Clinical trial NCT00002409: The Effect of Teaching HIV-Infected Patients About HIV and 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: Drug Therapy, Combination
Zidovudine
HIV Protease Inhibitors
Lamivudine
Patient Education
Patient Compliance
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load
abacavir
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

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