Overview

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.