Treatment Intensification for HIV Infected Patients With Multi-Drug Resistant Virus
Recruitment status was Active, not recruiting
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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: | 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 ]
| 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 |
|---|---|
|
Experimental: 1
Participants will receive enfuvirtide for 6 months
|
Drug: Enfuvirtide-intensified HAART
90 mg tablet taken orally twice daily
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- HIV viral load of more than 1000 copies/ml
- On stable antiretroviral therapy
- Have multidrug resistance
Exclusion Criteria:
- Require immunomodulatory drugs
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
Additional Information:
No publications provided
| Responsible Party: | Steven G. Geeks, MD, Department of Medicine, University of California - San Francisco |
| ClinicalTrials.gov Identifier: | NCT00102934 History of Changes |
| Other Study ID Numbers: | 5R21AI055273-02, Protocol 834, 5R21-AI055273-02 |
| Study First Received: | February 4, 2005 |
| Last Updated: | September 16, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
HIV Drug Resistance Viral Fitness HIV Specific Immunity |
T Cell Activation Drug Resistant Viremia Treatment Experienced |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Slow Virus Diseases Enfuvirtide HIV Fusion Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013