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

Completed · Phase 3

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00002409

Run by

Glaxo Wellcome

People needed

200

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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