FEM-PrEP (Truvada®): Study to Assess the Role of Truvada® in Preventing HIV Acquisition in Women

Inclusion Criteria

• Willing and able (see criterion 2) to provide written informed consent to be screened for and to participate in the trial
• Able to answer a percentage of informed consent screening (75%) and enrollment (100%) comprehension quiz questions correctly
• Between 18-35 years old, inclusive
• At higher risk of becoming HIV infected
• Have a final negative result according to the site-specific screening HIV testing algorithm and a final negative result at enrollment according to the study HIV testing algorithm
• Willing to participate in all aspects of the study and to comply with study procedures, for up to 60 weeks, including:
• Be randomized
• Use study product as directed
• Adhere to follow-up schedule and willing to be contacted by site staff between study visits (by phone and/or in person)
• Use a study-approved effective non-barrier method of contraception for the duration of the study
• Take study product, as evidenced by swallowing a vitamin tablet that is similar in size to the study product at enrollment
• Provide contact information and agrees to some form of contact method throughout the study
• Not intending to relocate out of the area for the duration of the study participation and does not have a job or other obligations that may require long absences from the area ( > 1 month at a time)
• In general good health and have no condition (social or medical) which, in the opinion of the Site Investigator, would make study participation unsafe or complicate data interpretation
• Not pregnant or breastfeeding, and does not anticipate a desire for pregnancy during the 52 weeks of on-product participation
• Medically eligible at screening including:
• Adequate renal function (serum creatinine ≤ upper limit of normal (ULN) of local range and creatinine clearance ≥ 60ml/min estimated by the Cockcroft-Gault Creatinine Clearance Formula
• Adequate hepatic function (hepatic transaminases ALT and AST < 2x ULN [according to local normal ranges])
• HBsAg negative
• Serum phosphorus levels above the lower limit of the local normal range (according to local normal ranges - grade 3 & 4 hypophosphatemia will be excluded even if within normal local ranges)
• Not received or receiving an experimental HIV vaccine, participating in another HIV prevention study or participating in any other clinical trial with a biomedical intervention
• No clinical signs of liver disease (e.g., ascites, spider angiomata, hepatomegaly, jaundice)
• No definite evidence of glycosuria or proteinuria (i.e., no repeated positive [ ≥ + 1 ] urine dipstick). If a urine dipstick is positive for either glucose and/or protein at the first test, a second urine sample will be tested.
• No history of pathological bone fractures
• No history of adverse reaction to latex
• Not taking any of the following medications: nephrotoxic agents; aminoglycoside antibiotics (including gentamicin); intravenous (IV) amphotericin B; cidofovir; cisplatin; foscarnet; IV pentamidine; oral or IV vancomycin; oral or IV gancyclovir; other agents with significant nephrotoxic potential; drugs that slow renal excretion; probenecid; immune system modulators; systemic chemotherapeutic agents (i.e. cancer treatment medications); systemic corticosteroids; interleukin-2 (IL-2); immunomodulators; interferon (alpha, beta, or gamma); other antiretrovirals (including nucleoside analogs, non-nucleoside reverse transcriptase inhibitors, protease inhibitors or investigational antiretroviral agents)