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Home > "T" Clinical Trials Conditions > The Effect of Teaching HIV-Infected Patients about HIV and Treatment  The Effect of Teaching HIV-Infected Patients about HIV and Treatment
The Effect of Teaching HIV-Infected Patients about HIV and Treatment
For Condition: HIV Infections
Status: Completed
Sponsor(s): Glaxo Wellcome ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 200
Location and Contact Information:
Overall Study Official:
KRawlings, Study Chair,
Allegheny Univ of the Hlth Sciences / Div of Infect Diseases
Philadelphia, Pennsylvania, 19102
United States
Therapeutic Concepts
Houston, Texas, 77004
United States
Southeast Dallas Health Ctr
Dallas, Texas, 75217
United States
Encounter Med Group
Oak Park, Illinois, 60301
United States
Carolina Family Care/Denmark Med Ctr / P O Box 278
Denmark, South Carolina, 29042
United States
Bentley-Salick Med Practice
New York City, New York, 10011
United States
Addiction Research and Treatment Corp
Brooklyn, New York, 11201
United States
Rush Med College / Dept of Infectious Diseases
Chicago, Illinois, 60612
United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
United States
Holmes Hosp / Univ of Cincinnati Med Ctr
Cincinnati, Ohio, 452670405
United States
Specialty Med Care Ctrs of South Florida Inc
Miami, Florida, 33142
United States
UMDNJ / Dept of Ob/Gyn
Newark, New Jersey, 07103
United States
Saint Josephs Comprehensive Research Institute
Tampa, Florida, 33607
United States
Santa Rosa Med Ctr / Baptist Med Ctr
San Antonio, Texas, 78205
United States
Univ of Miami School of Medicine
Miami, Florida, 33136
United States
Whitman Walker Clinic/Elizabeth Taylor Med Ctr
Washington D.C., District of Columbia, 20009
United States
Univ of Tennessee
Memphis, Tennessee, 38103
United States
Robert Scott MD
Oakland, California, 94609
United States
Oasis Clinic / King Drew Med Ctr
Los Angeles, California, 90059
United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
United States
Univ of Tennessee / Div of Infect Dis / Dept of Med
Memphis, Tennessee, 38165
United States
Jeffrey Bomser Clinic / NJCR
Newark, New Jersey, 07103
United States
New England Med Ctr / Div of Geo Med & Infect Disease
Boston, Massachusetts, 02111
United States
AIDS Healthcare Foundation
Los Angeles, California, 90027
United States
Newark Community Health Ctr
Newark, New Jersey, 07114
United States
Additional Information:
Study ID Numbers: 280B; NZTA 4006
Study Start Date:
Record last reviewed: June 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002409
Other Hiv Infections Studies:
1. Safety and Effectiveness of Four Anti-HIV Drug Combinations in HIV-Infected Children and Teens
2. Oral Manifestations of Human Immunodeficiency Virus Infection in High Risk Groups
3. Differences Between Women and Men Taking a Combination of Indinavir, Ritonavir, Enteric-Coated Didanosine, and Stavudine Who Previously Took Anti-HIV Drugs
4. A Phase I Study of Autologous, Activated CD8(+) Lymphocytes Expanded In Vitro and Infused With or Without Recombinant Interleukin-2 to Patients With AIDS or Severe ARC
5. Using Nevirapine to Prevent Mother-to-Child HIV Transmission During Breastfeeding
Related Studies:
Other HIV Infections Clinical Trials
Other Florida Clinical Trials
Other Miami Clinical Trials
The Effect of Teaching HIV-Infected Patients about HIV and Treatment
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