Safety and Effectiveness of TFV 1% Gel, TDF Tablets, and FTC/TDF Tablets in Preventing HIV in Women

Inclusion Criteria:

• Willing to provide adequate locator information
• Sexually active, defined as having vaginal intercourse at least once in the 3 monthsprior to screening
• Agree to not participate in other research studies involving drugs, medical devices,or vaginal products for duration of study.
• Agree to use effective method of contraception. More information on this criterion canbe found in the protocol.

Exclusion Criteria:

• HIV infected
• Known adverse reaction to any of the study products
• Known adverse reaction to latex
• Pathologic bone fracture not related to trauma
• Non-therapeutic injection drug use in the 12 months prior to screening
• Post-exposure prophylaxis for HIV exposure within 6 months prior to enrollment
• Last pregnancy outcome 42 days or less prior to enrollment
• Gynecologic or genital procedure 42 days or less prior to enrollment
• Participation in any other research study involving drugs, medical devices, or vaginalproducts 30 days or less prior to enrollment
• Currently using spermicide, interferon or interleukin therapy, or certain medications.More information on this criterion can be found in the protocol.
• Any significant uncontrolled active or chronic disease. More information on thiscriterion can be found in the protocol.
• Certain abnormal laboratory values. More information on this criterion can be found inthe protocol.
• Intends to become pregnant in the 24 months after enrollment
• Plans to relocate or travel away from the study site for more than 8 consecutive weeksin the 24 months after enrollment
• Urinary tract infection
• Pelvic inflammatory disease, an STI, or reproductive tract infection requiringtreatment
• Grade 2 or higher pelvic exam finding
• Any condition that, in the opinion of the investigator, would interfere with the study
• Pregnant or breastfeeding