Intensification With Enfuvirtide in Naive HIV-infected Patients (ANRS130)

NCT00302822 | Completed Phase 3 DMC

• 1 other identifier: 2005-004722-12
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

Brief Summary

HIV infection is diagnosed late in a substantial proportion of patients having an increased risk of clinical progression (AIDS, new AIDS-defining event or death). The currently recommended antiretroviral therapy has suboptimal activity in this setting and potent quadruple-drug therapy has not been sufficiently evaluated. Enfuvirtide may be an appropriate candidate as the fourth antiretroviral agent, regarding its activity, its parenteral administration avoiding gastrointestinal symptoms that often lead to interruption of treatment, the lack of pharmacokinetic interactions and the absence of systemic toxicity. The aim of this study is to investigate, in a comparative intensification trial, the immunological benefit of adding enfuvirtide for 6 months to a conventional antiretroviral therapy in HIV-1 infected and severely immunosuppressed patients, naïve of any antiretroviral treatment. We postulate that addition of enfuvirtide to a first-line antiretroviral therapy consisting in emtricitabine/tenofovir combined with either efavirenz or lopinavir/r may improve immunological restoration, measured as the proportion of patients with more than 200 CD4 cells per mm3 after 24 weeks of antiretroviral therapy.

Conditions

HIV Infections; AIDS

Keywords

HIV infections; Fuzeon; Truvada; AIDS; Treatment Naive

Outcome Measures

Primary Outcomes (1)

• Immunological success defined as a CD4 cell count above 200 cells per mm3 after 24 weeks of initial antiretroviral treatment

  24 weeks

Secondary Outcomes (1)

• Virological response, clinical progression, tolerance,toxicity, quality of life under therapy, adherence and resistance mutations emerging in case of virological failure.

  from 0 to 48 weeks

Study Arms (2)

Intensification

EXPERIMENTAL

lopinavir or efavirenz and emtricitabine/tenofovir and intensification with enfuvirtide (week 0 to 24)

Drug: enfuvirtide; Drug: emtricitabine/tenofovir; Drug: lopinavir or efavirenz

Standard

ACTIVE COMPARATOR

lopinavir or efavirenz and emtricitabine/tenofovir

Drug: emtricitabine/tenofovir; Drug: lopinavir or efavirenz

Interventions

enfuvirtide DRUG

from week 0 to 24

Also known as: Fuzeon

Intensification

emtricitabine/tenofovir DRUG

1 pill/day

Also known as: Truvada

Intensification; Standard

lopinavir or efavirenz DRUG

investigator choice

Also known as: Kaletra, Sustiva

Intensification; Standard

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Antiretroviral naïve HIV-1 infected patients
• CD4 cell count below 100 per mm3, or CD4 cell count below 200/mm3 and past history or presence of B or C(AIDS defining)event
• Signed informed consent

You may not qualify if:

• Pregnancy; breast feeding
• Coinfection with HIV-2 or infection with HIV-1 subtype O
• Antiretroviral pretreated patients
• Neoplasia disease currently treated with chemotherapy or radiotherapy
• Severe liver failure
• Treatment with cytokines or HIV vaccine trial
• One or more of the following biological abnormalities: hemoglobin below 10 g/dl, Neutrophils below 750 per mm3, thrombocytopenia below 50000 per mm3, creatinine clearance below 60 ml per min, Liver Function Tests over 3 Upper Limit of Normal

Sponsors & Collaborators

• French National Agency for Research on AIDS and Viral Hepatitis: lead
• Hoffmann-La Roche: collaborator
• Gilead Sciences: collaborator

Study Sites (1)

Service des Maladies Infectieuses A Hôpital Bichat-Claude Bernard

Paris, 75018, France

Location

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

Enfuvirtide; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Lopinavir; efavirenz; lopinavir-ritonavir drug combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; HIV Envelope Protein gp41; Viral Fusion Proteins; Membrane Fusion Proteins; Membrane Proteins; Proteins; HIV Antigens; Antigens, Viral; Viral Proteins; env Gene Products, Human Immunodeficiency Virus; Gene Products, env; Retroviridae Proteins; Human Immunodeficiency Virus Proteins; Viral Envelope Proteins; Viral Structural Proteins; Antigens; Biological Factors; Tenofovir; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations; Pyrimidinones

Study Officials

• Veronique Joly, MD

  Hopital Bichat Claude Bernard Paris France

  PRINCIPAL INVESTIGATOR

• Geneviève Chêne, MD PHD

  INSERM U897 Bordeaux France

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2006
• First Posted: March 15, 2006
• Study Start: April 1, 2006
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: July 10, 2013

Record last verified: 2013-07

Locations

FR (1)