A5240 - Immunogenicity and Safety of a Quadrivalent HPV Vaccine in HIV-1-Infected Females

Eligible candidates:

• HIV positive females, ages 16 to 45
• If you are taking antiretroviral drugs, you must be on the same combination of medicines for at least 12 weeks before the study entry visit. You do not need to be on antiretroviral drugs to be eligible for this study.
• No cervical cancer, very abnormal Pap smear, or genital warts within 180 days
• No prior vaccinations for HPV
• Additional requirements will be discussed by the study nurse or doctor

Study Objective:
The FDA has approved an HPV vaccine (called Gardasil), and it is directed against 4 types of HPV which are the most common causes of genital warts and cervical cancer. This study is the first of its kind to test the HPV vaccine in females infected with HIV.
This study will see if the HPV vaccine, when given in 3 separate doses, is safe and tolerable in females infected with HIV. This will be done by asking how you feel and if you had any reactions after each dose of the vaccine. The study will also check if the HPV vaccine can help the body make substances in response to the vaccination to help fight off disease caused by HPV.

Study Scheme:
This is an open-label, single arm study with stratification by CD4 cell count and HIV-1 RNA viral load. A total of 402 people will be enrolled in the study, and each patient will be on the study for approximately 72 weeks.

Study Drugs:

• Gardasil (HPV vaccine)

Study Status: Open to enrollment.

Study Staff:

• Judith Aberg, MD
• Janet Forcht, RN
• Margie Vasquez, RN
• Luis Vargas

Study Sponsors:

• AIDS Clinical Trials Group (NIH)

Study Volunteers Receive:

• Cost-free vaccinations and lab work
• Transportation reimbursement