ESP Study: A Study to Assess the Effect of Adding Fuzeon (Enfuvirtide) to an Antiretroviral Regimen in Fuzeon-Naive Patients With Sustained HIV Viral Suppression.

NCT00461266 | Withdrawn Phase 4

• 1 other identifier: ML19355
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 7

Brief Summary

This 2 arm study will assess the immunological benefits of adding Fuzeon to an antiretroviral regimen in HIV-infected, Fuzeon-naive patients with a CD4 cell count \<250 cells/mm3 and an HIV RNA viral load \<400 copies/mL. Eligible patients will be randomized to receive Fuzeon 90mg bid sc in addition to their current antiretroviral therapy, or to continue their current antiretroviral therapy alone. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Conditions

HIV Infections

Keywords

Treatment Experienced

Outcome Measures

Primary Outcomes (1)

• Mean change in CD4 cell count from baseline

  Week 24

Secondary Outcomes (3)

• Change in HIV RNA from baseline

  Week 24

• Change in HIV RNA and CD4 cell count

  Weeks 24-48

• Correlation between CD4 count and HIV RNA; OIs; QoL; ADEs; SAEs.

  Throughout study

Study Arms (2)

1

EXPERIMENTAL

Drug: enfuvirtide [Fuzeon]; Drug: Antiretroviral therapy

2

ACTIVE COMPARATOR

Drug: Antiretroviral therapy

Interventions

enfuvirtide [Fuzeon] DRUG

90mg sc bid

1

Antiretroviral therapy DRUG

As prescribed

1; 2

Eligibility Criteria

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

You may qualify if:

• adult patients, \>=18 years of age;
• documented chronic HIV infection;
• currently receiving a stable antiretroviral regimen;
• CD4 cell count \<250 cells/mm3;
• HIV RNA viral load \<400 copies/mL for \>12 months.

You may not qualify if:

• prior exposure to Fuzeon;
• prior non-adherence to antiretroviral treatment regimens;
• active opportunistic infection;
• currently taking, or anticipated to take during the study, any immunomodulator.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (7)

Unknown Facility

Carlton, Australia

Location

Unknown Facility

Darlinghurst, Australia

Location

Unknown Facility

Melbourne, Australia

Location

Unknown Facility

Miami, Australia

Location

Unknown Facility

Perth, Australia

Location

Unknown Facility

South Yarra, Australia

Location

Unknown Facility

Sydney, Australia

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Enfuvirtide; Antiretroviral Therapy, Highly Active

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

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; Drug Therapy, Combination; Drug Therapy; Therapeutics

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2007
• First Posted: April 17, 2007
• Study Start: April 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: August 24, 2016

Record last verified: 2016-08

Locations

AU (7)