Treatment Intensification for HIV Infected Patients With Multi-Drug Resistant Virus
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|ClinicalTrials.gov Identifier: NCT00102934|
Recruitment Status : Unknown
Verified September 2008 by National Institute of Allergy and Infectious Diseases (NIAID).
Recruitment status was: Active, not recruiting
First Posted : February 7, 2005
Last Update Posted : September 17, 2008
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: Enfuvirtide-intensified HAART||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment Intensification in HIV-1 Patients With Multi-Drug Resistant Virus|
|Study Start Date :||March 2003|
|Actual Primary Completion Date :||December 2005|
|Estimated Study Completion Date :||March 2009|
Participants will receive enfuvirtide for 6 months
Drug: Enfuvirtide-intensified HAART
90 mg tablet taken orally twice daily
- HIV viral load [ Time Frame: Throughout study ]
- Frequency of HIV-specific T cells [ Time Frame: Thoughout study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00102934
|United States, California|
|San Francisco General Hospital|
|San Francisco, California, United States, 94110|
|Principal Investigator:||Steven G. Deeks, MD||Department of Medicine, University of California - San Francisco|