An Open Label Demonstration Project and Phase II Safety Study of Pre-Exposure Prophylaxis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT01772823
First received: December 21, 2012
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

Approximately 200 HIV-uninfected young men who have sex with men (YMSM) at high risk of acquiring HIV infection, ages 18-22 years, inclusive, will be recruited across all participating Adolescent Medicine Trials Units (AMTU). The behavioral intervention will be assigned at the level of the site, which include Many Men, Many Voices (3MV) and Personalized Cognitive Counseling (PCC). Subjects will first complete the behavioral intervention offered at their respective site and then be provided with open label emtricitabine (FTC)/tenofovir (TDF) (Truvada®) as PrEP. Behavioral and biomedical data will be collected at baseline and 0, 4, 8, 12, 24, 36 and 48 weeks. Any subjects who become HIV infected during the course of the study will be discontinued from the study agent and followed for an additional 24 weeks after the study visit at which HIV infection is confirmed. Those subjects who meet specific bone or renal criteria at the Week 48 visit or the 24-Week HIV Seropositive visit will be followed for an additional 48 weeks in the Extension Phase to more closely monitor longer-term outcome of potential concerns.


Condition Intervention Phase
HIV Infection
Behavioral: 3MV
Behavioral: PCC
Drug: Emtricitabine/tenofovir (FTC/TDF (Truvada®))
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Project PrEPare - An Open Label Demonstration Project and Phase II Safety Study of Pre-Exposure Prophylaxis Use Among Young Men Who Have Sex With Men (YMSM) in the United States

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Change in serum creatinine from baseline, bone mineral density change from baseline, and change in behavioral disinhibition/risk compensation endpoints (e.g., number of sexual partners, number of times engaged in each type of sex act with and without condom, number of partners of each HIV serostatus, alcohol or recreational drug use before or during last sexual encounter, exchanged sex for money, drugs, food or a place to stay during last sexual encounter, HIV risk reduction measures taken with last sexual partner)

  • Acceptability, patterns of use, rates of adherence and measured levels of drug exposure when YMSM are provided open label FTC/TDF (Truvada®) and information regarding the safety and efficacy of PrEP from prior studies. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

    Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions.

    Feasibility of PrEP as measured by process indicators (e.g., number of subjects screened, number eligible, number enrolled, and number choosing to take PrEP)

    Medication adherence as measured by number of days of missed medication per total number of days, period of time that a subject's supply of study medication is assumed to be exhausted based on refill dates, and levels of drug exposure as measured by dried blood spot, plasma and peripheral blood mononuclear cell (PBMC) samples.


  • Behavioral disinhibition/risk compensation [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Changes in behavioral disinhibition/risk compensation as measured by number of sexual partners, number of times engaged in each type of sex act with and without condom, number of partners of each HIV serostatus, alcohol or recreational drug use before or during last sexual encounter, exchanged sex for money, drugs, food or a place to stay during last sexual encounter, HIV risk reduction measures taken with last sexual partner etc.


Secondary Outcome Measures:
  • Acceptability and feasibility of two types of efficacious sexual risk reduction interventions as measured by session evaluation (i.e., was session interesting, was it relevant to their life, and did they learn from the session) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Acceptability and feasibility of text message reminders as measured by subject rating of the reasons for missing medications on a 4-point Likert scale. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Demographic and/or behavioral difference between study groups. Behavioral disinhibition/risk compensation endpoints will be compared. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Explore potential demographic and/or behavioral differences between youth who are interested in participating in a PrEP study versus those who are not. Behavioral disinhibition/risk compensation endpoints will be compared. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: November 2012
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 3MV Behavioral Intervention Group
3MV Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP
Behavioral: 3MV
Many Men, Many Voices (3MV) is based on Social Cognitive Theory and the Transtheoretical Model of Behavior Change. 3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The other factors include cultural, social and religious norms, racial identity and degree of connectedness to communities, HIV/STI interactions, sexual relationship dynamics, and the social influences of racism and homophobia.
Other Name: Many Men, Many Voices
Drug: Emtricitabine/tenofovir (FTC/TDF (Truvada®))
All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Other Names:
  • FTC/TDF
  • Truvada®
  • Emtricitabine/tenofovir
  • PrEP
Experimental: PCC Behavioral Intervention Group
PCC Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP
Behavioral: PCC
Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. Counselors ask the client to recall and describe in as much detail, a recent encounter of unprotected anal sex with another man of unknown or sero-discordant HIV status. The client then identifies and expresses thoughts, feelings, or attitudes that might have led to the high-risk behavior. The client and counselor examine and identify thoughts that may have led the client to decide to engage in high transmission risk sex. The client and counselor agree on strategies that can be used to deal with similar situations in the future.
Other Name: Personalized Cognitive Counseling
Drug: Emtricitabine/tenofovir (FTC/TDF (Truvada®))
All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Other Names:
  • FTC/TDF
  • Truvada®
  • Emtricitabine/tenofovir
  • PrEP

Detailed Description:

The primary objectives of the study are to provide additional safety data regarding FTC/TDF (Truvada®) use as PrEP in YMSM, to examine acceptability, patterns of use, rates of adherence, measure levels of drug exposure and patterns of risk behavior when YMSM are provided open label FTC/TDF (Truvada®). The study will also examine information regarding safety and efficacy of PrEP from prior studies.

  Eligibility

Ages Eligible for Study:   18 Years to 22 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Willing and able to provide written informed consent;
  • Male gender at birth;
  • Age 18 years and 0 days through 22 years and 364 days, inclusive, at the time of signed informed consent;
  • Self reports evidence of high risk for acquiring HIV infection including at least one of the following:

    • At least one episode of unprotected anal intercourse with an HIV-infected male partner or a male partner of unknown HIV status during the last 6 months;
    • Anal intercourse with 3 or more male sex partners during the last 6 months;
    • Exchange of money, gifts, shelter, or drugs for anal sex with a male partner during the last 6 months;
    • Sex with a male partner and has had a sexually transmitted infection (STI) during the last 6 months or at screening;
    • Sexual partner of an HIV-infected man with whom condoms were not consistently used in the last 6 months; or
    • At least one episode of anal intercourse where the condom broke or slipped off during the last 6 months;
  • Tests HIV antibody negative at time of screening;
  • Willing to provide locator information to study staff;
  • Willing to take pre-exposure prophylaxis (PrEP);
  • Willing to participate in behavioral intervention;
  • Reports intention not to relocate out of the Adolescent Medicine Trial Unit (AMTU) study area during the course of the study; and
  • Does not have a job or other obligations that would require long absences from the AMTU study area (greater than 4 weeks at a time).

Exclusion Criteria:

  • Appears visibly distraught or presence of active serious psychiatric symptoms (e.g., active hallucinations, suicidal, homicidal, or exhibiting violent behavior) at the time of consent;
  • Intoxicated or under the influence of alcohol or other drugs at the time of consent;
  • Any significant uncontrolled, active or chronic disease process that, in the judgment of the site investigator, would make participation in the study inappropriate. (Appropriately managed conditions, like well-controlled diabetes, would not preclude enrollment; the site is encouraged to contact the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) 110 Protocol Team if they are having difficulty making the judgment.);
  • History of bone fractures not explained by trauma;
  • Acute or chronic hepatitis B infection as indicated by positive hepatitis B surface antigen (sAg) test at time of screening;
  • Confirmed renal dysfunction (Creatinine Clearance (CrCl) < 75 ml/min, or serum creatinine ≥ upper limit of normal (ULN), or history of renal parenchymal disease or presence of only one kidney at time of screening;
  • Confirmed ≥ Grade 2 hypophosphatemia at time of screening;
  • Confirmed ≥ Grade 2 hematologic system abnormality (White Blood Count (WBC), Absolute Neutrophil Count (ANC), hemoglobin, or platelets) at time of screening;
  • Confirmed ≥ Grade 2 hepatobiliary system abnormality (Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), or bilirubin) at time of screening;
  • Confirmed proteinuria as indicated by urine dipstick result ≥ 1+ at time of screening, regardless of urine protein to creatinine ratio(UP/C);
  • UP/C > 0.37 g/g at time of screening, regardless of urine dipstick protein result;
  • Confirmed normoglycemic glucosuria as indicated by urine dipstick result ≥ 1+ in the presence of normal serum glucose (<120 mg/dL) at time of screening;
  • A confirmed Grade ≥ 3 toxicity on any screening evaluations;
  • Known allergy/sensitivity to the study agent or its components;
  • Concurrent participation in an HIV vaccine study or other investigational drug study, including oral or topical PrEP (microbicide) studies;
  • Use of disallowed medications ; or
  • Inability to understand spoken English.
  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: NCT01772823

Locations
United States, California
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027
United States, Colorado
University of Colorado - The Children's Hospital of Denver
Aurora, Colorado, United States, 80045
United States, Florida
University of Miami
Miami, Florida, United States, 33101
University of South Florida
Tampa, Florida, United States, 33606
United States, Illinois
Stroger Hospital and the CORE Center
Chicago, Illinois, United States, 60612
United States, Louisiana
Tulane University
New Orleans, Louisiana, United States, 70112
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Fenway Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48201
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
St. Jude Childrens Research Hospital
Memphis, Tennessee, United States, 38105
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Investigators
Study Chair: Sybil Hosek, PhD John Stroger Hospital of Cook County
  More Information

Additional Information:
No publications provided

Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT01772823     History of Changes
Other Study ID Numbers: ATN 110 Version 2.0
Study First Received: December 21, 2012
Last Updated: May 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
HIV, PrEP, FTC/TDF, Truvada

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

ClinicalTrials.gov processed this record on September 29, 2014