Acceptability, Safety, and Use of Daily Truvada Pre-Exposure Prophylaxis in Adolescents

NCT02213328 | Completed Phase 2 Results DMC

• 2 other identifiers: CHAMPS PrEP11931
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (5)

• The Percentage of Participants Who Report Willingness to Use the Study Regimen, Take up PrEP, and Remain on PrEP as Part of a Comprehensive Prevention Package

  The percentage of participants who report willingness to use the study regimen, take up PrEP, and remain on PrEP as part of a comprehensive prevention package measured at different time points in the study

  Measured through Week 48

• Number of Participants With Acceptability as Per Questionnaire Administered at Week 48

  Acceptability was assessed by asking partcipants if they liked truvada, at the week 48 visit

  Measured at Week 48

• Number of Adolescents Who Continue to Use PrEP (as Indicated by Dried Blood Spot [DBS] Levels) After the Initial 3-month Period

  Number of adolescents who continued to use PrEP (as indicated by dried blood spot level) after the initial 3-month period as indicated by DBS at week 24/36/48

  Measured through Week 48

• Number of Participants With Grades 2, 3, and 4 Clinical and Laboratory Adverse Events

  Assessment of Grades 2, 3, and 4 clinical and laboratory adverse events measured through week 48 using the DAIDS table for grading adult and paediatric adverse events, dated Dec 2004, (clarification Aug 2009). Expedited Adverse Event (EAE) reporting followed standard reporting requirements as defined in the DAIDS Manual for Expedited Reporting of Adverse Events version 2·0, March 2011.

  Measured through Week 48

• Number of Adolescents Enrolled and Retained in the Study

  Count of participants who had been enrolled in the study and successfully completed the study

  Measured through Week 52

Secondary Outcomes (6)

• Number of Participants Who Used PrEP at Any Time Point During the Study, Measured With Drug Levels at M4/8/12/24/36

  Measured through Week 48

• Proportion of Adolescents With Detectable Drug Levels Who Report Using PrEP

  Measured though Week 48

• Number of Participants Reporting Multiple Partners in the Preceding Year as Evidenced by Participant Responses to Interviewer Administered Questionnaires at Enrolment

  Baseline

• Reported Consistent Condom Use as Evidenced by Participant Responses to Interviewer-administered Questionnaires Adminstered at the Enrolment Visit

  Baseline

• Reported Alcohol and Substance Use as Evidenced by Participant Responses to Interviewer-administered Questionnaires at the Enrolment Visit

  Baseline visit

Study Arms (1)

Truvada

EXPERIMENTAL

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

Interventions

Truvada DRUG

Fixed-dose combination tablet containing 200 mg of FTC plus 300 mg of TDF, taken once daily by mouth.

Also known as: emtricitabine/tenofovir disoproxil fumarate, FTC/TDF

Truvada

Eligibility Criteria

• Age: 15 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (2)

Desmond Tutu HIV Foundation Non-Network CRS

Cape Town, South Africa

Location

Perinatal HIV Non-network Research CRS

Soweto, 1862, South Africa

Location

Related Publications (1)

• Gill K, Johnson L, Dietrich J, Myer L, Marcus R, Wallace M, Pidwell T, Mendel E, Fynn L, Jones K, Wiesner L, Slack C, Strode A, Spiegel H, Hosek S, Rooney J, Gray G, Bekker LG. Acceptability, safety, and patterns of use of oral tenofovir disoproxil fumarate and emtricitabine for HIV pre-exposure prophylaxis in South African adolescents: an open-label single-arm phase 2 trial. Lancet Child Adolesc Health. 2020 Dec;4(12):875-883. doi: 10.1016/S2352-4642(20)30248-0. Epub 2020 Oct 24.

  PMID: 33222803 DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Emtricitabine; Tenofovir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr Katherine Gill
• Organization: Desmond Tutu HIV Foundation

katherine.gill@hiv-research.org.za

+2721 785 3121

Study Officials

• Linda-Gail Bekker, MBChB, PhD

  Desmond Tutu HIV Centre

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2014
• First Posted: August 11, 2014
• Study Start: April 1, 2015
• Primary Completion: March 6, 2017
• Study Completion: March 6, 2017
• Last Updated: July 3, 2023
• Results First Posted: July 3, 2023

Record last verified: 2023-06

Locations

ZA (2)