Back to results

RAL-eve Study: Raltegravir Substitution Study

Primary Purpose

HIV Infections

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Raltegravir

About this trial

This is an interventional treatment trial for HIV Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Stanford University School of Medicine

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00523237

First Posted

August 29, 2007

Last Updated

October 31, 2011

Sponsor

Stanford University

1. Study Identification

Unique Protocol Identification Number

NCT00523237

Brief Title

RAL-eve Study: Raltegravir Substitution Study

Official Title

Raltegravir Substitution for Enfuvirtide in Patients Suffering From Injection Site Reactions (ISRs): The Raleve Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

October 2011

Overall Recruitment Status

Completed

Study Start Date

October 2007 (undefined)

Primary Completion Date

March 2009 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Stanford University

4. Oversight

Data Monitoring Committee

5. Study Description

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Raltegravir

Other Intervention Name(s)

Isentress

Intervention Description

400 mg Twice daily for 24 weeks

Primary Outcome Measure Information:

Title

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

Description

evaluate the percent of patients with viral load of <50 copies at week 24 of study after being switched from enfuvirtide to raltegravir

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrew R Zolopa

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford University School of Medicine

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

19819183

Citation

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.

Results Reference

result

Learn more about this trial

RAL-eve Study: Raltegravir Substitution Study

We'll reach out to this number within 24 hrs