Scientists map HIV's hiding spots in early infection
NCT ID NCT03449706
First seen Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time
Summary
Researchers want to understand how HIV builds a hidden reservoir in the body when someone starts treatment during the earliest stage of infection. The study follows 70 recently infected people who begin combination antiretroviral therapy right away. Over two years, participants give blood, stool, spinal fluid, and tissue samples so scientists can track how the virus and the immune system change. The goal is to learn what keeps HIV hidden and what might one day let people stop treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- early combination antiretroviral treatment
- What this could lead to
- If researchers map how HIV hides in the body during early infection, that could point toward ways to target the viral reservoir and possibly one day allow people to pause treatment.
- What could go wrong
- This is a small observational study with 70 participants, so its findings may not apply to everyone. The sampling involves colon biopsies, lymph node removal, and lumbar punctures, which carry discomfort and small risks.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2017
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
We will enroll a minimum of 30 patients and a maximum of 70 participants (Fiebig stages I - VI) in the study to establish a cohort of early treated patients. We aim at including at least 15 people with an incomplete Western Blot (Fiebig I-\>IV) and as a control we will also include patients with complete Western Blot and history of a semi-recent infection (Fiebig V-VI).
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Documented recent HIV-1 infection, early diagnosis: clinical symptoms of acute seroconversion and incomplete Western Blot OR negative screening test within the past 6 months and incomplete Western Blot OR risk contact within the 3 months and presumable primo-infection with or without clinical symptoms and incomplete Western Blot * Able and willing to provide written informed consent * Ability to attend the complete schedule of assessments and patient visits for patients participating in option A schedule (described below), or ability to attend a partial schedule of assessments and patient visits for patients participating in option B (described below). * Ability and willingness to have blood and tissue samples collected and stored indefinitely and used for various research purposes. Exclusion Criteria: * Previous or current history of opportunistic infection (AIDS defining events as defined in category C of the CDC clinical classification), consisting of chronic HIV-1 infection. * Evidence of active HBV infection (Hepatitis B surface antigen positive or HBV viral load positive in the past and no evidence of subsequent seroconversion (=HBV antigen or viral load negative and positive HBV surface antibody). * Evidence of active HCV infection: HCV antibody positive result within 60 days prior to study entry with positive HCV viral load or, if the HCV antibody result is negative, a positive HCV RNA result within 60 days prior to study entry. * Current or known history of cardiomyopathy or significant ischemic or cerebrovascular disease. * Current history of cancer. * Pregnancy or breastfeeding. * Any conditions, including psychiatric and psychological disorders, which will in the opinion of the investigator interfere with the trial conduct or safety of the participant. * Previous participation in a trial evaluating an immune modulating agent * Abnormal laboratory tests results at screening: confirmed Hemoglobin \<11g/dl for women and \<12 g:dl for men/ confirmed platelet count \< 100000/l / confirmed neutrophil count \<1000/μl/ confirmed AST and/or ALT \> 3xULN * Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements. * Acute or serious illness, in the opinion of the site investigator, requiring systemic treatment and/or hospitalization within 60 days prior to entry.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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UZ Gent
RECRUITINGGhent, Oost-Vlaanderen, 9000, Belgium
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