Pilot Study Evaluating Interruption of Enfuvirtide (Fuzeon, T20) in Patients With Enfuvirtide Resistance - Full Text View

Sponsors and Collaborators:	University of California, San Francisco The University-Wide AIDS Research program
Information provided by:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00187551

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
HIV Infections	Drug: Interruption of enfuvirtide

MedlinePlus related topics: AIDS

Drug Information available for: Enfuvirtide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Partial Treatment Interruptions in HIV-1 Patients With Multi-Drug Resistant Virus

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

Primary Outcome Measures:

CD4
viral load
resistance assays at weeks 4, 12, 24, 48 after enfuvirtide interruption

Estimated Enrollment:	50
Study Start Date:	May 2000

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00187551

Locations

United States, California
San Francisco General Hospital
San Francisco, California, United States, 94110

Sponsors and Collaborators

University of California, San Francisco

The University-Wide AIDS Research program

Investigators

Principal Investigator:

Steven G Deeks, M.D.

University of California, San Francisco

More Information

Study ID Numbers:	H8211-18804-05
Study First Received:	September 13, 2005
Last Updated:	June 16, 2006
ClinicalTrials.gov Identifier:	NCT00187551
Health Authority:	United States: Institutional Review Board

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

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Retroviridae Infections
Enfuvirtide
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
Slow Virus Diseases
Anti-HIV Agents
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Infection

Antiviral Agents
Pharmacologic Actions
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
HIV Fusion Inhibitors

ClinicalTrials.gov processed this record on January 15, 2009