Philip Grant
Raltegravir substitution for enfuvirtide in patients suffering from injection site reactions (ISRs): The Raleve pilot study
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
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
Recruiting Status:
No longer recruitingStanford Recruiting Status:
No longer recruitingCondition(s):
Intervention(s):
- Drug: Raltegravir (MK-0518)
Phase:
N/AEligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key 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 (for example, <50 copies/mL on Roche Amplicor HIV-1 Monitor Test or viral load<75 copies/mL on a bDNA assay), for a period of at least 6 months before study entry, verified by at least two measurements separated from each other by at least 60 days. The first measurement must be performed at least 3 months prior to study entry, and the second measurement must be performed within 60 days prior to study entry (the measurement obtained at the time of screening may be used to fulfill this criterion). Patients with a viral load > 50 copies, but less than 200 copies within the 6 month prior to entry will be eligible as long as the viral loads prior to and after the dectectable viral load are < 50 copies.
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 dectable 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 (women who have not been post-menopausal for at least 24 consecutive months, i.e., who have had menses within the preceding 24 months, or women who have not undergone surgical sterilization, specifically hysterectomy, or bilateral oophorectomy and/or tubal ligation), will need a negative serum or urine pregnancy test within 48 hours prior to entry.
NOTE: Acceptable documentation of hysterectomy and bilateral oophorectomy, tubal ligation, tubal micro-inserts, vasectomy, and menopause is subject-reported history.
10 All subjects must agree not to participate in the conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization), and if participating in sexual activity that could lead to pregnancy, the subject/ partner must use at least two reliable methods of contraception, (condoms, with or without a spermicidal agent; a diaphragm or cervical cap with spermicide; an IUD; or hormonal based contraception), while receiving study treatment and for 6 weeks after stopping study treatment.
11 Men and women age >18 years.
12 Ability and willingness of subject to provide informed consent.
Key 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.
Additional Study Details
Official Title:
Raltegravir substitution for enfuvirtide in patients suffering from injection site reactions (ISRs): The Raleve pilot studyAnticipated start date:
10/22/2007Lead Sponsor:
Stanford UniversityInvestigator(s):
- Andrew R Zolopa
- Michael J. Harbour
- Philip Grant
- Nancy Shulman
Study Type:
InterventionalPurpose:
TreatmentAllocation:
Non-randomizedMasking:
OpenControl:
noneAssignment:
Single GroupEndpoints:
Safety/EfficacyPrimary Outcomes:
- To quantify the percentafe of patients who maintain a viral load < 50 copies/ml after being switched from enfuvirtide to raltegravir
Secondary Outcomes:
- To quatify the changes in viral load (from pre to post switch) using a super-sensitive viral load assay (eg < 5 copies/ml)
- To quantify the change in CD4 count associated with the switch from enfuvirtide to raltegravir
- To assess the tolerability and safety of raltegravir
- To evaluate change in quality of life associated with the change in enfuvirtide to raltegravir
Total Number to be Enrolled:
15Total Number to be Enrolled at Stanford:
15More Information
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
2/18/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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