Human papillomavirus (HPV) infection is the most common sexually transmitted disease (STD) worldwide. There are over 90 types of HPV that infect humans.  Some of these types infect the genital and anal areas where the infection causes genital and anal warts.  It also causes cancer of the cervix (opening of the uterus) in females. Merck & Co., Inc. makes a quadrivalent HPV vaccine called Gardasil. Quadrivalent means that this vaccine is directed at four types of HPV. This vaccine does not protect people against other types of HPV, other STDs or HIV.  This vaccine has been approved by the FDA for use in females 9 to 26 years old.

This study will see if the HPV vaccine, when given in three separate doses, is safe and can be tolerated by females infected with HIV.  The study will also look at if the HPV vaccine can help the body make substances in response to the vaccination to help fight off disease.  This is the first time Gardasil is being tested in females with HIV.  Since the vaccine is made with parts that are like the HPV virus, but not with the virus itself, it cannot cause HPV disease. Study Duration: 72 weeks.

 

Inclusion Criteria:

• HIV positive women between the ages of 18 and 45
• If currently on antiretroviral therapy (ART), on stable therapy for 3 months or longer prior to study entry with no changes to regimen for 30 days prior to study entry
• Standard laboratory results must be within normal ranges within 45 days prior to study entry

Exclusion criteria:

• Currently pregnant or breastfeeding
• Current or history of cervical cancer or cervical or vaginal intraepithelial neoplasia II or III
• Physician diagnosed genital warts within 180 days prior to study entry
• Previous cervical dysplasia treatment
• 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.
• Known allergy/sensitivity or any hypersensitivity to yeast or components of study treatment or its formulation.
• Serious illness requiring systemic treatment and/or hospitalization within 45 days prior to study entry
• Hemophilia or currently on anticoagulation therapy other than aspirin
• Prior vaccination with an HPV vaccine

This study is being conducted by Dr. Ardis Moe under IRB #08-01-060-01

If you think you might be interested in participating in this study, please contact Deon Claiborne at 310-557-9062 or email at dclaiborne@mednet.ucla.edu

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