Status:
COMPLETED
123I Radiolabeled 3BNC117
Lead Sponsor:
University of Lausanne Hospitals
Conditions:
Human Immunodeficiency Virus
Eligibility:
All Genders
18-55 years
Phase:
EARLY_PHASE1
Brief Summary
The conventional way to control HIV infection is the usage of a drug cocktail capable of suppressing the viral replication cycle, commonly known as antiretroviral therapy (ART). Despite effective ART ...
Detailed Description
The conventional way to control HIV infection is by use of a cocktail of drugs capable of suppressing the viral replication cycle, commonly known as antiretroviral therapy (ART). Despite effective ART...
Eligibility Criteria
Inclusion
- Subject newly diagnosed with HIV in a chronic phase requiring the introduction of an antiretroviral treatment (ART)
- Age 18 to 55
- HIV-1 infection confirmed by ELISA and immunoblot
- Plasma HIV-1 RN/A \> 5000 copies/ml
- Current CD4 cell count \> 200 cells/μl
- Ability and willingness to provide written informed consent
Exclusion
- Primary infected HIV
- Currently on ART
- Participation in another clinical study of an investigational product currently or within past 30 days
- Pregnancy or lactation;
- History of systemic corticosteroids, immunosuppressive anti-cancer, or other medications considered significant by the trial physician within the last 6 months;
- Patient report, or chart history, of significant coronary artery disease, myocardial infarction, percutaneous coronary intervention with placement of cardiac stents;
- Uncontrolled hypertension, as defined by a systolic blood pressure \> 180 and/or diastolic blood pressure \> 120, in the presence or absence of anti-hypertensive medications;
- Any other clinically significant acute or chronic medical condition, such as autoimmune diseases, that in the opinion of the investigator would preclude participation;
- Laboratory abnormalities in the parameters listed below:
- Absolute neutrophil count ≤1 G/l
- Hemoglobin ≤ 10 gm/dL
- Platelet count ≤125 G/l
- ALT ≥ 2.0 x ULN
- AST ≥ 2.0 x ULN
- Total bilirubin ≥ 1.5 ULN
- Creatinine ≥ 1.1 x ULN
- Coagulation parameters ≥ 1.5 x ULN
Key Trial Info
Start Date :
February 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 28 2020
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03468582
Start Date
February 8 2018
End Date
January 28 2020
Last Update
January 29 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, Switzerland, 1011