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

NCT ID: NCT00102934

Last Updated: 2008-09-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-03-31
• Study Completion Date: 2009-03-31

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.

Conditions

HIV Infections

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Participants will receive enfuvirtide for 6 months

Group Type: EXPERIMENTAL

Enfuvirtide-intensified HAART

Intervention Type: DRUG

90 mg tablet taken orally twice daily

Interventions

Enfuvirtide-intensified HAART

90 mg tablet taken orally twice daily

Intervention Type: DRUG

Other Intervention Names

T-20; Fuzeon

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Responsible Party

Department of Medicine, University of California - San Francisco

Principal Investigators

Steven G. Deeks, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Medicine, University of California - San Francisco

Locations

San Francisco General Hospital

San Francisco, California, United States

Countries

United States

Other Identifiers

Protocol 834

Identifier Type: -

Identifier Source: secondary_id

5R21AI055273-02

Identifier Type: NIH

Identifier Source: secondary_id

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5R21AI055273-02

Identifier Type: NIH

Identifier Source: org_study_id

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