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
2 other identifiers
interventional
200
1 country
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 hiv-infections
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
June 1, 1999
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Glaxo Wellcomelead
Study Sites (25)
AIDS Healthcare Foundation
Los Angeles, California, 90027, United States
Oasis Clinic / King Drew Med Ctr
Los Angeles, California, 90059, United States
Robert Scott MD
Oakland, California, 94609, United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007, United States
Whitman Walker Clinic/Elizabeth Taylor Med Ctr
Washington D.C., District of Columbia, 20009, United States
Univ of Miami School of Medicine
Miami, Florida, 33136, United States
Specialty Med Care Ctrs of South Florida Inc
Miami, Florida, 33142, United States
Saint Josephs Comprehensive Research Institute
Tampa, Florida, 33607, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308, United States
Rush Med College / Dept of Infectious Diseases
Chicago, Illinois, 60612, United States
Encounter Med Group
Oak Park, Illinois, 60301, United States
New England Med Ctr / Div of Geo Med & Infect Disease
Boston, Massachusetts, 02111, United States
Jeffrey Bomser Clinic / NJCR
Newark, New Jersey, 07103, United States
UMDNJ / Dept of Ob/Gyn
Newark, New Jersey, 07103, United States
Newark Community Health Ctr
Newark, New Jersey, 07114, United States
Addiction Research and Treatment Corp
Brooklyn, New York, 11201, United States
Bentley-Salick Med Practice
New York, New York, 10011, United States
Holmes Hosp / Univ of Cincinnati Med Ctr
Cincinnati, Ohio, 452670405, United States
Allegheny Univ of the Hlth Sciences / Div of Infect Diseases
Philadelphia, Pennsylvania, 19102, United States
Carolina Family Care/Denmark Med Ctr / P O Box 278
Denmark, South Carolina, 29042, United States
Univ of Tennessee
Memphis, Tennessee, 38103, United States
Univ of Tennessee / Div of Infect Dis / Dept of Med
Memphis, Tennessee, 38165, United States
Southeast Dallas Health Ctr
Dallas, Texas, 75217, United States
Therapeutic Concepts
Houston, Texas, 77004, United States
Santa Rosa Med Ctr / Baptist Med Ctr
San Antonio, Texas, 78205, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
K Rawlings
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1999-06