ACTG 5240: Phase 2 study of HPV vaccine in HIV-1 Infected Females
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
HPV infection can be more severe and harder to treat in people infected with HIV. This study will see if HPV vaccine, when given in 3 seperate doses, is safe and tolerable in females infected with HIV.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Vaccine: GARDASIL
Phase:
Phase 2Eligibility
Ages Eligible for Study:
Any Age to Any AgeGenders Eligible for Study:
MaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
1. HIV-1 infection, documented by a rapid HIV test or any licensed ELISA, Western Blot, HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA viral load or a second antibody test by a method other than ELISA at any time prior to study entry.
2. CD4 cell count obtained within 45 days prior to study entry at any laboratory that has a CLIA certification or its equivalent. Stratum A: CD4 cell count > 350 cells/mm3. Stratum B: CD4 cell count > 200 to < 350 cells/mm3. Stratum c: CD4 cell count < 200 cells/mm3.
3. HIV RNA viral load levels obtained within 45 days prior to study entry by any laboratory that has CLIA certification or its equivalent. US sites must use the ultra-sensitive assay. Group 1 (A1, B1, C1): HIV-1 RNA viral load < 10,000 copies/ml. Group 2 (A2, B2, C2): HIV-1 RNA viral load > 10,000 copies/ml.
4. If receiving HAART, then must be on same HAART regimen for at least 12 weeks prior to study entry with no change within 30 days prior to study entry.
5. Study participants of reproductive potential[defined as females who have reasched menarche or females who have not been post menopausal for at least 24 consecutive months, i.e, who have had menses within the preceding 24 months or have not undergone surgical steilization (i.e, bilateral tubal ligation,. Essure or any non-incisional permanent birth control procedure, bilateral oophorectomy, or bilateral salpingectoney)] must have a negative serum or urine pregnancy test performed within 45 days and also 48 hours prior to study entry.
6. Karnofsky performance score > 70 on at least one occasion within 45 days prior to study entry.
7. Following labs within 45 days of study entry: Hemoglobin >8.0g/dl, Direct bilirubin <2.5 times upper limit of normal (UNL), Alanine aminotransferase, ALT (SPGT), and aspartate aminotranferase AST (SGOT), <3 times ULN, Platelet count > 100,000/mm3.
8. Femailes >13 to < 45 years of age.
9. Ability and willingness to give informed consent.
Key Exclusion Criteria:
1. Current (per cervical Pap test withing 60 days prior to study entry) or history of cervical cancer or CINII or III.
2. Current (per cervical Pap test witin 60 days prior to study entry) or history of VIN II or III.
3. Physician diagnosed genital warts withing 180 days prior to study entry.
4. Previous cervical dysplasia treatment including loop electrosurgical excision procedure (LEEP), cervical cryotherapy, cone biopsy, and cervisal laser vaporization.
5. Use of any systemic antineoplastic or immunomodulatory treatment, systemic corticosteroids, investigational vaccines, interleukins, interferons, growth factors, or intravenous immunoglobulin (IVIG) within 45 days prior to study entry.
6. Pregnancy or breast-feeding.
7. Known allergy/sensitivity or any hypersensitivity to yeast or conponents of study treatment or its formulation.
8. Active drug or alcohol abuse or dependence or other condition that, in the opinion of the site investigator, would interfere with adherence to study requirements..
9. Serious illness requiring systemic treatment and/or hospitalization within 45 days prior to study entry.
10. Total hysterectomy (Participants with a cervix are eligible).
11. Hemophilla
12. Currently on anticoagulation therapy other tan acetylsalicylic acid.
13. Prior vaccination with an HPV vaccine.
Additional Study Details
Official Title:
ACTG 5240: A Phae II Study to Evaluate the Immunogenicity and Safety of a Quadrivalent Hman Papillomavirus Vaccine in HIV-1 Infected FemalesAnticipated start date:
3/3/2008Lead Sponsor:
AIDS Clinial Trials NetworkInvestigator(s):
- Andrew R Zolopa
- Michael J. Harbour
Study Type:
InterventionalPurpose:
PreventionAllocation:
Non-randomizedMasking:
OpenControl:
noneAssignment:
ParallelEndpoints:
Safety/EfficacyPrimary Outcomes:
- To assess the safety and tolerablity of quadrivalent HPV Recombinant vaccine
Total Number to be Enrolled:
0Total Number to be Enrolled at Stanford:
0More Information
Secondary ID(s):
- A5240
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:
11/18/2009PLEASE 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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