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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002409
• Other study ID #: 280B
• Secondary ID: NZTA 4006
• Status: Completed
• Phase: Phase 3
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: June 1999
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

Following initial screening, eligible patients are treated with open-label Combivir plus abacavir for 24 weeks. Patients are randomized to undergo the education intervention, Tools for Health and Empowerment (T.H.E.) course plus counseling, or routine counseling only (control group). Measurements and evaluations for assessment of immunologic effects, adherence, and health outcomes are performed at entry (Day 1) and at Weeks 2, 5, 8, 12, 16, and 24.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Lamivudine/Zidovudine

• Abacavir sulfate

Locations

Country	Name	City	State
United States	AIDS Research Consortium of Atlanta	Atlanta	Georgia
United States	New England Med Ctr / Div of Geo Med & Infect Disease	Boston	Massachusetts
United States	Addiction Research and Treatment Corp	Brooklyn	New York
United States	Rush Med College / Dept of Infectious Diseases	Chicago	Illinois
United States	Holmes Hosp / Univ of Cincinnati Med Ctr	Cincinnati	Ohio
United States	Southeast Dallas Health Ctr	Dallas	Texas
United States	Carolina Family Care/Denmark Med Ctr / P O Box 278	Denmark	South Carolina
United States	Therapeutic Concepts	Houston	Texas
United States	AIDS Healthcare Foundation	Los Angeles	California
United States	Oasis Clinic / King Drew Med Ctr	Los Angeles	California
United States	Univ of Tennessee	Memphis	Tennessee
United States	Univ of Tennessee / Div of Infect Dis / Dept of Med	Memphis	Tennessee
United States	Specialty Med Care Ctrs of South Florida Inc	Miami	Florida
United States	Univ of Miami School of Medicine	Miami	Florida
United States	Bentley-Salick Med Practice	New York	New York
United States	Jeffrey Bomser Clinic / NJCR	Newark	New Jersey
United States	Newark Community Health Ctr	Newark	New Jersey
United States	UMDNJ / Dept of Ob/Gyn	Newark	New Jersey
United States	Encounter Med Group	Oak Park	Illinois
United States	Robert Scott MD	Oakland	California
United States	Allegheny Univ of the Hlth Sciences / Div of Infect Diseases	Philadelphia	Pennsylvania
United States	Santa Rosa Med Ctr / Baptist Med Ctr	San Antonio	Texas
United States	Saint Josephs Comprehensive Research Institute	Tampa	Florida
United States	Georgetown Univ Med Ctr	Washington	District of Columbia
United States	Whitman Walker Clinic/Elizabeth Taylor Med Ctr	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Glaxo Wellcome

Country where clinical trial is conducted

United States,