Clinical trial NCT01815580: HIV Test and Treat to Prevent HIV Transmission Among MSM and Transgender Women
Official title: HIV Testing and Treatment to Prevent Onward HIV Transmission Among MSM and Transgender Women in Lima, Peru
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV
Keywords: HIV
Treatment as Prevention
Seek, Test, Treat, Retain Strategies
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: Asociación Civil Impacta Salud y Educación, Peru
name: Asociación Civil Via Libre, Peru
name: Epicentro, Peru
name: National Institute on Drug Abuse (NIDA)
First posted: 2013-03-21
Enrollment: 225
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With HIV Viral Load Suppression in Plasma
timeFrame: Baseline, Week 12, Week 24, Week 36, and Week 48
measure: Number of Participants With HIV Viral Load Suppression in Semen
timeFrame: Baseline, Week 12, and Week 24
Secondary outcomes:
measure: Sequence Clusters Identified Using Phylogenetic Analysis Among Participants With Early HIV Infection
timeFrame: HIV diagnosis visit
measure: Percent of Participants Whose HIV Sequences Appear in Phylogenetically Defined Clusters
timeFrame: HIV diagnosis visit
measure: Number of Participants Diagnosed With Acute HIV Infection Who Were Linked to Care
timeFrame: within 3 months of diagnosis of acute HIV infection
measure: Partner Tracing
timeFrame: within 3 months of diagnosis
measure: Number of Participants Retained in Care
timeFrame: Baseline, Week 12, Week 24, Week 36, and Week 48
measure: Adherence to ART Regimen (Percentage of Pills Taken)
timeFrame: 48 weeks
measure: Adherence to Viral Load (VL) Procedure
timeFrame: Baseline, Week 12, Week 24, Week 36, and Week 48
measure: Adherence to CD4 Procedure
timeFrame: Baseline, Week 12, Week 24, Week 36, and Week 48
measure: Adherence to Questionnaires
timeFrame: Baseline, Week 12, Week 24, Week 36, and Week 48
Other outcomes:
Locations:
city: Lima
country: Peru
facility: Asociación Civil Impacta Salud y Educación
Study officials:
affiliation: Fred Hutchinson Cancer Center
name: Ann Duerr, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.