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View Clinical Trial (Medical Research Study)
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Impact of an HPV Vaccine in HIV-Infected Young Women - NCT00710593-33101 (Clinical Trial 230092)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy230092.aspx
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Miami |
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State:
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FL |
| Zip Code: |
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33101 |
| Conditions: |
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HIV Infection |
| Purpose: |
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The purpose of this study is to evaluate the immunogenicity, safety, tolerability, and
behavioral impact of an HPV-6, -11, -16, -18 vaccine in HIV-infected young women.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- Young women age 16 years and 0 days to 23 years and 364 days
- HIV-infection after the age of 9 years as documented by a positive result on any of
the following licensed tests: any antibody test confirmed by Western blot, HIV-1
culture, HIV-1 DNA PCR, or plasma HIV-1 RNA > 1,000 copies/ml
- HIV treatment history that falls in one of the following categories:
Group A: ART naïve or if ART-exposed, has not received HAART for at least the six months
prior to study entry Group B: Has been receiving HAART for at least six months at the time
of study entry, with two HIV-1 RNA plasma viral loads < 400 copies/ml on two previous
clinical visits within the 6 months prior to study entry
- Willingness to avoid pregnancy from study entry through the Week 28 visit for
subjects of child-bearing potential, i.e., use of at least one barrier or hormonal
method; e.g., condoms, Depo-Provera, oral contraceptive pills, etc. Subjects on ARV
medications must use a barrier contraceptive method because ARV medications can make
hormonal birth control less effective.
- Anticipated ability and willingness to complete all study vaccines and evaluations
- Ability and willingness to participate in the study by providing written informed
consent
Exclusion Criteria:
- History of any prior vaccination with an HPV vaccine
- Active anogenital warts within three months prior to study entry) or history of CIN
2/3 (ever, must be documented by colposcopy)
- Previous allergic reaction to any constituents of the HPV vaccine
- Pregnancy
- Active substance use or dependence that, in the opinion of the site personnel, would
interfere with adherence to the study
- Active opportunistic infection or current treatment for known or suspected active
serious bacterial infection at the time of study entry
- Presence of any known > Grade 3 clinical or laboratory toxicity at the time of study
entry (per the ATN Toxicity Tables, see ATN MOGO) with the exception of isolated
Grade 3 serum total hyperbilirubinemia that is considered due to atazanavir (see
Section 9.6 for definition of isolated total hyperbilirubinemia).
- Receipt of any routine vaccine within four weeks prior to study entry
- Receipt of any immune globulin or plasma product within six months prior study entry
- Receipt of any blood product or transfusion, other than immune globulin or plasma as
noted above, within four weeks prior to study entry
- Receipt of any restricted medication listed in Section 5.3.2 within the four weeks
preceding study entry
- Receipt of any other disallowed medication listed in Section 5.3.3 within the three
months preceding study entry
- Thrombocytopenia or coagulation disorder that would contraindicate intramuscular
injection
- Anticipation of long-term systemic corticosteroid therapy (more than 10 mg/day of
prednisone or equivalent for > 2 consecutive weeks)
- Receipt of corticosteroid therapy at the above dose and duration within 3 months
preceding study entry. Use of non-steroidal anti-inflammatory agents and inhaled or
topical corticosteroids are not exclusion criteria
- Known or suspected disease of the immune system (other than HIV), i.e., malignancy,
current or prior treatment for malignancy
- If other serious, acute or chronic medical or surgical conditions or
contraindications are present during screening, the Protocol Team must be consulted
to determine whether enrollment may interfere with the evaluation of the protocol
objectives and for permission to proceed with the enrollment |
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| Study is available at: |
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University of Miami School of Medicine
Miami, FL 33101
United States
Primary Contact:
Donna Maturo, ARNP
Email: dmaturo@med.miami.edu
Phone: 305-243-3442
Secondary Contact:
Nancy Liu, M.P.H.
Email: nancyliu@westat.com
Phone: (718) 980-3937 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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