Andrew Zolopa
A5262: A Pilot Efficacy and Safety Trial of Raltegravir Plus Darunavir/Ritonavir for Treatment-Naive HIV-1-Infected Subjects
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
HIV-1-infected, antiretroviral (ARV)-naive subjects will receive raltegravir (RAL) plus darunavir (DRV)/ritonavir (RTV) in this single-arm, open-label, 52-week pilot study. The primary endpoint is the cumulative proportion of subjects with virologic failure at or prior to week 24. All subjects will undergo routine monitoring including plasma HIV-1 RNA, CD4/CD8, hematology, chemistry, urinalysis, and fasting lipid profiles. Adherence to study medications will be assessed by self-report.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: Raltegravir
- Drug: Darunavir
- Drug: Ritonavir
Phase:
Phase 2/Phase 3Eligibility
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, HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA any time prior to study entry.
2 Plasma HIV-1 RNA >5000 copies/mL obtained within 90 days prior to study entry.
3 HIV genotype (for RT and protease) performed any time prior to study entry. Testing will be performed at screening if not available in the subject?s medical record or done as part of routine care.
NOTE: Subjects with single or combination NNRTI or NRTI RAM(s) at screening are permitted.
4 ARV drug-naive (defined as no previous ARV treatment at any time prior to study entry) or <14 days of non-PI and non-integrase inhibitor therapy.
5 Negative result from a hepatitis B surface antigen test performed within 90 days prior to study entry.
6 Laboratory values obtained within 45 days prior to study entry:
? Absolute neutrophil count (ANC) >750/mm3
? Hemoglobin >10 g/dL
? Platelets >50,000/mm3
? AST (SGOT), ALT (SGPT), and alkaline phosphatase <5 x upper limit of normal (ULN)
? Total bilirubin <2.5 x ULN
7 Negative serum or urine pregnancy test at screening and within 48 hours prior to study entry for women with reproductive potential (defined as women who have not been postmenopausal for at least 24 consecutive months, i.e., who have had menses within the preceding 24 months, or have not undergone surgical sterilization [e.g., hysterectomy, bilateral oophorectomy, or salpingectomy]). The urine test must have a sensitivity of <50 mIU/mL.
8 If participating in sexual activity that could lead to pregnancy, subjects with reproductive potential must use one form of contraceptive as listed below while receiving protocol-specified medications and for 60 days after stopping the medications. At least one of the following methods MUST be used appropriately:
? Condoms (male or female) with or without a spermicidal agent. Condoms are recommended because their appropriate use is the only contraception method effective for preventing HIV transmission.
? Diaphragm or cervical cap with spermicide
? IUD (intrauterine device)
? Hormone-based contraceptive. Some medications alter the metabolism of hormone-based contraceptives. This interaction may make hormone-based contraceptives less effective. Therefore, an alternative or an additional contraception method may be required.
Subjects who are not of reproductive potential or are sexually abstinent are eligible without requiring the use of contraceptives.
Subject-reported history is acceptable documentation of sterilization, other contraception methods, menopause, and reproductive potential.
9 Men and women age >18 years.
10 Ability and willingness of subject or legal guardian/representative to provide informed consent.
Key Exclusion Criteria:
1 Serious illness requiring systemic treatment and/or hospitalization until candidate either completes therapy or is clinically stable on therapy, in the opinion of the site investigator, for at least 7 days prior to study entry.
NOTE: Oral candidiasis, vaginal candidiasis, mucocutaneous herpes simplex, and other minor illnesses (as judged by the site investigator) have no restriction.
2 Screening HIV genotype obtained any time prior to study entry with more than one DRV RAM (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, I84V, and L89V) or L76V alone.
3 Known major integrase inhibitor RAM(s) which include N155H, Q148H/R/K, Y143C/R, and G140S.
NOTE: Routine screening for integrase inhibitor resistance will not be performed.
4 Severe renal insufficiency requiring hemodialysis or peritoneal dialysis.
5 Treatment within 30 days prior to study entry with immune modulators such as systemic steroids, interleukins, interferons, granulocyte colony-stimulating factor (G-CSF), erythropoietin, or any investigational therapy.
NOTE: Subjects receiving stable physiologic glucocorticoid doses (defined as prednisone <10 mg/day [or equivalent] as a stable or tapering dose) are permitted. Subjects receiving corticosteroids for acute therapy for PCP or asthma exacerbation, or receiving a short course (defined as <2 weeks of pharmacologic glucocorticoid therapy) are permitted.
6 Breast-feeding
7 Requirements for any current medications that are prohibited with any study medications.
8 Known allergy/sensitivity to study drugs or their formulations. A history of sulfa allergy is not an exclusion.
9 Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
Additional Study Details
Official Title:
A5262: A Pilot Efficacy and Safety Trial of Raltegravir Plus Darunavir/Ritonavir for Treatment-Naive HIV-1-Infected SubjectsAnticipated start date:
3/2/2009Lead Sponsor:
AIDS Clinical Trials GroupInvestigator(s):
- Andrew R Zolopa
- Michael J. Harbour
Study Type:
InterventionalPurpose:
TreatmentAllocation:
Non-randomizedMasking:
OpenControl:
noneAssignment:
Single GroupEndpoints:
Safety/EfficacyPrimary Outcomes:
- To estimate the cumulative proportion of ART-naive subjects experiencing virologic failure at or prior to week 24 after initiating RAL plus DRV/RTV.
Secondary Outcomes:
- To evaluate the safety and tolerability of RAL plus DRV/RTV.
- To evaluate virologic responses over 52 weeks of study treatment.
- To describe early virologic response to the combination of RAL plus DRV/RTV
Total Number to be Enrolled:
111Total Number to be Enrolled at Stanford:
5More 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:
4/27/2009PLEASE 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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