NCT00102934

Brief Summary

Drug resistance may develop in HIV infected patients who take anti-HIV drugs, but most patients do well if they continue taking them. The purpose of this study is to test the effectiveness of a short, intensified course of anti-HIV drugs for controlling HIV infection in adults who have virus resistant to multiple drugs.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable hiv-infections

Timeline
Completed

Started Mar 2003

Longer than P75 for not_applicable hiv-infections

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

February 4, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 7, 2005

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

September 17, 2008

Status Verified

September 1, 2008

Enrollment Period

2.8 years

First QC Date

February 4, 2005

Last Update Submit

September 16, 2008

Conditions

HIV Infections

Keywords

HIVDrug ResistanceViral FitnessHIV Specific ImmunityT Cell ActivationDrug Resistant ViremiaTreatment Experienced

Outcome Measures

Primary Outcomes (1)

  • HIV viral load

    Throughout study

Secondary Outcomes (1)

  • Frequency of HIV-specific T cells

    Thoughout study

Study Arms (1)

1

EXPERIMENTAL

Participants will receive enfuvirtide for 6 months

Drug: Enfuvirtide-intensified HAART

Interventions

Enfuvirtide-intensified HAARTDRUG

90 mg tablet taken orally twice daily

Also known as: T-20, Fuzeon
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV viral load of more than 1000 copies/ml
  • On stable antiretroviral therapy
  • Have multidrug resistance

You may not qualify if:

  • Require immunomodulatory drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Francisco General Hospital

San Francisco, California, 94110, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Enfuvirtide

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Peptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsHIV Envelope Protein gp41Viral Fusion ProteinsMembrane Fusion ProteinsMembrane ProteinsProteinsHIV AntigensAntigens, ViralViral Proteinsenv Gene Products, Human Immunodeficiency VirusGene Products, envRetroviridae ProteinsHuman Immunodeficiency Virus ProteinsViral Envelope ProteinsViral Structural ProteinsAntigensBiological Factors

Study Officials

  • Steven G. Deeks, MD

    Department of Medicine, University of California - San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

February 4, 2005

First Posted

February 7, 2005

Study Start

March 1, 2003

Primary Completion

December 1, 2005

Study Completion

March 1, 2009

Last Updated

September 17, 2008

Record last verified: 2008-09

Locations

US(1)