Predictors of Time to Viremia With an Analytic Treatment Interruption

Withdrawn before enrolling

Conditions studied: HIV

In brief

This is a two-center study of 30 HIV-infected participants who have been on antiretroviral therapy (ART) for at least two years. Participants will be asked to undergo LN and GALT biopsies both before and after a closely monitored analytic treatment interruption (ATI).

Key facts

Study ID

NCT03033017

Run by

University of Minnesota

People needed

0

Starts

2016-07-01

Expected to finish

2019-01-01

Last updated by the study team

2017-12-04

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• HIV-infected individuals who have been on ART therapy for at least two years
• Male or Female, aged 18 years or older
• Documented evidence of CD4+ T cell count ≥ 300 cells/µl for 12 months prior to study entry
• BMI ≤ 30 or evidence by ultrasound or physical exam of peripheral inguinal lymph node(s) that is/are surgically accessible
• Documented plasma HIV RNA levels below level of quantification <20 to <40 copies RNA/mL depending on the assay) ≥ 24 months (a single measurement above the level of detection but < 200 copies/ml will be allowed)
• Willing to switch to an ART regimen consisting of dolutegravir and either tenofovir/emtricitabine or abacavir/lamivudine to avoid drugs with a long-half life that would expose the participant to a period of mono-therapy when the drugs are stopped.
• Women of child bearing potential and men with partners of child bearing potential must agree to use effective contraception during protocol
• Able to provide voluntary written consent.

You may not qualify if…

• ART was initiated during acute infection (within first 6 months of infection)
• Planning or current pregnancy or breastfeeding
• History and/or presence of any clinically significant disease or disorder, such as cardiovascular, pulmonary, renal, hepatic, neurological, gastrointestinal and psychiatric/mental disease/disorder, which, in the opinion of the enrolling physician, may put the participant at risk because of participation in the study, influence the results of the study, or affect the participant's ability to participate in the study.
• Inability to comply with study procedures per enrolling physician discretion.

Where it is running

• University of California — San Francisco, California, United States
• University of Minnesota — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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