Treatment Intensification for HIV Infected Patients With Multi-Drug Resistant Virus
Primary Purpose
HIV Infections
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enfuvirtide-intensified HAART
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV, Drug Resistance, Viral Fitness, HIV Specific Immunity, T Cell Activation, Drug Resistant Viremia, Treatment Experienced
Eligibility Criteria
Inclusion Criteria: HIV viral load of more than 1000 copies/ml On stable antiretroviral therapy Have multidrug resistance Exclusion Criteria: Require immunomodulatory drugs
Sites / Locations
- San Francisco General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Participants will receive enfuvirtide for 6 months
Outcomes
Primary Outcome Measures
HIV viral load
Secondary Outcome Measures
Frequency of HIV-specific T cells
Full Information
NCT ID
NCT00102934
First Posted
February 4, 2005
Last Updated
September 16, 2008
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
1. Study Identification
Unique Protocol Identification Number
NCT00102934
Brief Title
Treatment Intensification for HIV Infected Patients With Multi-Drug Resistant Virus
Official Title
Treatment Intensification in HIV-1 Patients With Multi-Drug Resistant Virus
Study Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Unknown status
Study Start Date
March 2003 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
March 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
4. Oversight
5. Study Description
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.
Detailed Description
While an HIV infected patient is taking highly active antiretroviral therapy (HAART), drug-resistant HIV may emerge; however, it has been observed that HIV viral loads while on HAART are usually lower than baseline levels. Expansion of the T cell population during early HAART may explain this phenomenon. It is hoped that a short but aggressive HAART regimen to treatment-experienced patients who have drug-resistant virus will produce immune cells that will better control drug-resistant virus. This study will determine if a 6-month HAART regimen intensified by enfuvirtide (T-20) is effective in eliciting a stronger immune response against drug-resistant virus.
This study will last 48 weeks. All participants will receive T-20 as part of a HAART intensification regimen; HAART other than T-20 will not be provided by the study. There will be 17 study visits. Prior to beginning treatment intensification, participants will have weekly study visits for three weeks. Once treatment intensification has started, participants will be followed weekly for four weeks, then weekly for four weeks after treatment intensification, then monthly thereafter. Blood collection will occur at each visit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, Drug Resistance, Viral Fitness, HIV Specific Immunity, T Cell Activation, Drug Resistant Viremia, Treatment Experienced
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive enfuvirtide for 6 months
Intervention Type
Drug
Intervention Name(s)
Enfuvirtide-intensified HAART
Other Intervention Name(s)
T-20, Fuzeon
Intervention Description
90 mg tablet taken orally twice daily
Primary Outcome Measure Information:
Title
HIV viral load
Time Frame
Throughout study
Secondary Outcome Measure Information:
Title
Frequency of HIV-specific T cells
Time Frame
Thoughout study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
HIV viral load of more than 1000 copies/ml
On stable antiretroviral therapy
Have multidrug resistance
Exclusion Criteria:
Require immunomodulatory drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven G. Deeks, MD
Organizational Affiliation
Department of Medicine, University of California - San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Francisco General Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Treatment Intensification for HIV Infected Patients With Multi-Drug Resistant Virus
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