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Pilot Study Evaluating Interruption of Enfuvirtide (Fuzeon, T20) in Patients With Enfuvirtide Resistance

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00187551
First Posted: September 16, 2005
Last Update Posted: February 10, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Universitywide AIDS Research Program
Information provided by:
University of California, San Francisco
  Purpose
The goal of this study is to examine whether enfuvirtide (T20, Fuzeon) has continued anti-HIV activity in patients experiencing an incomplete virologic response to an enfuvirtide-based regimen.

Condition Intervention Phase
HIV Infections Other: Interruption of enfuvirtide Other: enfuvirtide interrupton Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Partial Treatment Interruptions in HIV-1 Patients With Multi-Drug Resistant Virus

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • CD4 [ Time Frame: week 24 ]

Enrollment: 25
Study Start Date: May 2000
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: interruption of enfuvirtide
enfuvirtide interruption
Other: Interruption of enfuvirtide
treatment interruption
Other: enfuvirtide interrupton
enfuvitide will be interrupted in patients harboring resistant virus

Detailed Description:

Some patients do not achieve an undetectable HIV viral load with an enfuvirtide (T20, Fuzeon) based antiretroviral regimen. As a consequence, enfuvirtide resistant virus can emerge. It is not yet known if enfuvirtide has continued virologic or immunologic benefit after the drug-resistant variant emerges. Interrupting enfuvirtide may reduce the accumulation of enfuvirtide mutations and may allow for a potent response of enfuvirtide with future regimens.

Subjects must have evidence of viral replication (HIV RNA > 1,000 copies/ml on two consecutive measurements) while on a stable antiretroviral regimen containing enfuvirtide. Patients will then interrupt enfuvirtide while continuing all other antiretroviral agents. Subjects will be seen weekly for four weeks, every two weeks for an additional 8 weeks, and then every four weeks through week 48.

Plasma HIV RNA levels and CD4+/CD8+ T cell counts will be measured in real time at each visit, and provided to the referring primary care physician. Subjects will be allowed to resume enfuvirtide at any time during the course of this study. Subjects will be encouraged to resume enfuvirtide (with or without modifying the background regimen) if plasma HIV RNA levels increase by > 0.5 log on two consecutive occasions. Subjects are seen every four weeks for 24 weeks after enfuvirtide is resumed.

Plasma will be collected at those visits for HIV RNA and stored for retrospective genotype/phenotype evaluation.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Currently receiving continuous enfuvirtide-based antiretroviral therapy.
  • Documentation of recent plasma HIV RNA level greater than the lower limit of detection (measured within the preceding 4 weeks)
  • Screening plasma HIV-1 RNA level > 1000 copies/mL.
  • Negative serum pregnancy test (for women of childbearing potential) documented within the 14-day period prior to study entry.
  • Subjects must be able to give written informed consent and agree to abide by the requirements of the study.

Exclusion Criteria:

  • Unstable HIV disease status such that interrupting any antiretroviral therapy poses significant short-term risk for disease progression (as determined by study investigators and referring primary care provider).
  • Female subjects who are pregnant, breastfeeding, or who plan to become pregnant during the study.
  • Active hepatitis C infection requiring treatment with an interferon-based regimen.
  • Evidence of active, untreated opportunistic infections or unexplained temperature which is > 38.5°C for seven consecutive days, within 30 days prior to the first screening visit.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00187551


Locations
United States, California
San Francisco General Hospital
San Francisco, California, United States, 94110
Sponsors and Collaborators
University of California, San Francisco
Universitywide AIDS Research Program
Investigators
Principal Investigator: Steven G Deeks, M.D. University of California, San Francisco
  More Information

Responsible Party: Steven Deeks, UCSF
ClinicalTrials.gov Identifier: NCT00187551     History of Changes
Other Study ID Numbers: H8211-18804-05
First Submitted: September 13, 2005
First Posted: September 16, 2005
Last Update Posted: February 10, 2011
Last Verified: June 2006

Keywords provided by University of California, San Francisco:
enfuvirtide
T20
Fuzeon
Treatment
Interruption
Resistance
HIV Drug Resistance
Antiretroviral Agents
Salvage Therapy
Drug Resistance, Multiple
Human Immunodeficiency virus

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
Enfuvirtide
HIV Fusion Inhibitors
Viral Fusion Protein Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents


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