DRUG
Enfuvirtide-intensified HAART
90 mg tablet taken orally twice daily
Status
Unknown
Phase
Not applicable
Enrollment
20
Locations
1
Results
Not posted
Publications
0
Study 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.
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.
Interventions
DRUG
90 mg tablet taken orally twice daily
Timeline
First posted
Feb 7, 2005
Study start
Mar 2003
Primary completion
Dec 2005
Study completion
Mar 2009
Results posted
Not reported
Registry updated
Sep 17, 2008
Outcomes
HIV viral load
Time frame · Throughout study
Frequency of HIV-specific T cells
Time frame · Thoughout study
Eligibility
Inclusion Criteria: * HIV viral load of more than 1000 copies/ml * On stable antiretroviral therapy * Have multidrug resistance Exclusion Criteria: * Require immunomodulatory drugs
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
San Francisco General Hospital
San Francisco, California, United States
Publications
No PMID-linked publications were present in this registry snapshot.
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