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 - Full Text View

Sponsors and Collaborators:	French National Agency for Research on AIDS and Viral Hepatitis Aventis Pharmaceuticals
Information provided by:	French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:	NCT00196651

Purpose

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

Condition	Intervention	Phase
HIV Infection	Drug: IL-2 Biological: LIPO-6T Biological: ALVAC VIH 1433	Phase II

MedlinePlus related topics: AIDS

Drug Information available for: Interleukin-2

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	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

Further study details as provided by French National Agency for Research on AIDS and Viral Hepatitis:

Primary Outcome Measures:

Evolution of CD4-CD8 non specific and HIV specific cells, vaccinal peptids and viral load with DNA proviral at W36

Secondary Outcome Measures:

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

Estimated Enrollment:	60
Study Start Date:	August 2000
Estimated Study Completion Date:	February 2004

Detailed Description:

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.Patients treated with HAART are randomized to 3 arms:arm1 HAART alone; arm2 with 5 cycles of IL-2 at wk0 ,8 ,16 ,24 and 32;arm3 4 injections of Alvac-HIV 1433 and LIPO-6T at wk0,4,8 followed by 3 cycles of IL-2 at w 16, 24 and 32. HAART is stopped at wk 40 in patient with undetectable plasma viral load. Viral loads and HIV-specific responses are monitored during the therapeutic period and after HAART interruption until w52. HAARTis rei-initiated with viral failure.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Vaccination or chemotherapy or corticosteroid since 3 months
Evolutive cancer
pregnancy or breastfeeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00196651

Sponsors and Collaborators

French National Agency for Research on AIDS and Viral Hepatitis

Aventis Pharmaceuticals

Investigators

Principal Investigator:	Cecile Goujard, MD	Hopital Kremlin Bicetre Bicetre France
Study Director:	Jean Pierre Aboulker, MD	Inserm SC10 France

More Information

Publications indexed to this study:

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.

Study ID Numbers:	ANRS 095 PRIMOVAC
Study First Received:	September 12, 2005
Last Updated:	September 12, 2005
ClinicalTrials.gov Identifier:	NCT00196651
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:

HIV infection
AIDS Vaccines
ALVAC vaccine
Interleukin-2
Antiretroviral Therapy, Highly Active

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
Interleukin-2
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Communicable Diseases
RNA Virus Infections
Slow Virus Diseases

Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 16, 2009