- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00523237
RAL-eve Study: Raltegravir Substitution Study
October 31, 2011 updated by: Stanford University
Raltegravir Substitution for Enfuvirtide in Patients Suffering From Injection Site Reactions (ISRs): The Raleve Pilot Study
The purpose of this study is to:
- Provide raltegravir to subjects with HIV and an undetectable viral load who are experiencing injection site reactions (ISR) to Enfuvirtide,
- Monitor the safety and efficacy of raltegravir, and
- Assess the change in quality of life in patients who have switched from Enfuvirtide to raltegravir
Study Overview
Detailed Description
We enrolled virologically suppressed HIV-1 infected patients with injection site reactions for a switch from enfuvirtide to raltegravir.
At baseline, enfuvirtide was switched to raltegravir without additional changes to the antiretroviral regimen allowed.
Viral load, T-cells, and toxicity were evaluated at baseline, 2, 4, 12 and 24 weeks.
Adherence and injection site reactions were evaluated at baseline, 4, 12 and 24 weeks.
The single-copy assay was used to measure HIV RNA levels at screening, baseline and at 12 and 24 weeks.
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Stanford, California, United States, 94305
- Stanford University School of Medicine
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- HIV-1 infection, as documented by any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry.
- ART for at least 6 months prior to study entry with a regimen that includes enfuvirtide.
- Self-defined infusion site reaction to enfuvirtide (usually will be painful inflammatory nodules)
- No change in ART regimen for at least 3 months prior to study entry.
- CD4+ cell count >50/mm3 at screening (obtained within 60 days prior to study entry).
- Documentation of HIV-1 RNA below the limit of quantification of an ultrasensitive assay
- All HIV-1 RNA levels obtained within 6 months prior to study entry are below the limits of quantification on all tests, except as explained above in section 4.1.6 for a single detectable viral load of <50 copies but <200 copies in last 6 months.
Laboratory values obtained within 60 days prior to entry:
- Absolute neutrophil count (ANC) >750/mm3
- Hemoglobin >9.0 g/dL for female subjects and>10.0 g/dL for male subjects
- Platelet count >50,000/mm3
- Calculated creatinine clearance (CrCl) >30 mL/min, as estimated by the Cockcroft-Gault equation*
- AST (SGOT), ALT (SGPT), and alkaline phosphatase <5 x ULN
- Total bilirubin <2.5 x ULN. If the subject is taking an indinavir- or atazanavir-containing regimen at the time of screening, total bilirubin <5 x ULN is acceptable.
- For females of reproductive potential will need a negative serum or urine pregnancy test within 48 hours prior to entry.
- Men and women age >18 years.
- Ability and willingness of subject to provide informed consent.
Exclusion Criteria:
- Unstable clinical condition, such as unstable cardiac disease, or cancer requiring ongoing chemotherapy or radiation therapy, or other medical condition which, in the opinion of the investigator, would preclude a subject from safely undergoing study procedures.
- Breast-feeding or pregnancy.
- An opportunistic infection within 60 days prior to entry.
- Known allergy/sensitivity or any hypersensitivity to components of study drug(s) or their formulation.
- Active drug or alcohol use or dependence that, in the opinion of the Protocol Director, would interfere with adherence to study requirements.
- Receipt of a non-HIV vaccination within 30 days prior to study entry or plan for receipt of vaccination during the study.
- Plan to change the background ART within 24 weeks after study entry.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Percentage of Patients Who Maintain a Viral Load < 50 Copies/ml After Being Switched From Enfuvirtide to Raltegravir
Time Frame: 24 weeks
|
evaluate the percent of patients with viral load of <50 copies at week 24 of study after being switched from enfuvirtide to raltegravir
|
24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Andrew R Zolopa, Stanford University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2007
Primary Completion (Actual)
March 1, 2009
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
August 29, 2007
First Submitted That Met QC Criteria
August 30, 2007
First Posted (Estimate)
August 31, 2007
Study Record Updates
Last Update Posted (Estimate)
November 2, 2011
Last Update Submitted That Met QC Criteria
October 31, 2011
Last Verified
October 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- HIV Integrase Inhibitors
- Integrase Inhibitors
- Raltegravir Potassium
Other Study ID Numbers
- RAL-eve study
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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