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

HIV Infections Clinical Trial

Official title:

Multi-Center Trial to Evaluate the Efficacy and Safety of Structured Treatment Interruptions With or Without Pegylated Interferon Alpha for HIV-Infected Patients After Prolonged Viral Suppression (ANRS 105 INTERVAC)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00125814
• Other study ID #: ANRS 105 INTERVAC
• Status: Terminated
• Phase: Phase 3
• First received: August 1, 2005
• Last updated: August 15, 2005
• Start date: December 2001
• Est. completion date: January 2005

Study information

• Verified date: August 2005
• Source: French National Agency for Research on AIDS and Viral Hepatitis
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 200
• Est. completion date: January 2005
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Interferon alfa-2b

Procedure:
• Structured treatment interruptions

Locations

Country	Name	City	State
France	Service de Medecine Interne	Clamart

Sponsors (2)

Lead Sponsor	Collaborator
French National Agency for Research on AIDS and Viral Hepatitis	Schering-Plough

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients who did not reach the criteria to resume antiretroviral treatment at week 72 [W 72] (viral load over 30000 cp/ml at two consecutive monthly samples and/or CD4 count below 350/mm3 at two consecutive monthly samples)
Secondary	Viral rebound one and 3 months after stopping all antiviral treatments
Secondary	Specific anti-HIV CD4 and CD8 response
Secondary	Proviral HIV DNA at baseline and during follow-up
Secondary	Description of genetic HIV viral mutations during procedure
Secondary	Safety