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

Study Description

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Brief 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.

Condition or disease	Intervention/treatment	Phase
HIV Infections	Drug: Interferon alfa-2b; Procedure: Structured treatment interruptions	Phase 3

Detailed 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).

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	200 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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)
Study Start Date :	December 2001
Study Completion Date :	January 2005

Arms and Interventions

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Outcome Measures

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Primary Outcome Measures :

1. 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 Outcome Measures :

1. Viral rebound one and 3 months after stopping all antiviral treatments
2. Specific anti-HIV CD4 and CD8 response
3. Proviral HIV DNA at baseline and during follow-up
4. Description of genetic HIV viral mutations during procedure
5. Safety

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All

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

Contacts and Locations

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Locations

France
Service de Medecine Interne
Clamart, France, 92140

Sponsors and Collaborators

French National Agency for Research on AIDS and Viral Hepatitis

Schering-Plough

Investigators

Principal Investigator:	François Boue, MD	Hopital Antoine Beclere service de Medecine Interne Clamart France
Study Chair:	Dominique Costagliola	INSERM U 720

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00125814 History of Changes
Other Study ID Numbers:	ANRS 105 INTERVAC
First Posted:	August 2, 2005
Last Update Posted:	August 16, 2005
Last Verified:	August 2005

Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:

Interferon Alfa-2b; HIV infections

Additional relevant MeSH terms:

HIV Infections; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Immunologic Deficiency Syndromes	Immune System Diseases; Interferons; Interferon-alpha; Antineoplastic Agents; Antiviral Agents; Anti-Infective Agents; Immunologic Factors; Physiological Effects of Drugs