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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

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00196651
Enrollment
60
Registered
2005-09-20
Start date
2000-08-31
Completion date
2004-02-29
Last updated
2005-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infection

Keywords

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

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

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.

Interventions

DRUGIL-2
BIOLOGICALLIPO-6T
BIOLOGICALALVAC VIH 1433

Sponsors

Aventis Pharmaceuticals
CollaboratorINDUSTRY
French National Agency for Research on AIDS and Viral Hepatitis
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
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—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026