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

• Status: Terminated
• Trial end date: 2005-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3

Details

• Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis
• Collaborator: Schering-Plough
• Treatments: Interferon alpha-2; Interferon-alpha; Interferons

Criteria

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.

Exclusion Criteria:

• Already had interferon or interleukin-2 (IL-2)

• Positive hepatitis C virus (HCV) PCR

• Under treatment with abacavir during screening

• Serious psychiatric history, suicide attempt, or severe depression

• History of thyroid abnormality

• Opportunistic infection ongoing

• Lymphoma or Kaposi's sarcoma (KS) under chemotherapy