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RAL-eve Study: Raltegravir Substitution Study

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ClinicalTrials.gov Identifier: NCT00523237
Recruitment Status : Completed
First Posted : August 31, 2007
Results First Posted : October 28, 2011
Last Update Posted : November 2, 2011
Sponsor:
Information provided by (Responsible Party):
Stanford University

Study Description
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Brief Summary:

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

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Raltegravir Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Raltegravir Substitution for Enfuvirtide in Patients Suffering From Injection Site Reactions (ISRs): The Raleve Pilot Study
Study Start Date : October 2007
Actual Primary Completion Date : March 2009
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Intervention Details:
  • Drug: Raltegravir
    400 mg Twice daily for 24 weeks
    Other Name: Isentress

Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. HIV-1 infection, as documented by any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry.
  2. ART for at least 6 months prior to study entry with a regimen that includes enfuvirtide.
  3. Self-defined infusion site reaction to enfuvirtide (usually will be painful inflammatory nodules)
  4. No change in ART regimen for at least 3 months prior to study entry.
  5. CD4+ cell count >50/mm3 at screening (obtained within 60 days prior to study entry).
  6. Documentation of HIV-1 RNA below the limit of quantification of an ultrasensitive assay
  7. 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.

  8. 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.
  9. For females of reproductive potential will need a negative serum or urine pregnancy test within 48 hours prior to entry.
  10. Men and women age >18 years.
  11. Ability and willingness of subject to provide informed consent.

Exclusion Criteria:

  1. 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.
  2. Breast-feeding or pregnancy.
  3. An opportunistic infection within 60 days prior to entry.
  4. Known allergy/sensitivity or any hypersensitivity to components of study drug(s) or their formulation.
  5. Active drug or alcohol use or dependence that, in the opinion of the Protocol Director, would interfere with adherence to study requirements.
  6. Receipt of a non-HIV vaccination within 30 days prior to study entry or plan for receipt of vaccination during the study.
  7. Plan to change the background ART within 24 weeks after study entry.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00523237


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Andrew R Zolopa Stanford University
More Information
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Publications of Results:

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00523237     History of Changes
Obsolete Identifiers: NCT00627939
Other Study ID Numbers: RAL-eve study
First Posted: August 31, 2007    Key Record Dates
Results First Posted: October 28, 2011
Last Update Posted: November 2, 2011
Last Verified: October 2011

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
 Raltegravir Potassium
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
HIV Integrase Inhibitors
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action