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RAL-eve Study: Raltegravir Substitution Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00523237
First received: August 29, 2007
Last updated: October 31, 2011
Last verified: October 2011

August 29, 2007
October 31, 2011
October 2007
March 2009   (final data collection date for primary outcome measure)
The Percentage of Patients Who Maintain a Viral Load < 50 Copies/ml After Being Switched From Enfuvirtide to Raltegravir [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
evaluate the percent of patients with viral load of <50 copies at week 24 of study after being switched from enfuvirtide to raltegravir
To quantify the percentage of patients who maintain a viral load< 50 copies after being switched from enfuvirtide to raltegravir [ Time Frame: 24 weeks ]
Complete list of historical versions of study NCT00523237 on ClinicalTrials.gov Archive Site
Not Provided
  • To quantify teh changes in viral load (from pre to post switch) using a supersensitive viral load assay (eg <5 copies/ml) [ Time Frame: 24 weeks ]
  • To quantify a change in CD4 count associated with the switch from enfuvirtide to raltegravir [ Time Frame: 24 weeks ]
  • To assess tolerability and safety of raltergravir [ Time Frame: 24 weeks ]
  • To evaluate change in quality of life associated with the change in enfuvirtide to raltegravir [ Time Frame: 24 weeks ]
Not Provided
Not Provided
 
RAL-eve Study: Raltegravir Substitution Study
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

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
Drug: Raltegravir
400 mg Twice daily for 24 weeks
Other Name: Isentress
Not Provided
Grant PM, Palmer S, Bendavid E, Talbot A, Slamowitz DC, Cain P, Kobayashi SS, Balamane M, Zolopa AR. Switch from enfuvirtide to raltegravir in virologically suppressed HIV-1 infected patients: effects on level of residual viremia and quality of life. J Clin Virol. 2009 Dec;46(4):305-8. Epub 2009 Oct 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
December 2010
March 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00523237
RAL-eve study
No
Stanford University
Stanford University
Not Provided
Principal Investigator: Andrew R Zolopa Stanford University
Stanford University
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP