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.
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
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
225
Antiretroviral therapy
Asociación Civil Impacta Salud y Educación
Lima, Peru
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.
Time frame: 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
Time frame: Baseline, Week 12, and Week 24
Sequence Clusters Identified Using Phylogenetic Analysis Among Participants With Early HIV Infection
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.
Time frame: HIV diagnosis visit
Percent of Participants Whose HIV Sequences Appear in Phylogenetically Defined Clusters
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.
Time frame: HIV diagnosis visit
Number of Participants Diagnosed With Acute HIV Infection Who Were Linked to Care
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.
Time frame: within 3 months of diagnosis of acute HIV infection
Partner Tracing
Partner tracing and notification
Time frame: within 3 months of diagnosis
Number of Participants Retained in Care
To determine the number of participants who were retained in care at weeks 12, 24, 36, and 48
Time frame: Baseline, Week 12, Week 24, Week 36, and Week 48
Adherence to ART Regimen (Percentage of Pills Taken)
To determine percentage of ART pills taken by participants randomized to immediate and deferred ART initiation.
Time frame: 48 weeks
Adherence to Viral Load (VL) Procedure
To determine the number of participants who had a viral load test at Baseline and weeks 12, 24, 36, and 48
Time frame: Baseline, Week 12, Week 24, Week 36, and Week 48
Adherence to CD4 Procedure
To determine the number of participants who had a CD4 test at Baseline and weeks 12, 24, 36, and 48
Time frame: Baseline, Week 12, Week 24, Week 36, and Week 48
Adherence to Questionnaires
To determine the number of participants who completed the Computer Assisted Self interviews (CASI) at Baseline and weeks 12, 24, 36, and 48
Time frame: Baseline, Week 12, Week 24, Week 36, and Week 48
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