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| Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00102934 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
HIV Infections |
Drug: Enfuvirtide-intensified HAART |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Treatment Intensification in HIV-1 Patients With Multi-Drug Resistant Virus |
| Enrollment: | 20 |
| Study Start Date: | March 2003 |
| Estimated Study Completion Date: | March 2009 |
| Primary Completion Date: | December 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| Responsible Party: | Department of Medicine, University of California - San Francisco ( Steven G. Geeks, MD ) |
| Study ID Numbers: | 5R21AI055273-02, Protocol 834, 5R21-AI055273-02 |
| Study First Received: | February 4, 2005 |
| Last Updated: | September 16, 2008 |
| ClinicalTrials.gov Identifier: | NCT00102934 History of Changes |
| Health Authority: | United States: Federal Government |
|
HIV Drug Resistance Viral Fitness HIV Specific Immunity |
T Cell Activation Drug Resistant Viremia Treatment Experienced |
|
Sexually Transmitted Diseases, Viral Anti-HIV Agents Acquired Immunodeficiency Syndrome Antiviral Agents Immunologic Deficiency Syndromes Enfuvirtide Virus Diseases |
Anti-Retroviral Agents HIV Infections Sexually Transmitted Diseases Viremia Retroviridae Infections HIV Fusion Inhibitors |
|
Anti-Infective Agents RNA Virus Infections Sexually Transmitted Diseases, Viral Anti-HIV Agents Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Acquired Immunodeficiency Syndrome Infection Antiviral Agents Pharmacologic Actions |
Immunologic Deficiency Syndromes Enfuvirtide Virus Diseases Anti-Retroviral Agents HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections HIV Fusion Inhibitors |
