Treatment Intensification for HIV Infected Patients With Multi-Drug Resistant Virus
Recruitment status was Active, not recruiting
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Treatment Intensification in HIV-1 Patients With Multi-Drug Resistant Virus|
- HIV viral load [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Frequency of HIV-specific T cells [ Time Frame: Thoughout study ] [ Designated as safety issue: No ]
|Study Start Date:||March 2003|
|Estimated Study Completion Date:||March 2009|
|Primary Completion Date:||December 2005 (Final data collection date for primary outcome measure)|
Participants will receive enfuvirtide for 6 months
Drug: Enfuvirtide-intensified HAART
90 mg tablet taken orally twice daily
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|