RAL-eve Study: Raltegravir Substitution Study

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:

Drug: Raltegravir
400 mg Twice daily for 24 weeks
Other Name: Isentress

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

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.

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
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