The Effect of Teaching HIV-Infected Patients About HIV and Treatment

A Phase IIIB, Open-Label, Randomized Study of the Effect of an Education Intervention on Virological Outcomes, Adherence, Immunological Outcome, and Health Outcomes in HIV-Infected Subjects From Under-Represented Populations Treated With Triple Nucleoside Therapy (Combivir, Lamivudine 150 Mg/Zidovudine 300 Mg PO BID Plus Abacavir 300 Mg PO BID) for Twenty-Four Weeks

The purpose of this study is to see if an HIV-education course can help under-represented, HIV-infected patients. This study examines the areas of faithfulness to drug regimen, level of HIV in the blood, and health status.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Drug: Abacavir sulfate; Drug: Lamivudine/Zidovudine

Detailed Description

Following initial screening, eligible patients are treated with open-label Combivir plus abacavir for 24 weeks. Patients are randomized to undergo the education intervention, Tools for Health and Empowerment (T.H.E.) course plus counseling, or routine counseling only (control group). Measurements and evaluations for assessment of immunologic effects, adherence, and health outcomes are performed at entry (Day 1) and at Weeks 2, 5, 8, 12, 16, and 24.

• Study Type: Interventional
• Enrollment: 200
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90027
      • AIDS Healthcare Foundation
    • Los Angeles, California, United States, 90059
      • Oasis Clinic / King Drew Med Ctr
    • Oakland, California, United States, 94609
      • Robert Scott MD
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Georgetown Univ Med Ctr
    • Washington, District of Columbia, United States, 20009
      • Whitman Walker Clinic/Elizabeth Taylor Med Ctr
  • Florida
    • Miami, Florida, United States, 33136
      • Univ of Miami School of Medicine
    • Miami, Florida, United States, 33142
      • Specialty Med Care Ctrs of South Florida Inc
    • Tampa, Florida, United States, 33607
      • Saint Josephs Comprehensive Research Institute
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • AIDS Research Consortium of Atlanta
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush Med College / Dept of Infectious Diseases
    • Oak Park, Illinois, United States, 60301
      • Encounter Med Group
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • New England Med Ctr / Div of Geo Med & Infect Disease
  • New Jersey
    • Newark, New Jersey, United States, 07103
      • Jeffrey Bomser Clinic / NJCR
    • Newark, New Jersey, United States, 07103
      • UMDNJ / Dept of Ob/Gyn
    • Newark, New Jersey, United States, 07114
      • Newark Community Health Ctr
  • New York
    • Brooklyn, New York, United States, 11201
      • Addiction Research and Treatment Corp
    • New York, New York, United States, 10011
      • Bentley-Salick Med Practice
  • Ohio
    • Cincinnati, Ohio, United States, 452670405
      • Holmes Hosp / Univ of Cincinnati Med Ctr
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19102
      • Allegheny Univ of the Hlth Sciences / Div of Infect Diseases
  • South Carolina
    • Denmark, South Carolina, United States, 29042
      • Carolina Family Care/Denmark Med Ctr / P O Box 278
  • Tennessee
    • Memphis, Tennessee, United States, 38103
      • Univ of Tennessee
    • Memphis, Tennessee, United States, 38165
      • Univ of Tennessee / Div of Infect Dis / Dept of Med
  • Texas
    • Dallas, Texas, United States, 75217
      • Southeast Dallas Health Ctr
    • Houston, Texas, United States, 77004
      • Therapeutic Concepts
    • San Antonio, Texas, United States, 78205
      • Santa Rosa Med Ctr / Baptist Med Ctr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

Patients must have:

• Documented and confirmed HIV infection.
• Limited or no experience with antiretrovirals.
• CD4+ lymphocyte cell count of 50 cells/mm3 or more 14 days prior to study drug administration.
• HIV-1 plasma RNA above 40 copies/ml and less than 100,000 copies/ml within 14 days prior to study drug administration.
• Ability to read, comprehend, and record information in fifth-grade English.
• Ability to attend the 4 sessions of T.H.E. course on Weeks 1-4.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Patients suffering from a serious medical condition such as diabetes, congestive heart failure, cardiomyopathy, or other cardiac dysfunction which would compromise the safety of the patient.
• Malabsorption syndrome or other gastrointestinal dysfunction which may interfere with drug absorption or render the patient unable to take oral medication.
• Acute or chronic active hepatitis.

Concurrent Treatment:

Excluded:

Treatment with foscarnet or other agents with required documented activity against HIV-1 in vitro.

Patients with the following prior conditions are excluded:

• A clinical diagnosis of AIDS, according to the 1993 Centers for Disease Control (CDC) AIDS surveillance definition. (CD4 cell counts below 200 cells/mm3 will not be considered AIDS-defining.)
• History of allergy to any study drug.

Prior Medication:

Excluded:

• History of antiretroviral use. Patients with a history of sequential nucleoside monotherapy will be excluded, as will patients with a total antiretroviral history exceeding 6 months.
• Required treatment with immunomodulating agents, such as systemic corticosteroids, interleukins, vaccines, or interferons, within 4 weeks prior to study entry, or an HIV immunotherapeutic vaccine within 3 months prior to entry. Asthmatic patients using inhaled corticosteroids are eligible for enrollment.

Prior Treatment:

Excluded:

Radiation therapy or cytotoxic chemotherapeutic agents received within 4 weeks prior to entry.

Risk Behavior:

Excluded:

Current alcohol or illicit drug use which may interfere with the ability to comply with dosing schedule and protocol evaluation and assessment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

Collaborators and Investigators

• Sponsor: Glaxo Wellcome
• Investigators: Study Chair: K Rawlings

Study record dates

Study Registration Dates

• First Submitted: November 2, 1999
• First Submitted That Met QC Criteria: August 30, 2001
• First Posted (Estimate): August 31, 2001

Study Record Updates

• Last Update Posted (Estimate): June 24, 2005
• Last Update Submitted That Met QC Criteria: June 23, 2005
• Last Verified: June 1, 1999

More Information

Terms related to this study

• Keywords: Drug Therapy, Combination; Reverse Transcriptase Inhibitors; Anti-HIV Agents; Lamivudine; Viral Load; Zidovudine; HIV Protease Inhibitors; abacavir; Patient Education; Patient Compliance
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Antimetabolites; Lamivudine; Zidovudine; Abacavir; Lamivudine, zidovudine drug combination
• Other Study ID Numbers: 280B; NZTA 4006