HIV InfectionsPhase 3NCT00002409
The Effect of Teaching HIV-Infected Patients About HIV and Treatment
A Phase 3 study testing Lamivudine/Zidovudine and Abacavir sulfate in people with HIV Infections, run by Glaxo Wellcome at 25 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Lamivudine/Zidovudine and Abacavir sulfate
- How many people
- 200 participants
- Where
- 25 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 21Show fewer
- 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.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
New England Med Ctr / Div of Geo Med & Infect Disease
Boston, Massachusetts, 02111
Addiction Research and Treatment Corp
Brooklyn, New York, 11201
Rush Med College / Dept of Infectious Diseases
Chicago, Illinois, 60612
Holmes Hosp / Univ of Cincinnati Med Ctr
Cincinnati, Ohio, 452670405
Southeast Dallas Health Ctr
Dallas, Texas, 75217
Carolina Family Care/Denmark Med Ctr / P O Box 278
Denmark, South Carolina, 29042
Therapeutic Concepts
Houston, Texas, 77004
AIDS Healthcare Foundation
Los Angeles, California, 90027
Oasis Clinic / King Drew Med Ctr
Los Angeles, California, 90059
Univ of Tennessee
Memphis, Tennessee, 38103
Univ of Tennessee / Div of Infect Dis / Dept of Med
Memphis, Tennessee, 38165
Univ of Miami School of Medicine
Miami, Florida, 33136
Specialty Med Care Ctrs of South Florida Inc
Miami, Florida, 33142
Bentley-Salick Med Practice
New York, New York, 10011
Jeffrey Bomser Clinic / NJCR
Newark, New Jersey, 07103
UMDNJ / Dept of Ob/Gyn
Newark, New Jersey, 07103
Newark Community Health Ctr
Newark, New Jersey, 07114
Encounter Med Group
Oak Park, Illinois, 60301
Robert Scott MD
Oakland, California, 94609
Allegheny Univ of the Hlth Sciences / Div of Infect Diseases
Philadelphia, Pennsylvania, 19102
Santa Rosa Med Ctr / Baptist Med Ctr
San Antonio, Texas, 78205
Saint Josephs Comprehensive Research Institute
Tampa, Florida, 33607
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
Whitman Walker Clinic/Elizabeth Taylor Med Ctr
Washington D.C., District of Columbia, 20009
About this study
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
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.
Read the 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.
- Conditions
- HIV Infections
- Being tested
- Lamivudine/Zidovudine, Abacavir sulfate
- Keywords
- Drug Therapy, Combination, Zidovudine, HIV Protease Inhibitors, Lamivudine, Patient Education, Patient Compliance, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load, abacavir
- Medical subject headings
- HIV Infections, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lamivudine/ZidovudineDrug
Abacavir sulfateDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Glaxo Wellcome
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- K Rawlings, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002409
- Sponsor's protocol ID
- 280B
- Other IDs
- NZTA 4006
- Status last verified
- Jun 1999
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00002409
- Acronym / sponsor ID
- 280B
- Conditions
- HIV Infections
- Keywords
- Drug Therapy, Combination, Zidovudine, HIV Protease Inhibitors, Lamivudine, Patient Education, Patient Compliance, Reverse Transcriptase Inhibitors, Anti-HIV Agents
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- Glaxo WellcomeIndustry (pharma, biotech, devices)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
- Treatment with foscarnet or other agents with required documented activity against HIV-1 in vitro.
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lamivudine/Zidovudine | Drug | – |
| Abacavir sulfate | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
K Rawlings study chair
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lamivudine/Zidovudine and Abacavir sulfate in people with HIV Infections, run by Glaxo Wellcome at 25 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.