Completed
Education Intervention and Triple Nucleoside Therapy for HIV-Infected Patients
What is being tested
Lamivudine/Zidovudine
+ Abacavir sulfate
Drug
Who is being recruted
Treatment Adherence and Compliance+16
+ Blood-Borne Infections
+ Urogenital Diseases
Over 18 Years
+16 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 3
Interventional
Summary
Principal SponsorGlaxo Wellcome
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
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.
Principal SponsorGlaxo Wellcome
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
200 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Treatment Adherence and ComplianceBlood-Borne InfectionsUrogenital DiseasesGenital DiseasesBehaviorCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsPatient Acceptance of Health CareRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesVirus DiseasesSexually Transmitted Diseases, ViralHealth BehaviorLentivirus InfectionsPatient ComplianceHIV Infections
Criteria
6 inclusion criteria required to participate
Ability to read, comprehend, and record information in fifth-grade English.
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.
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10 exclusion criteria prevent from participating
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 antiretroviral use. Patients with a history of sequential nucleoside monotherapy will be excluded, as will patients with a total antiretroviral history exceeding 6 months.
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.
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.
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Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 25 locations
Oasis Clinic / King Drew Med Ctr
Los Angeles, United StatesRobert Scott MD
Oakland, United StatesGeorgetown Univ Med Ctr
Washington D.C., United StatesCompleted25 Study Centers