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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Glaxo Wellcome
• Treatments: Abacavir; Lamivudine; Lamivudine, zidovudine drug combination; Zidovudine

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.