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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

F

French National Agency for Research on AIDS and Viral Hepatitis

Status and phase

Terminated
Phase 2

Conditions

HIV Infection

Treatments

Drug: IL-2
Biological: ALVAC VIH 1433
Biological: LIPO-6T

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00196651
ANRS 095 PRIMOVAC

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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