Phase 4 N=225 Randomized Other

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

HIV

Bottom Line

View on ClinicalTrials.gov: NCT01815580 ↗

Enrolled (actual)

225

Serious AEs

1.4%

Results posted

Sep 2022

Primary outcome: Primary: Number of Participants With HIV Viral Load Suppression in Plasma — 2; 1; 84; 8 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Atripla or Stribild (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Male
Sponsor: Fred Hutchinson Cancer Center
Primary completion: Nov 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With HIV Viral Load Suppression in Plasma	2; 1; 84; 8; 93; 18	—
PRIMARY Number of Participants With HIV Viral Load Suppression in Semen	4; 7; 21; 17; 19; 9	—
SECONDARY Sequence Clusters Identified Using Phylogenetic Analysis Among Participants With Early HIV Infection	30; 14; 57; 26; 52; 22	—
SECONDARY Percent of Participants Whose HIV Sequences Appear in Phylogenetically Defined Clusters	27	—
SECONDARY Number of Participants Diagnosed With Acute HIV Infection Who Were Linked to Care	71	—
SECONDARY Partner Tracing	—	—
SECONDARY Number of Participants Retained in Care	102; 106; 101; 105; 98; 103	>0.75
SECONDARY Adherence to ART Regimen (Percentage of Pills Taken)	93.6; 91.5	0.14
SECONDARY Adherence to Viral Load (VL) Procedure	105; 111; 98; 104; 95; 104	>0.3
SECONDARY Adherence to CD4 Procedure	103; 110; 99; 104; 97; 104	>0.12
SECONDARY Adherence to Questionnaires	100; 109; 96; 102; 95; 100	>0.22

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.

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:
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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01815580). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.