Evaluating the Acceptability, Safety, and Use of Daily Truvada Pre-Exposure Prophylaxis in Healthy, HIV-Uninfected Adolescents

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Truvada (emtricitabine/tenofovir disoproxil fumarate, or FTC/TDF) is a type of antiretroviral (ARV) medicine that is commonly used to treat HIV. Truvada is also used as pre-exposure prophylaxis (PrEP) to prevent HIV infection in HIV-negative adults. The purpose of this study is to evaluate the acceptability, safety, and use of daily Truvada PrEP as part of a comprehensive HIV prevention package in healthy, HIV-uninfected adolescents 15 to 19 years of age.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Tenofovir

Criteria

Inclusion Criteria:

• Age 15 to 19 years (inclusive) at screening, verified per study site standard operating procedures (SOPs)

• Able and willing to provide written informed consent/assent (age dependent) to be screened for and to take part in the study

• Have a guardian who is able and willing to provide written informed consent for his or her child to be screened for and to take part in the study

• Able and willing to provide adequate locator information, as defined in site standard operating procedures (SOPs)

• HIV-uninfected based on testing performed by study staff at screening and enrollment

• Sexually active, as defined as a minimum of one act of (penile vaginal) sexual intercourse in the last 12 months, per self-report

• (For female participants) Negative pregnancy test at screening and enrollment and, per participant report, does not intend to become pregnant in the next 12 months

• (For female participants) Using an effective method of contraception at enrollment, and intending to use an effective method for the study duration; effective methods include low dose oral, implant, or injectable hormonal methods.

• Does not report intention to relocate out of the study area during the course of the study

• Does not have job or other obligations that would require long absences from the area (for more than 4 weeks at a time)

• Willing to undergo all study-required procedures

• At screening and enrollment, agrees not to participate in other research studies involving drugs or medical devices for the next 12 months

Exclusion Criteria:

Participants who meet any of the following criteria, at baseline, are excluded from the study:

• As determined by the Site Investigator, any significant uncontrolled active or chronic disease process such as but not limited to diabetes, hypertension, and other diseases involving the cardiovascular, pulmonary, gastrointestinal, genitourinary, musculoskeletal, and central nervous systems

• Confirmed Grade 2 or greater hypophosphatemia

• Presence of serious psychiatric symptoms (e.g., active hallucinations)

• Visibly distraught at the time of consent (e.g., suicidal, homicidal, exhibiting violent behavior)

• Intoxicated or under the influence of alcohol or other drugs at the time of consent

• Acute or chronic hepatitis B infection (i.e., if hepatitis B surface antigen positive)

• Hepatitis B seronegative and refuses vaccination

• Renal dysfunction (creatinine clearance less than 75 ml/min); Use Cockroft-Gault equation as detailed in the protocol

• Urine dipstick for protein and glucose, excluding values of "1 +" or greater

• Any history of bone fractures not explained by trauma

• Any Grade 2 or greater toxicity on screening tests and assessments

• Concurrent participation in an HIV vaccine study or other investigational drug study

• Known allergy/sensitivity to the study drug or its components

• Use of disallowed medications (as detailed in the protocol)