum cluster size of two.
HIV diagnosis visit
Percent of Participants Whose HIV Sequences Appear in Phylogenetically Defined Clusters
Time Frame: HIV diagnosis visit
HIV present in blood samples from recently infected study participants was sequenced. Sequences that were similar to each other were grouped together in clusters. For this analysis, clusters were defined using a patristic distance threshold of 0.01, and a minimum cluster size of two.
HIV diagnosis visit
Number of Participants Diagnosed With Acute HIV Infection Who Were Linked to Care
Time Frame: within 3 months of diagnosis of acute HIV infection
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.
within 3 months of diagnosis of acute HIV infection
Partner Tracing
Time Frame: within 3 months of diagnosis
Partner tracing and notification
within 3 months of diagnosis
Number of Participants Retained in Care
Time Frame: Baseline, Week 12, Week 24, Week 36, and Week 48
To determine the number of participants who were retained in care at weeks 12, 24, 36, and 48
Baseline, Week 12, Week 24, Week 36, and Week 48
Adherence to ART Regimen (Percentage of Pills Taken)
Time Frame: 48 weeks
To determine percentage of ART pills taken by participants randomized to immediate and deferred ART initiation.
48 weeks
Adherence to Viral Load (VL) Procedure
Time Frame: Baseline, Week 12, Week 24, Week 36, and Week 48
To determine the number of participants who had a viral load test at Baseline and weeks 12, 24, 36, and 48
Baseline, Week 12, Week 24, Week 36, and Week 48
Adherence to CD4 Procedure
Time Frame: Baseline, Week 12, Week 24, Week 36, and Week 48
To determine the number of participants who had a CD4 test at Baseline and weeks 12, 24, 36, and 48
Baseline, Week 12, Week 24, Week 36, and Week 48
Adherence to Questionnaires
Time Frame: Baseline, Week 12, Week 24, Week 36, and Week 48
To determine the number of participants who completed the Computer Assisted Self interviews (CASI) at Baseline and weeks 12, 24, 36, and 48
Baseline, Week 12, Week 24, Week 36, and Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fred Hutchinson Cancer Center

Collaborators

National Institute on Drug Abuse (NIDA)
Asociación Civil Impacta Salud y Educación, Peru
Asociación Civil Via Libre, Peru
Epicentro, Peru

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2013

Primary Completion (Actual)

November 30, 2020

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

March 15, 2013

First Submitted That Met QC Criteria

March 20, 2013

First Posted (Estimate)

March 21, 2013

Study Record Updates

Last Update Posted (Actual)

September 29, 2022

Last Update Submitted That Met QC Criteria

September 16, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TNT-Peru
  • R01DA032106 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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