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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2014 by National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT02213328
First received: August 7, 2014
Last updated: September 11, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Truvada
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: CHAMPS: Choices For Adolescent Prevention Methods For South Africa. Pilot Study B: 'PlusPills' A Demonstration Open Label Study to Assess the Acceptability and Use of Truvada Pre-exposure Prophylaxis in Healthy, HIV-Uninfected Adolescents, 15-19 Years of Age

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • The proportion of participants who report willingness to use the study regimen, take up PrEP, and remain on PrEP as part of a comprehensive prevention package [ Time Frame: Measured through Week 52 ] [ Designated as safety issue: No ]
  • Assessment of acceptability as per questionnaire administered at study end [ Time Frame: Measured through Week 52 ] [ Designated as safety issue: No ]
  • Number of adolescents who continue to use PrEP (as indicated by dried blood spot [DBS] levels) after the initial 3-month period [ Time Frame: Measured through Week 52 ] [ Designated as safety issue: No ]
  • The total time on PrEP (as indicated by DBS levels) for each adolescent who indicated PrEP use by self-report at the beginning of each 3-month period [ Time Frame: Measured through Week 52 ] [ Designated as safety issue: No ]
  • The total time on PrEP (as indicated by DBS levels) for the cohort as a whole in those individuals who indicated PrEP use by self-report at the beginning of each 3-month period [ Time Frame: Measured through Week 52 ] [ Designated as safety issue: No ]
  • Assessment of Grades 2, 3, and 4 clinical and laboratory adverse events [ Time Frame: Measured through Week 52 ] [ Designated as safety issue: Yes ]
  • Number of adolescents recruited, enrolled, and retained in the study [ Time Frame: Measured through Week 52 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of adherence to daily regimens of oral PrEP as evidenced by the use of self-report, pill counts, and proportion of participants on Truvada who have detectable drug levels [ Time Frame: Measured through Week 52 ] [ Designated as safety issue: No ]
  • Proportion of blood samples with detectable drug levels [ Time Frame: Measured through Week 52 ] [ Designated as safety issue: No ]
  • Proportion of adolescents with detectable drug levels who report using PrEP [ Time Frame: Measured though Week 52 ] [ Designated as safety issue: No ]
  • Proportion of doses that are taken as instructed [ Time Frame: Measured through Week 52 ] [ Designated as safety issue: No ]
  • Reported number of steady and casual sex partners as evidenced by participant responses to interviewer-administered questionnaires and focus groups [ Time Frame: Measured through Week 52 ] [ Designated as safety issue: No ]
  • Reported condom use (and change after introduction of study product) as evidenced by participant responses to interviewer-administered questionnaires and focus groups [ Time Frame: Measured through Week 52 ] [ Designated as safety issue: No ]
  • Reported substance use prior to or during sex as evidenced by participant responses to interviewer-administered questionnaires and focus groups [ Time Frame: Measured through Week 52 ] [ Designated as safety issue: No ]
  • Proportion of scheduled HIV testing appointments missed, in relation to individual characteristics (age, sex, number of partners, use of other prevention methods) and the characteristics of the product [ Time Frame: Measured through Week 52 ] [ Designated as safety issue: No ]
  • Frequency of HIV infection as measured by seroconversion of study participants during the approximate 12 months of follow up [ Time Frame: Measured through Week 52 ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Truvada
All participants will take Truvada, once daily by mouth for the first 12 weeks of the study. After Week 12 of the study, only participants who indicate a willingness to use Truvada PrEP and who do not have any medical reasons not to do so will continue to receive the Truvada tablets through Week 52.
Drug: Truvada
Fixed-dose combination tablet containing 200 mg of FTC plus 300 mg of TDF, taken once daily by mouth.
Other Name: emtricitabine/tenofovir disoproxil fumarate, FTC/TDF

Detailed Description:

Truvada PrEP is an approach used to protect HIV-uninfected adults against possible infection with HIV. The approach involves taking Truvada every day to prevent HIV infection in case the person is exposed to HIV (for example, through sex with an HIV-infected person). 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 old. In addition to Truvada PrEP, the HIV prevention package will include HIV testing, management of sexually transmitted infections (STIs), risk reduction counseling, access to condoms, post-exposure prophylaxis (PEP), and circumcision counseling and referral for male participants.

The study will enroll 150 healthy, HIV-uninfected adolescents 15 to 19 years of age. The study will last for 12 months (52 weeks) and involve scheduled clinic visits at study entry (Week 0) and Weeks 4, 8, 12, 24, 36, 48, and 52.

For the first 12 weeks of the study, all participants will be provided with a supply of Truvada tablets to take once daily as part of the comprehensive HIV prevention package. At Weeks 12, 24, 36, and 48, participants will be offered the following options: to continue with the full HIV prevention package plus Truvada PrEP, to stop Truvada PrEP and continue with rest of the HIV prevention package, or to re-start Truvada PrEP if previously stopped. After Week 12 of the study, Truvada tablets will be given only to those participants who decide to take PrEP and who do not have any medical reasons not to do so. Regardless whether they choose to use Truvada PrEP after Week 12, all study participants will be followed through Week 52 of the study.

All study visits will include blood collection, counseling before and after HIV testing, urine collection for pregnancy testing (female participants only), completion of a sexual risk behavior questionnaire, receipt of a supply of condoms, contraceptive counseling, a medical history review, and disclosure of available test results. Select study visits may include a physical exam, blood and urine collection, testing and treatment of STIs, adherence counseling, and an acceptability assessment. Between Months 11 and 12 of the study, some participants will be randomly selected to participate in focus groups to discuss their experiences while taking Truvada PrEP.

  Eligibility

Ages Eligible for Study:   15 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 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: glomerular filtration rate (GFR) equal to (140 minus age in years) multiplied by (weight in kilograms) divided by (72 multiplied by serum creatinine)
  • 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 (to be specified)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02213328

Sponsors and Collaborators
Investigators
Principal Investigator: Linda-Gail Bekker, MBChB, PhD Desmond Tutu HIV Centre
  More Information

No publications provided

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT02213328     History of Changes
Other Study ID Numbers: CHAMPS PrEP, 11931
Study First Received: August 7, 2014
Last Updated: September 11, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Tenofovir
Tenofovir disoproxil
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014