HIV Immune and Virological Responses Following the Administration of IL-2 Either Alone or Combined to ALVAC-HIV 1433 and HIV Lipopeptides in Patients Treated Early With HAART During Primary Infection
Randomized Study on HIV Immune and Virological Responses Following the Administration of IL-2 Either Alone or Combined to ALVAC-HIV 1433 and HIV Lipopeptides (LIPO-6T) in Patients Treated Early With HAART During Primary Infection. ANRS 095 PRIMOVAC
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
HIV-specific immune responses are preserved in patients treated early during primary infection.The trial evaluated whether the addition to HAART of IL-2 alone or combined with an immunization procedure might enhance HIV immune responses and improve viral control after HAART discontinuation
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2000
Typical duration for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2000
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedSeptember 20, 2005
September 1, 2005
September 12, 2005
September 12, 2005
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evolution of CD4-CD8 non specific and HIV specific cells, vaccinal peptids and viral load with DNA proviral at W36
Secondary Outcomes (4)
Safety of IL-2, ALVAC and LIPO-6T
Tolerability of HAART
Kinetic of viral load rebound with frequency and delay of cv over 10 000 cp and 50 000 cp
Evolution on immune response and predictive value of immunologic parameters on viral load
Interventions
Eligibility Criteria
You may qualify if:
- History of symptomatic HIV primary infection with p24 positive or incomplete Western Blot
- Treatment beginning before 4W after the first primary infection serology
- HAART with IP or NNRTI since one year, wtih no change since 3 months
- Viral load below 50 cp since 6 months
- PN over 1000/mm3;Hb over 10.5g/l;Platelets over 75000/mm3, creatinine below 1.5N; transaminases below 2.5N
You may not qualify if:
- Vaccination or chemotherapy or corticosteroid since 3 months
- Evolutive cancer
- pregnancy or breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Goujard C, Marcellin F, Hendel-Chavez H, Burgard M, Meiffredy V, Venet A, Rouzioux C, Taoufik Y, El Habib R, Beumont-Mauviel M, Aboulker JP, Levy Y, Delfraissy JF; PRIMOVAC-ANRS 095 Study Group. Interruption of antiretroviral therapy initiated during primary HIV-1 infection: impact of a therapeutic vaccination strategy combined with interleukin (IL)-2 compared with IL-2 alone in the ANRS 095 Randomized Study. AIDS Res Hum Retroviruses. 2007 Sep;23(9):1105-13. doi: 10.1089/aid.2007.0047.
PMID: 17919105DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cecile Goujard, MD
Hopital Kremlin Bicetre Bicetre France
- STUDY DIRECTOR
Jean Pierre Aboulker, MD
Inserm SC10 France
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 20, 2005
Study Start
August 1, 2000
Study Completion
February 1, 2004
Last Updated
September 20, 2005
Record last verified: 2005-09