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

NCT01815580 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 225

Last updated 2022-09-29

Study results available
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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.

Conditions

Interventions

DRUG

Atripla or Stribild

Antiretroviral therapy

Sponsors & Collaborators

  • Asociación Civil Impacta Salud y Educación, Peru

    collaborator OTHER

  • Asociación Civil Via Libre, Peru

    collaborator OTHER

  • Epicentro, Peru

    collaborator UNKNOWN

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Fred Hutchinson Cancer Center

    lead OTHER

Principal Investigators

  • Ann Duerr, M.D. · Fred Hutchinson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2020-11-30
Completion
2021-06-30

Countries

  • Peru

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01815580 on ClinicalTrials.gov