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View Clinical Trial (Medical Research Study)
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Safety of and Immune Response to the Human Papillomavirus (HPV) Vaccine in HIV-Infected Women - NCT00604175-90033B (Clinical Trial 340503)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy340503.aspx
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| City: |
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Los Angeles |
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State:
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CA |
| Zip Code: |
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90033 |
| Conditions: |
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HIV Infections - Sexually Transmitted Diseases |
| Purpose: |
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Human papillomavirus (HPV) is the most common sexually transmitted disease in the world. HPV
infection can cause genital warts and certain cervical problems, including cervical cancer.
HPV infection may be more severe and harder to treat in HIV-infected people. The purpose of
this study is to determine whether the quadrivalent HPV vaccine is safe, tolerable, and
effective in producing antibodies to HPV in HIV-infected women.
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| Study summary: |
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HPV is a DNA virus that affects both men and women. Approximately 90 types of HPV have been
identified, 30 of which are sexually transmitted. The most common forms of HPV are types 6,
11, 16, and 18. The quadrivalent HPV vaccine that will be tested in this study has been
shown in previous studies to be effective in preventing infection with HPV 6, 11, 16, and 18
in healthy young women. According to a report by the Centers for Disease Control and
Prevention (CDC), 80% of women will have acquired HPV by the age of 50. HIV infected women
have been reported to have a higher prevalence and persistence of HPV infection, as well as
an increased risk for abnormal Pap smears and cervical cancer. HPV types 16 and 18 cause the
majority of cervical cancers worldwide, and types 6 and 11 are responsible for the majority
of cases of genital warts. Vaccinations for preventable infections are particularly
important among HIV infected people because people with HIV have compromised immune systems;
therefore, any infection is very serious and can potentially be fatal. However, standard
vaccination series have not been very successful because a compromised immune system may not
produce the desired immune response to a vaccine. The HPV vaccine is designed to protect
against infection with HPV types 6, 11, 16, and 18 and has been approved by the FDA for use
in women between the ages of 9 and 26. The purpose of this study is to determine whether the
quadrivalent HPV vaccine is safe, tolerable, and effective in producing antibodies to HPV in
HIV infected females.
This study will last 72 weeks. Participants will receive their first dose of the HPV vaccine
by intramuscular injection. The HPV vaccine will be administered again at Weeks 8 and 24.
Following each injection, participants will remain at the clinic for 30 minutes of
observation for adverse events. A phone call from or a home visit by study staff will occur
within 2 days following each injection.
Participants will return to the clinic for visits at Weeks 4, 8, 12, 24, 28, 52, and 72.
Most study visits will include a physical exam, medication review, blood and urine
collection, and answering questions about signs and symptoms since study screening. Some
visits will include measurement of HIV viral load in the cervix, a cervical brush, an anal
swab, and an oral exam. Some participants will be asked to provide additional blood samples. |
| Criteria: |
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Inclusion Criteria:
- HIV infected
- CD4 count obtained within 45 days prior to study entry
- HIV viral load levels obtained within 45 days prior to study entry by any laboratory
that has CLIA certification or its equivalent
- If receiving HAART, must be on the same HAART regimen for at least 12 weeks prior to
study entry, with no change within 30 days prior to study entry
- Willing to use acceptable forms of contraception for the duration of the study
- Written informed consent from parent or guardian, if applicable
Exclusion Criteria:
- Current (within 6 months prior to study entry) abnormal Pap test with confirmed
biopsy results of cervical intraepithelial neoplasia (CIN) II or III or cervical
cancer within 180 days prior to study entry
- History of CIN II or III or cancer confirmed by biopsy results within 180 days prior
to study entry
- Current (within 60 days prior to study entry) or history of vulval intraepithelial
neoplasia (VIN) II or III or cancer confirmed by biopsy results
- Physician-diagnosed genital warts within 180 days prior to study entry
- Previous cervical dysplasia treatment, including loop electrosurgical excision
procedure (LEEP), cervical cryotherapy, cone biopsy, and cervical laser vaporization
within 180 days prior to study entry
- 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.
Participants who have received standard of care (e.g., hepatitis B, influenza, and
tetanus) vaccines are not excluded.
- Known allergy or hypersensitivity to yeast or any components of the vaccine or its
formulation
- Current drug or alcohol use or dependence or any other condition that may interfere
with study participation
- Serious illness requiring systemic treatment and/or hospitalization within 45 days
prior to study entry
- Total hysterectomy. Participants who have undergone partial hysterectomy and have a
cervix are not excluded.
- Hemophilia
- Currently on anticoagulation therapy other than aspirin
- Prior vaccination with an HPV vaccine
- Certain abnormal laboratory values
- Pregnant or breastfeeding |
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| Study is available at: |
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Usc La Nichd Crs
Los Angeles, CA 90033
United States
Primary Contact:
Eva Operskalski, PhD
Email: eva@hsc.usc.edu
Phone: 323-226-2226 |
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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 15, 2010 |
Modifications to
this listing: |
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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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