Structured Treatment Interruptions With or Without Pegylated Interferon Alpha for HIV-Infected Patients After Prolonged Viral Suppression

French National Agency for Research on AIDS and Viral Hepatitis

Status and phase

Terminated

Phase 3

Conditions

HIV Infections

Treatments

Procedure: Structured treatment interruptions

Drug: Interferon alfa-2b

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00125814

ANRS 105 INTERVAC

Details and patient eligibility

About

The purpose of this study is to determine whether the adjunctional of interferon alfa to structured treatment interruptions correlated with a long time off treatment in HIV-1 infection.

Full description

The limitations of the drugs used against HIV include their toxicity, their tolerability, their propensity to induce resistance when not taken with absolute regularity and their cost. Treatment interruption in patients receiving antiretroviral treatment in the setting of chronic infection is associated with viral rebound and rapid CD4 T cell decrease conducting to antiretroviral therapy restart. In patients with high CD4+ cell counts (patients receiving treatment of chronic infection with controlled viremia and patients who are receiving highly active antiretroviral therapy (HAART) now in whom treatment would not have been started based on current guidelines), the investigators evaluated whether the adjunctional of interferon alfa 2b to 3 structured treatment interruptions correlated with a long time off treatment. HAART was interrupted for 4 weeks, restarted and continued for 12 weeks. After 3 such cycles treatment was indefinitely suspended 48 weeks after study entry. Another aim of this study was to assess the immunological and virological factors associated with the duration of treatment interruption (proviral HIV DNA at baseline and during follow-up, plasma HIV RNA at baseline and during follow-up, CD4 T cell and CD8 T cell HIV specific responses at baseline and after 6 months of interruption).

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Males and non pregnant females
Confirmed laboratory diagnosis of HIV infection
Have been on the same continuous HAART regimen for at least 6 months prior to inclusion
Viral load below 50 cp/ml for at least 6 months
CD4 over 350 cells/mm3
Previous viral load over 10000 cp/ml in their history
No CD4 cell count under 100/mm3 in their history
For women of reproductive ages: negative serum pregnancy test
Signed written consent to participate.