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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002409
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: June 1999
  Purpose

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 Intervention Phase
HIV Infections
Drug: Lamivudine/Zidovudine
Drug: Abacavir sulfate
Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 200
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002409

  Show 25 Study Locations
Sponsors and Collaborators
Glaxo Wellcome
Investigators
Study Chair: K Rawlings
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002409     History of Changes
Other Study ID Numbers: 280B, NZTA 4006
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination
Zidovudine
HIV Protease Inhibitors
Lamivudine
Patient Education
Patient Compliance
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load
abacavir

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Zidovudine
Lamivudine
Reverse Transcriptase Inhibitors
Abacavir
Lamivudine, zidovudine drug combination
HIV Protease Inhibitors
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents
Protease Inhibitors

ClinicalTrials.gov processed this record on September 14, 2014