RAL-eve Study: Raltegravir Substitution Study
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00523237 |
Recruitment Status
:
Completed
First Posted
: August 31, 2007
Results First Posted
: October 28, 2011
Last Update Posted
: November 2, 2011
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 |
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 |

-
Drug: Raltegravir
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
United States, California | |
Stanford University School of Medicine | |
Stanford, California, United States, 94305 |
Principal Investigator: | Andrew R Zolopa | Stanford University |
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 |