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

NCT01815580 | Completed Phase 4 Results

• 2 other identifiers: TNT-PeruR01DA032106
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Keywords

HIV; Treatment as Prevention; Seek, Test, Treat, Retain Strategies

Outcome Measures

Primary Outcomes (2)

• Number of Participants With HIV Viral Load Suppression in Plasma

  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

  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 Outcomes (9)

• Sequence Clusters Identified Using Phylogenetic Analysis Among Participants With Early HIV Infection

  HIV diagnosis visit

• Percent of Participants Whose HIV Sequences Appear in Phylogenetically Defined Clusters

  HIV diagnosis visit

• Number of Participants Diagnosed With Acute HIV Infection Who Were Linked to Care

  within 3 months of diagnosis of acute HIV infection

• Partner Tracing

  within 3 months of diagnosis

• Number of Participants Retained in Care

  Baseline, Week 12, Week 24, Week 36, and Week 48

Study Arms (2)

Immediate ART (Atripla or Stribild)

ACTIVE COMPARATOR

Daily Atripla or Stribild will be provided to these patients for the duration of the study beginning at enrollment.

Drug: Atripla or Stribild

Deferred ART (Atripla or Stribild)

PLACEBO COMPARATOR

Daily Atripla or Stribild will be provided to these patients for the duration of the study beginning at 24 weeks.

Drug: Atripla or Stribild

Interventions

Atripla or Stribild DRUG

Antiretroviral therapy

Also known as: (alternate: Truvada + 3rd ARV)

Deferred ART (Atripla or Stribild); Immediate ART (Atripla or Stribild)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Prior receipt of investigational anti-HIV vaccine
• 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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• Asociación Civil Impacta Salud y Educación, Peru: collaborator
• Asociación Civil Via Libre, Peru: collaborator
• Epicentro, Peru: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Asociación Civil Impacta Salud y Educación

Lima, Peru

Location

Related Publications (3)

• Bachman VF, Montano MA, Ulrich A, Villaran M, Cabello R, Gonzalez P, Sanchez H, Lama JR, Duerr A. Correlates of condomless anal intercourse with different types of sexual partners among men who have sex with men and transgender women in Lima, Peru. AIDS Care. 2023 Jun;35(6):791-799. doi: 10.1080/09540121.2021.1994517. Epub 2021 Oct 26.

  PMID: 34702087 DERIVED

• Mayer ME, White E, Montano MA, Lama JR, Sanchez H, Cabello R, Sanchez J, Pasalar S, Duerr A. Sexual Behavior Among Men Who Have Sex With Men: The Need for More Targeted Outreach to Men Who Also Have Sex With Cisgender Women. J Acquir Immune Defic Syndr. 2021 Mar 1;86(3):265-270. doi: 10.1097/QAI.0000000000002568.

  PMID: 33148993 DERIVED

• Lama JR, Ignacio RAB, Alfaro R, Rios J, Cartagena JG, Valdez R, Bain C, Barbaran KS, Villaran MV, Pilcher CD, Gonzales P, Sanchez J, Duerr A. Clinical and Immunologic Outcomes After Immediate or Deferred Antiretroviral Therapy Initiation During Primary Human Immunodeficiency Virus Infection: The Sabes Randomized Clinical Study. Clin Infect Dis. 2021 Mar 15;72(6):1042-1050. doi: 10.1093/cid/ciaa167.

  PMID: 32107526 DERIVED

MeSH Terms

Interventions

Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Intervention Hierarchy (Ancestors)

Tenofovir; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Drug Combinations; Pharmaceutical Preparations; Cobicistat; Carbamates; Acids, Acyclic; Carboxylic Acids; Thiazoles; Sulfur Compounds; Azoles; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Ann Duerr
• Organization: Fred Hutchinson Cancer Center

aduerr@fredhutch.org

206 667 7938

Study Officials

• Ann Duerr, M.D.

  Fred Hutchinson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor (Member)

Study Record Dates

• First Submitted: March 15, 2013
• First Posted: March 21, 2013
• Study Start: July 1, 2013
• Primary Completion: November 30, 2020
• Study Completion: June 30, 2021
• Last Updated: September 29, 2022
• Results First Posted: September 29, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

PE (1)