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

NCT00187551 | Completed Phase 4

• 1 other identifier: H8211-18804-05
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV Infections

Keywords

enfuvirtide; T20; Fuzeon; Treatment; Interruption; Resistance; HIV Drug Resistance; Antiretroviral Agents; Salvage Therapy; Drug Resistance, Multiple; Human Immunodeficiency virus

Outcome Measures

Primary Outcomes (1)

• CD4

  week 24

Study Arms (1)

interruption of enfuvirtide

EXPERIMENTAL

enfuvirtide interruption

Other: Interruption of enfuvirtide; Other: enfuvirtide interrupton

Interventions

Interruption of enfuvirtide OTHER

treatment interruption

interruption of enfuvirtide

enfuvirtide interrupton OTHER

enfuvitide will be interrupted in patients harboring resistant virus

interruption of enfuvirtide

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Universitywide AIDS Research Program: collaborator

Study Sites (1)

San Francisco General Hospital

San Francisco, California, 94110, United States

Location

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

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

Study Officials

• Steven G Deeks, M.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: May 1, 2000
• Primary Completion: November 1, 2005
• Study Completion: November 1, 2005
• Last Updated: February 10, 2011

Record last verified: 2006-06

Locations

US (1)