RAL-eve Study: Raltegravir Substitution Study

NCT00523237 | Completed Results

• 1 other identifier: RAL-eve study
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

• The Percentage of Patients Who Maintain a Viral Load < 50 Copies/ml After Being Switched From Enfuvirtide to Raltegravir

  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

Interventions

Raltegravir DRUG

400 mg Twice daily for 24 weeks

Also known as: Isentress

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (1)

• 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. doi: 10.1016/j.jcv.2009.09.025. Epub 2009 Oct 12.

  PMID: 19819183 RESULT

MeSH Terms

Conditions

HIV Infections

Interventions

Raltegravir Potassium

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Philip Grant, MD
• Organization: Stanford University

pmgrant@stanford.edu

650-723-2804

Study Officials

• Andrew R Zolopa

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2007
• First Posted: August 31, 2007
• Study Start: October 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: December 1, 2010
• Last Updated: November 2, 2011
• Results First Posted: October 28, 2011

Record last verified: 2011-10

Locations

US (1)