Counseling an HIV Clinical Trial Participant

 Overview


Clinical trial participants and families are counseled about every phase of a clinical trial. In this module, you take the role of a clinical trial project counselor to work through the trial protocol and answer questions brought to you by the parents of a 15 year-old HIV positive participant.

 

Scenario


Your work as one of the program coordinators for a clinical trials team at a major health research facility involves quite a few different tasks. Each one is important to moving a clinical trial to a successful completion.  Although you love your job, some tasks are harder than others.  Today, one of your assignments is to prepare to counsel parents of a prospective underage clinical trial participant.

Your up-coming appointment is with parents of a 15-year old male who is HIV-positive.  The teen would seem to fit well into a clinical trial being conducted at your facility. You need to review all information provided in the trial description to make sure the teen does indeed fit the criteria and you need to be fully aware of the specific protocol for this clinical trial. 

You also need to evaluate the parents to see if they are suitable for involvement of their  son in this clinical trial. Parents of minor participants play a crucial role in the success of the participation. Both parents and the minor participant need to be fully aware and completely knowledgeable of the specifics involved in clinical trial protocol.

The parents have already submitted a partial list of questions for you. The son will be interviewed at a later date.

Read the clinical trial description below and research any information needed to be fully prepared to brief them on clinical trial protocol. The parents have already submitted a list of questions for you. Be prepared to respond to each of these questions in addition to ones which will come up during the interview. 

Mr. and Mrs. Hoover wrote their questions down last night so they didn’t forget even one of them. They say they have been very upset ever since they found out about David’s positive HIV test. They know that HIV is still a death sentence; there is no cure for HIV. They know that HIV/AIDS patients are living longer now and that if David can just live longer, maybe there will be a cure.

Their questions:

  • What does Phase III mean? If this is Phase III, did he miss anything by not starting in Phase I?
  • What happened in Phase I and Phase II? 
  • There is no risk to this, is there? We just want to make sure there is no risk for David.  
  • When will we see that there has been an improvement?
  • If there is no improvement, can he go on a different drug?
  • Is there anyone else from his school or this city that is in the trial?
  • How long will the trial last?
  • What happens when it is over?
  • What happens if he gets sick on the medicine and can’t take it?

Clinical Trial Information:

The Safety and Effectiveness of Combinations of Three Anti-HIV Drugs in the Treatment of HIV-Infected Teens: Phase III

Background Information
The presence of human immunodeficiency virus (HIV) can lead to acquired immunodeficiency syndrome (AIDS).  The immune system begins to fail with the development of AIDS which leads to life-threatening infections the patient can no longer fight.

HIV infection is now pandemic (worldwide) At the end of 2007, it is estimated that 33 million people worldwide lived with HIV/AIDS, making it one of the most destructive pandemics in history.

Research and testing has found that combinations of anti-viral medications can reduce HIV viral loads thereby slowing the disease progression.  Today’s anti-viral medications have greatly lengthened the life expectancy of patients with HIV infections even after the HIV has progressed to AIDS.  With anti-viral therapy life expectancy in some patients can be more than 5 years; without anti-viral therapy, death normally occurs within a year. 

 


Sponsors and Collaborators

Center for Drug Evaluation, Research, and Clinical Trials

U.S. Department of Health and Human Services

Center for Biologics Evaluation and Research (CBER) 

Information Provided by

Center for Drug Evaluation, Research, and Clinical Trials 

Purpose
The purpose of this Phase III trial is to find out the most effective combination of 3 drugs for use in the treatment of HIV-infected teens.

The effectiveness will be evaluated by measuring levels of HIV loads in the blood. Decreasing HIV levels are an indication that the disease progression is being slowed.

Drugs:

  • Lexiva (Fosamprenavir)
  • Trizivir
  • Efavirenz

Phase III

Trial Design

This study will monitor five treatment arms. Participants will be randomized into five groups: groups for combinations of the test drugs fosamprenavir, trizivir, and efavirenz and a placebo control group. Effectiveness will be measured by possible decrease in HIV loads. Each group will be measured once a month for 48 weeks.

Treatment arms:

  • Group A—fosamprenavir, trizivir, and efavirenz
  • Group B—fosamprenavir, trizivir 
  • Group C—fosamprenavir efavirenz
  • Group D—trizivir, and efavirenz
  • Group E—control + placebo 

Eligibility

Ages eligible for participation: 13 to 17 years old
Genders eligible for participation: Both
Accepts healthy volunteers for participation: No
 

Inclusion criteria

  • Must be HIV-positive
  • Ages 13 to 17 years
  • Have parental permission or guardian permission to participate
  • Have received the same HIV treatment for the past 12 months or have been newly diagnosed
  • Agree to testing as described in the trial information
  • Parents sign the informed consent

Exclusion criteria

  • Are not within the age limit as described in the trial information
  • Are currently taking anti-HIV drugs and will not discontinue the drugs
  • Currently have serious infections or conditions (for example, cancer, pneumonia)
  • Are pregnant

Study Type

Interventional

Study Design

Treatment, Drug Study

Estimated Enrollment

1,000—3,000

Study Methodology

Randomized, controlled

Primary Outcome Measures
To Be Measured: Complete blood counts with differential (description of size and shape of cells), HIV blood viral loads, patient vital signs and statistics (temperature, pulse rate, blood pressure, respiration rates, height, and weight)

Blood work and vital statistics will be measure every month for 48 weeks.

Description:
Anti-viral therapy is associated with lower blood viral loads and delayed clinical progression of HIV disease. This study investigates the effect of four different combinations of anti-viral drugs on HIV viral load and progression of disease. 

  • Combinations have been identified using results of previous studies and Phase I and II trials.
  • A control group using a placebo is also measured over the course of the trial.
  • Measurements include results of blood studies, including blood cell counts, blood cell morphology (size and shape), and HIV viral load.
  • Treatment with experimental combinations will continue for 48 weeks with measurements being taken every 4 weeks. At 48 weeks, data will be collected and analyzed. Patients with clinically stable viral loads with no adverse side effects can extend the treatment regimen for an additional 48 weeks. At 96 weeks, Phase III will end and final data will be collected. Data will be analyzed and recommendations made prior to Phase IV testing, if it occurs.

Contacts
Marie Adams  304.555.2094  madams@aveu.edu/ctru
Jenna Anne Christopher  304.555.2095  jchristopher@aveu.edu/ctru

Locations
Mary Babb Randolph Cancer Center    West Virginia University   Morgantown, West Virginia

Clinical Trials Research Center    University of Virginia   Charlottesville, Virginia
University of Colorado Health Science Center    Clinical Trials Research Center   Denver, Colorado
The Ohio State University   College of Medicine Division of Infectious Diseases Columbus, Ohio
Thomas Jefferson University Hospital   Clinical Trials Unit  Philadelphia, Pennsylvania
University of Southern California  Keck School of Medicine   Los Angeles, California
  
Investigator
Principal Investigator:  Lynn Calinger   Mary Babb Randolph Cancer Center    West Virginia University   Morgantown, West Virginia   304.555.5449    lcalinger@wvu.edu/clintrial