NCT06016114Not yet recruiting
Analysis of the Reservoir in Individuals Controlling HIV Infection
Source: ClinicalTrials.gov · Last updated 19 Sept 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The aim of this study is the gain new insights into HIV latency in HIV controllers through extensive blood an tissue sampling (lymph node, colon biopsies, placenta) from 25 individuals living with HIV and healthy individuals.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 25 (estimated)
- First submitted
- 23 Aug 2023
- Start date
- Dec 2024
- Primary completion date
- Oct 2028
- Lead sponsor
- University Hospital, Ghent
- Diseases
- HIV
- NCT number
- NCT06016114
What you commit to
- Study type: Observational
- Planned participants: 25
- From Dec 2024 to the primary completion date, Oct 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
- 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.
- The following treatment will be prohibited three months before screening and during the study:
- immunosuppressive drugs (inclusive corticosteroids) except for drugs used for topical use.
- Immunomodulatory drugs including but not limited to Granulocyte-colony stimulating factors, Granulocyte-monocyte colony-stimulating factor, interleukin 2, 7 \& 15.
Other illness
- 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)).
- Current or known history of cardiomyopathy or significant ischemic or cerebrovascular disease.
- Current history of cancer.
- History of HIV-related thrombocytopenia.
- Any condition, including preexisting psychiatric and psychological disorders, which will in the opinion of the investigator interfere with the trial conduct or safety of the participant.
Lab values
- Abnormal results of standard of care laboratory tests:
- Confirmed haemoglobin \<11g/dl for women and \<12 g/dl for men
- Confirmed platelet count \<100 000/µl \*
- Confirmed neutrophil count \<1000/μl
- Confirmed AST and/or ALT \>10xULN
Who the study is looking for
- Elite Controllers: pVL\<50 copies per ml for at least 12 months, treatment naive at the time of inclusion
- Viral controllers: pVL \<2000 copies/ml; CD4\>500/µL for at least two years, treatment naïve at the time of inclusion
- Long-term non-progressors: CD4\>500/µL, pVL \<10000 copies/ml, for at least 7 years, treatment naïve at the time of inclusion
- Post treatment controllers: on cART for at least 12 months; pVL \<500 copies/ml for at least 2 years after treatment cessation .
- PLWH who received bone marrow transplant: people living with HIV who received a bone-marrow transplant for non-HIV related reasons
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.