The Effect of Teaching HIV-Infected Patients About HIV and Treatment
NCT ID: NCT00002409
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
200 participants
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
Interventions
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Lamivudine/Zidovudine
Abacavir sulfate
Eligibility Criteria
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Inclusion Criteria
* 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
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.
18 Years
ALL
No
Sponsors
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Glaxo Wellcome
INDUSTRY
Principal Investigators
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K Rawlings
Role: STUDY_CHAIR
Locations
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AIDS Healthcare Foundation
Los Angeles, California, United States
Oasis Clinic / King Drew Med Ctr
Los Angeles, California, United States
Robert Scott MD
Oakland, California, United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, United States
Whitman Walker Clinic/Elizabeth Taylor Med Ctr
Washington D.C., District of Columbia, United States
Univ of Miami School of Medicine
Miami, Florida, United States
Specialty Med Care Ctrs of South Florida Inc
Miami, Florida, United States
Saint Josephs Comprehensive Research Institute
Tampa, Florida, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States
Rush Med College / Dept of Infectious Diseases
Chicago, Illinois, United States
Encounter Med Group
Oak Park, Illinois, United States
New England Med Ctr / Div of Geo Med & Infect Disease
Boston, Massachusetts, United States
Jeffrey Bomser Clinic / NJCR
Newark, New Jersey, United States
UMDNJ / Dept of Ob/Gyn
Newark, New Jersey, United States
Newark Community Health Ctr
Newark, New Jersey, United States
Addiction Research and Treatment Corp
Brooklyn, New York, United States
Bentley-Salick Med Practice
New York, New York, United States
Holmes Hosp / Univ of Cincinnati Med Ctr
Cincinnati, Ohio, United States
Allegheny Univ of the Hlth Sciences / Div of Infect Diseases
Philadelphia, Pennsylvania, United States
Carolina Family Care/Denmark Med Ctr / P O Box 278
Denmark, South Carolina, United States
Univ of Tennessee
Memphis, Tennessee, United States
Univ of Tennessee / Div of Infect Dis / Dept of Med
Memphis, Tennessee, United States
Southeast Dallas Health Ctr
Dallas, Texas, United States
Therapeutic Concepts
Houston, Texas, United States
Santa Rosa Med Ctr / Baptist Med Ctr
San Antonio, Texas, United States
Countries
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Other Identifiers
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NZTA 4006
Identifier Type: -
Identifier Source: secondary_id
280B
Identifier Type: -
Identifier Source: org_study_id