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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00102934
• Other study ID #: 5R21AI055273-02
• Secondary ID: Protocol 8345R21
• Status: Active, not recruiting
• Phase: N/A
• First received: February 4, 2005
• Last updated: September 16, 2008
• Start date: March 2003
• Est. completion date: March 2009

Study information

• Verified date: September 2008
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: March 2009
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Enfuvirtide-intensified HAART
90 mg tablet taken orally twice daily

Locations

Country	Name	City	State
United States	San Francisco General Hospital	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV viral load		Throughout study	No
Secondary	Frequency of HIV-specific T cells		Thoughout study	No

External Links

•   Click here for more information about enfuvirtide