Study of Tenofovir Disoproxil Fumarate (TDF) for Prevention of HIV
HIV Infections
About this trial
This is an interventional prevention trial for HIV Infections focused on measuring AE adverse event, AIDS acquired immunodeficiency syndrome, ALT (SGPT) alanine aminotransferase, ART antiretroviral therapy, AST (SGOT) aspartate aminotransferase, DCF data collection forms, DMC Data Monitoring Committee, FDA (U.S.) Food and Drug Administration, GCP Good Clinical Practice guidelines, HB sAg Hepatitis B surface antigen, ICH International Conference of Harmonisation, IND Investigational New Drug Application, IRB Institutional Review Board, IU international units, mg milligram(s), mm3 cubic millimeter(s), PCR polymerase chain reaction, SAE serious adverse event, µg microgram, ULN upper limit of the normal range, WB Western Blot, Human Immunodeficiency Virus
Eligibility Criteria
Inclusion Criteria: HIV seronegative Willing and able to give informed consent 18 years to 35 years old, inclusive Sexually active (on average, coitus 3 times per week) Have had more than three sexual partners in the last month Willing to use study product as directed Willing to adhere to follow-up schedule Willing to participate in the study for up to 12 months Not pregnant, breast feeding, or desiring a pregnancy during the 12 months of participation Have adequate renal function (serum creatinine < 1.5 mg/dL) Have adequate liver function (hepatic transaminases [ALT and AST] < 43 U/L) Have adequate serum phosphorus (greater than or equal to 2.2 mg/dL) In general good health (no active, serious infections that require parenteral antibiotics; no active clinically significant medical conditions, including heart disease, diabetes, asthma, alcoholism, and cancer)
Sites / Locations
- Care and Health Program
- Virtual Access
- University of College Hospital