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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Lamivudine/Zidovudine
Abacavir sulfate
Sponsored by
Glaxo Wellcome
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Drug Therapy, Combination, Zidovudine, HIV Protease Inhibitors, Lamivudine, Patient Education, Patient Compliance, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load, abacavir

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • AIDS Healthcare Foundation
  • Oasis Clinic / King Drew Med Ctr
  • Robert Scott MD
  • Georgetown Univ Med Ctr
  • Whitman Walker Clinic/Elizabeth Taylor Med Ctr
  • Univ of Miami School of Medicine
  • Specialty Med Care Ctrs of South Florida Inc
  • Saint Josephs Comprehensive Research Institute
  • AIDS Research Consortium of Atlanta
  • Rush Med College / Dept of Infectious Diseases
  • Encounter Med Group
  • New England Med Ctr / Div of Geo Med & Infect Disease
  • Jeffrey Bomser Clinic / NJCR
  • UMDNJ / Dept of Ob/Gyn
  • Newark Community Health Ctr
  • Addiction Research and Treatment Corp
  • Bentley-Salick Med Practice
  • Holmes Hosp / Univ of Cincinnati Med Ctr
  • Allegheny Univ of the Hlth Sciences / Div of Infect Diseases
  • Carolina Family Care/Denmark Med Ctr / P O Box 278
  • Univ of Tennessee
  • Univ of Tennessee / Div of Infect Dis / Dept of Med
  • Southeast Dallas Health Ctr
  • Therapeutic Concepts
  • Santa Rosa Med Ctr / Baptist Med Ctr

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Glaxo Wellcome
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1. Study Identification

Unique Protocol Identification Number
NCT00002409
Brief Title
The Effect of Teaching HIV-Infected Patients About HIV and Treatment
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 1999
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Glaxo Wellcome

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Drug Therapy, Combination, Zidovudine, HIV Protease Inhibitors, Lamivudine, Patient Education, Patient Compliance, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load, abacavir

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Enrollment
200 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Lamivudine/Zidovudine
Intervention Type
Drug
Intervention Name(s)
Abacavir sulfate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
K Rawlings
Official's Role
Study Chair
Facility Information:
Facility Name
AIDS Healthcare Foundation
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Oasis Clinic / King Drew Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90059
Country
United States
Facility Name
Robert Scott MD
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Georgetown Univ Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Whitman Walker Clinic/Elizabeth Taylor Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20009
Country
United States
Facility Name
Univ of Miami School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Specialty Med Care Ctrs of South Florida Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33142
Country
United States
Facility Name
Saint Josephs Comprehensive Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
AIDS Research Consortium of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Rush Med College / Dept of Infectious Diseases
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Encounter Med Group
City
Oak Park
State/Province
Illinois
ZIP/Postal Code
60301
Country
United States
Facility Name
New England Med Ctr / Div of Geo Med & Infect Disease
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Jeffrey Bomser Clinic / NJCR
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
UMDNJ / Dept of Ob/Gyn
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Newark Community Health Ctr
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07114
Country
United States
Facility Name
Addiction Research and Treatment Corp
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
Facility Name
Bentley-Salick Med Practice
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
Holmes Hosp / Univ of Cincinnati Med Ctr
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
452670405
Country
United States
Facility Name
Allegheny Univ of the Hlth Sciences / Div of Infect Diseases
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
Carolina Family Care/Denmark Med Ctr / P O Box 278
City
Denmark
State/Province
South Carolina
ZIP/Postal Code
29042
Country
United States
Facility Name
Univ of Tennessee
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
Facility Name
Univ of Tennessee / Div of Infect Dis / Dept of Med
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38165
Country
United States
Facility Name
Southeast Dallas Health Ctr
City
Dallas
State/Province
Texas
ZIP/Postal Code
75217
Country
United States
Facility Name
Therapeutic Concepts
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Santa Rosa Med Ctr / Baptist Med Ctr
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78205
Country
United States

12. IPD Sharing Statement

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

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