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

Sponsor

Glaxo Wellcome (Industry)

Overall Status

Completed

CT.gov ID

NCT00002409

Collaborator

(none)

200

Enrollment

Locations

Patients Per Site

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Lamivudine/Zidovudine Drug: Abacavir sulfate	Phase 3

Detailed 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.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 0 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AIDS Healthcare Foundation	Los Angeles	California	United States	90027
2	Oasis Clinic / King Drew Med Ctr	Los Angeles	California	United States	90059
3	Robert Scott MD	Oakland	California	United States	94609
4	Georgetown Univ Med Ctr	Washington	District of Columbia	United States	20007
5	Whitman Walker Clinic/Elizabeth Taylor Med Ctr	Washington	District of Columbia	United States	20009
6	Univ of Miami School of Medicine	Miami	Florida	United States	33136
7	Specialty Med Care Ctrs of South Florida Inc	Miami	Florida	United States	33142
8	Saint Josephs Comprehensive Research Institute	Tampa	Florida	United States	33607
9	AIDS Research Consortium of Atlanta	Atlanta	Georgia	United States	30308
10	Rush Med College / Dept of Infectious Diseases	Chicago	Illinois	United States	60612
11	Encounter Med Group	Oak Park	Illinois	United States	60301
12	New England Med Ctr / Div of Geo Med & Infect Disease	Boston	Massachusetts	United States	02111
13	Jeffrey Bomser Clinic / NJCR	Newark	New Jersey	United States	07103
14	UMDNJ / Dept of Ob/Gyn	Newark	New Jersey	United States	07103
15	Newark Community Health Ctr	Newark	New Jersey	United States	07114
16	Addiction Research and Treatment Corp	Brooklyn	New York	United States	11201
17	Bentley-Salick Med Practice	New York	New York	United States	10011
18	Holmes Hosp / Univ of Cincinnati Med Ctr	Cincinnati	Ohio	United States	452670405
19	Allegheny Univ of the Hlth Sciences / Div of Infect Diseases	Philadelphia	Pennsylvania	United States	19102
20	Carolina Family Care/Denmark Med Ctr / P O Box 278	Denmark	South Carolina	United States	29042
21	Univ of Tennessee	Memphis	Tennessee	United States	38103
22	Univ of Tennessee / Div of Infect Dis / Dept of Med	Memphis	Tennessee	United States	38165
23	Southeast Dallas Health Ctr	Dallas	Texas	United States	75217
24	Therapeutic Concepts	Houston	Texas	United States	77004
25	Santa Rosa Med Ctr / Baptist Med Ctr	San Antonio	Texas	United States	78205