Status:
COMPLETED
Towards HIV Functional Cure
Lead Sponsor:
Objectif Recherche Vaccins SIDA
Collaborating Sponsors:
Fondation Bettencourt-Schueller
Conditions:
Chronic HIV-1 Infection
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
During the ERAMUNE-01 and -02 studies, the HIV-DNA quantification in the PBMCs (Peripheral Blood Mononuclear Cells) showed showed that some patients had a very low or undetectable reservoir. Recent s...
Eligibility Criteria
Inclusion
- HIV-1 infected patient
- CD4 count \> 500 cells/mm3
- CD4/CD8 ratio \> 0.9
- CD4 nadir \> 300 cells/mm3
- HIV-1-RNA plasma viral load \< 50 copies/mL under antiretroviral treatment for at least 2 years
- HIV-1-RNA plasma viral load \< 20 copies/mL at baseline
- HIV-DNA reservoir \< 100 copies/million PBMCs
- Signed fully informed consent form
- Ability to attend the complete schedule of assessments and patient visits
- Patient eligible for national social insurance
Exclusion
- Medical history of AIDS-staging event
- Antiretroviral treatment initiated during primo-infection in absence of anti-HIV antibodies (negative ELISA and Western Blot tests)
- Change in the antiretroviral treatment combination within the 3 months prior inclusion
- HIV-2 co-infection
- History of thrombocytopenia (\< 100 000 cells/mm3)
- Acute neurologic event during primo-infection
- Chronic and active hepatitis B as defined as positive HBs antigen or positive isolated anti-HBc antibodies
- Chronic and active hepatitis C as defined as positive anti-HCV antibodies and positive HCV-RNA PCR
- History of cancer within the 5 years prior inclusion except basocellular cutaneous cancers
- Comorbidity associated to lifespan \< 12 months according investigator's opinion
- History of auto-immune disease (lupus erythematous, Hashimoto's thyroiditis, ...)
- Hemoglobin \< 7 g/dL, Creatinine clearance \< 60 mL/min using the MDRD formula
- Patients refusal to use a condom for any sexual relationship during the course of the study
- Refusal from women of childbearing potential to use at least one additional barrier method other than condoms
- Ongoing pregnancy as documented by a positive blood test performed at screening or later
- Lactating woman
- Psychologic unstability or patient state-of-mind incompatible with the participation in the study as evaluated by psychologist at screening
- Drug or alcohol addiction or abuse
- Concomitant participation to another trial involving any investigational treatment or device
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01876862
Start Date
September 1 2013
End Date
July 1 2015
Last Update
September 29 2015
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospital of Bicêtre
Le Kremlin-Bicêtre, France, 94275
2
Hospital Pitié-Salpêtrière
Paris, France, 75013