Treatment Intensification for HIV Infected Patients With Multi-Drug Resistant Virus

Study Overview
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Brief Summary
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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
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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.

Official Title
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Treatment Intensification in HIV-1 Patients With Multi-Drug Resistant Virus

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Enfuvirtide-intensified HAART


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV viral load of more than 1000 copies/ml On stable antiretroviral therapy Have multidrug resistance Exclusion Criteria: Require immunomodulatory drugs

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Participants will receive enfuvirtide for 6 months | Drug: Enfuvirtide-intensified HAART<br>* 90 mg tablet taken orally twice daily<br>* Other names: Fuzeon;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV viral load |  | Throughout study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of HIV-specific T cells |  | Thoughout study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Drug Resistance, Viral Fitness, HIV Specific Immunity, T Cell Activation, Drug Resistant Viremia, Treatment Experienced